Details of Horwitz values.
\r\n\tThe fundamental research areas of Evolutionary Psychology can be divided into two broad categories: on the one hand, the basic cognitive processes, and the way they evolved within the species, and on the other, the adaptive social behaviors that derive from the theory of evolution itself: survival, mating, parenting, family and kinship, interactions with non-parents and cultural evolution. Indeed, Evolutionary Psychology explains at individual and group level the fundamental behaviors of social life, such as altruism, cooperation, competition, social exclusion, social support, etc. etc. Similar to the mechanisms of natural selection for physical characteristics, not only the mind follows biological laws, but also psychological abilities - such as the theory of mind, the ability to represent the intentions, thoughts, beliefs, and emotions of others - have had to adapt and must make themselves functional to the social life of individuals and groups. In addition, Sociology takes the same aspects into consideration, emphasizing the interaction, symbolic and otherwise, of individuals. The latter investigates the neural mechanisms underlying the same social behaviors that are of interest to evolutionary psychology. To study the neural correlates involved in such behaviors is necessary to understand the biological laws that underlie human behavior and brain functioning.
\r\n\r\n\tThis book aims to open a debate full of theoretical and experimental contributions among the different disciplines in social research, psychology, neuroscience, sociology, useful to give an innovative vision to the present research and future perspective on the topic.
",isbn:"978-1-83968-871-3",printIsbn:"978-1-83968-870-6",pdfIsbn:"978-1-83968-872-0",doi:null,price:0,priceEur:0,priceUsd:0,slug:null,numberOfPages:0,isOpenForSubmission:!1,hash:"bd4df54e3fb185306ec3899db7044efb",bookSignature:"Dr. Rosalba Morese, Dr. Vincenzo Auriemma and Dr. Sara Palermo",publishedDate:null,coverURL:"https://cdn.intechopen.com/books/images_new/10450.jpg",keywords:"Evolutionary Psychology, Human Social Evolution, Human Social Behaviour, Social Cognition, Social Neuroscience, Functional Neuroimaging, Neuropsychology, Altruism, Cooperation, Social Exclusion, Social Support, Social Inclusion",numberOfDownloads:null,numberOfWosCitations:0,numberOfCrossrefCitations:null,numberOfDimensionsCitations:null,numberOfTotalCitations:null,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"September 18th 2020",dateEndSecondStepPublish:"December 21st 2020",dateEndThirdStepPublish:"February 24th 2021",dateEndFourthStepPublish:"May 15th 2021",dateEndFifthStepPublish:"July 14th 2021",remainingDaysToSecondStep:"2 months",secondStepPassed:!0,currentStepOfPublishingProcess:4,editedByType:null,kuFlag:!1,biosketch:"Dr. Rosalba Morese is carrying out research in the framework of Neuroscience and Social Psychology. She currently works at the Institute of Public Health of Faculty of Biomedical Sciences and at the Faculty of Communication, Culture, and Society of Università Della Svizzera Italiana, Lugano, Switzerland.",coeditorOneBiosketch:"Dr. Vincenzo Auriemma's focus is on the study of empathy in human interactions. He studied at the University of Essex in England, the University of Pisa, Genoa, Rome in Italy, and the University of Italian Switzerland in Switzerland. He is the principal responsible for the 'PERSEO' research which analyzes the reasons for the 'drop-out' in psychology.",coeditorTwoBiosketch:"Researcher of the EUROPEAN INNOVATION PARTNERSHIP on Active and Healthy Ageing and Assistant Specialty Chief Editor for Frontiers in Psychology - Neuropsychology.",coeditorThreeBiosketch:null,coeditorFourBiosketch:null,coeditorFiveBiosketch:null,editors:[{id:"214435",title:"Dr.",name:"Rosalba",middleName:null,surname:"Morese",slug:"rosalba-morese",fullName:"Rosalba Morese",profilePictureURL:"https://mts.intechopen.com/storage/users/214435/images/system/214435.jpg",biography:"Rosalba Morese obtained a degree in psychology at the University of Parma. She subsequently held various\nteaching positions at the Department of Psychology and the Faculty of Medicine and Surgery of the\nUniversity of Parma.\nHer training continued with the attainment of the title of PhD in Neuroscience at the University of Turin,\nduring which she acquired and developed interdisciplinary skills and point of view through the application\nof bioimaging and psychophysiological methods to investigate the neurophysiological mechanisms involved\nduring communication and social interactions.",institutionString:"Universita della Svizzera Italiana",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"6",totalChapterViews:"0",totalEditedBooks:"3",institution:{name:"Universita della Svizzera Italiana",institutionURL:null,country:{name:"Switzerland"}}}],coeditorOne:{id:"338363",title:"Dr.",name:"Vincenzo",middleName:null,surname:"Auriemma",slug:"vincenzo-auriemma",fullName:"Vincenzo Auriemma",profilePictureURL:"https://mts.intechopen.com/storage/users/no_image.jpg",biography:'He is pursuing a PhD in Sociology from the University of Salerno, Italy. He is a researcher of sociology and neurosociology at the University of Salerno, Italy. His focus is on the study of empathy in human interactions and he studied at the University of Essex in England, the University of Pisa, Genoa, Rome 3 in Italy and the University of Italian Switzerland in Switzerland. He has participated in national and international conferences with about 25 reports/communications. He is the principal responsible for the "PERSEO" research which analyzes the reasons for the "drop-out" in psychology, using the methodology of the Gounded Theory and analyzing empathy, fear and panic. He is Co-Editor for Frontiers. He is also a member of the Italian Society of Sociology (AIS).',institutionString:"University of Salerno",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"0",totalChapterViews:"0",totalEditedBooks:"0",institution:{name:"University of Salerno",institutionURL:null,country:{name:"Italy"}}},coeditorTwo:{id:"233998",title:"Ph.D.",name:"Sara",middleName:null,surname:"Palermo",slug:"sara-palermo",fullName:"Sara Palermo",profilePictureURL:"https://mts.intechopen.com/storage/users/233998/images/system/233998.jpeg",biography:"Sara Palermo is a MSc in Clinical Psychology and a PhD in Experimental Neuroscience. Moreover, she obtained the National Scientific Enabling Certificate for Associate Professorship in April 2017 (ASN-2017). She is an expert in experimental neuroscience, clinical neuropsychology and advance neuropsychological testing. Moreover, she performs multidimensional geriatric evaluation and basic neurological symptomatology detection in patients with neurodegenerative disorders. She is also engaged in Activation Likelihood Estimation meta-analysis of neuroimaging studies.\r\nShe worked as a postdoc research fellow at the Department of Neuroscience 'Rita Levi Montalcini” in Turin until July 2017. Since then she works as research fellow at the Department of Psychology in Turin. To date, she owns three research Group memberships at the University of Turin (Italy). She is a member of the 'Center for the Study of Movement Disorders” (research area: Neurology) and the 'Placebo Responses Mapping Group” (research area: Physiology) at the Department of Neuroscience, and a member of the 'Neuropsychology of cognitive impairment and central nervous system degenerative diseases Group” at the Department of Psychology (Research Area: Psychobiology and physiological psychology).\r\nThe main topics of her research are the study of awareness of illness, metacognitive-executive deficits in neuropsychiatric and neurological disorders, physical and cognitive frailty in the elderly, and placebo/nocebo phenomena. Interestingly, all of them may represent appealing perspectives from which to study how neuropsychological abnormalities can be explained in terms of brain activities and with the use of neuropsychiatric and neuropsychological batteries considering a neurocognitive approach. Given her research interests and scientific publications, she has been an ordinary member of the Italian Society of Neuropsychology (SINP), of the Italian Association of Psychogeriatrics (AIP), of the Italian Society of Neurology for Dementia (SiNdem), and – finally – of the international Society for Interdisciplinary Placebo Studies (SIPS). Importantly, she is a member of the European Innovation Partnership on Active and Healthy Aging (EIP on AHA), for which she is involved in the Action Group A3 Functional decline and frailty. \r\n\r\nSara Palermo is Panel Editor for 'EC Psychology and Psychiatry'. She was recently appointed as Specialty Chief Editor for 'Frontiers in Psychology - Neuropsychology'.",institutionString:"University of Turin",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"5",totalChapterViews:"0",totalEditedBooks:"3",institution:{name:"University of Turin",institutionURL:null,country:{name:"Italy"}}},coeditorThree:null,coeditorFour:null,coeditorFive:null,topics:[{id:"21",title:"Psychology",slug:"psychology"}],chapters:null,productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"},personalPublishingAssistant:{id:"259492",firstName:"Sara",lastName:"Gojević-Zrnić",middleName:null,title:"Mrs.",imageUrl:"https://mts.intechopen.com/storage/users/259492/images/7469_n.png",email:"sara.p@intechopen.com",biography:"As an Author Service Manager my responsibilities include monitoring and facilitating all publishing activities for authors and editors. From chapter submission and review, to approval and revision, copyediting and design, until final publication, I work closely with authors and editors to ensure a simple and easy publishing process. I maintain constant and effective communication with authors, editors and reviewers, which allows for a level of personal support that enables contributors to fully commit and concentrate on the chapters they are writing, editing, or reviewing. I assist authors in the preparation of their full chapter submissions and track important deadlines and ensure they are met. I help to coordinate internal processes such as linguistic review, and monitor the technical aspects of the process. As an ASM I am also involved in the acquisition of editors. Whether that be identifying an exceptional author and proposing an editorship collaboration, or contacting researchers who would like the opportunity to work with IntechOpen, I establish and help manage author and editor acquisition and contact."}},relatedBooks:[{type:"book",id:"5810",title:"Socialization",subtitle:"A Multidimensional Perspective",isOpenForSubmission:!1,hash:"bfac2e9c0ec2963193e9d15d617c6a01",slug:"socialization-a-multidimensional-perspective",bookSignature:"Rosalba Morese, Sara Palermo and Juri Nervo",coverURL:"https://cdn.intechopen.com/books/images_new/5810.jpg",editedByType:"Edited by",editors:[{id:"214435",title:"Dr.",name:"Rosalba",surname:"Morese",slug:"rosalba-morese",fullName:"Rosalba Morese"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"7818",title:"Social Isolation",subtitle:"An Interdisciplinary View",isOpenForSubmission:!1,hash:"db3b513d7d35476f333a0d4a3147935b",slug:"social-isolation-an-interdisciplinary-view",bookSignature:"Rosalba Morese, Sara Palermo and Raffaella Fiorella",coverURL:"https://cdn.intechopen.com/books/images_new/7818.jpg",editedByType:"Edited by",editors:[{id:"214435",title:"Dr.",name:"Rosalba",surname:"Morese",slug:"rosalba-morese",fullName:"Rosalba Morese"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"8262",title:"The New Forms of Social Exclusion",subtitle:null,isOpenForSubmission:!1,hash:"29bf235aa7659d3651183fe9ea49dc0d",slug:"the-new-forms-of-social-exclusion",bookSignature:"Rosalba Morese and Sara Palermo",coverURL:"https://cdn.intechopen.com/books/images_new/8262.jpg",editedByType:"Edited by",editors:[{id:"214435",title:"Dr.",name:"Rosalba",surname:"Morese",slug:"rosalba-morese",fullName:"Rosalba Morese"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"6494",title:"Behavior Analysis",subtitle:null,isOpenForSubmission:!1,hash:"72a81a7163705b2765f9eb0b21dec70e",slug:"behavior-analysis",bookSignature:"Huei-Tse Hou and Carolyn S. 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Method validation is a procedure of performing numerous assessments designed to verify that an analytical test system is suitable for its intended reason and is capable of providing beneficial and legitimate analytical data [4, 5, 6, 7, 8]. A validation examine includes testing multiple attributes of a method to determine that it may provide useful and valid facts whilst used robotically [9, 10, 11]. To accurately investigate method parameters, the validation test ought to consist of normal test conditions, which includes product excipients [11, 12, 13, 14]. Therefore, a method validation examine is product-specific.
Selectivity/Specificity
Precision
Accuracy
Linearity
Range
Stability
Limit of Detection (LOD) and Limit of Quantitation (LOQ)
Selectivity of an analytical method is its ability to measure accurately an analyte in the presence of interferences that may be expected to be present in the sample matrix.
Selectivity is checked by examining chromatographic blanks (from a sample that is known to contain no analyte) in the expected time window of the analyte peak. And the raw data for selectivity will be recorded in the raw data in approved formats.
Precision of a method is the degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings.
Precision is measured by injecting a series of standards or analyzing series of samples from multiple samplings from a homogeneous lot. From the measured standard deviation (SD) and Mean values, precision as relative standard deviation (% rsd) is calculated.
The raw data for precision will be recorded in the approved format and the acceptance criteria for precision will be given in the respective study plan or amendment to the study plan.
OR
Precision can be also calculated by using Horwitz equation:
The acceptable percent of relative standard deviation results for precision may be based on the Horwitz equation, an exponential relationship between the among-laboratory relative standard deviation (RSDR) and Concentration (C): [15]
For estimation of repeatability (RSDr), is modified to:
The Horwitz curve has been empirically derived and has been proven to be more or less independent of analyte, matrix and method of evaluation over the concentration range C = 1 (100%) to C = 10−9 by the evaluation of vast numbers of method precision studies. The modified Horwitz values for repeatability CV given under may be used for guidance. If measured repeatability is outside those values, suggested explanation must be submitted for consideration. The details were presented in Table 1.
Percent of analyte | Proposed acceptable % RSDr (Horwitz value × 0.67) |
---|---|
100.00 | 1.340 |
50.00 | 1.490 |
20.00 | 1.710 |
10.00 | 1.900 |
5.00 | 2.100 |
2.00 | 2.410 |
1.00 | 2.680 |
0.25 | 3.300 |
Details of Horwitz values.
Note: The unmodified Horwitz equation is used as a criterion of acceptability for methods collaboratively tested by CIPAC.
The accuracy of an analytical method is the degree of agreement of test results generated by the method to the true value.
Accuracy is measured by spiking the sample matrix of interest with a known concentration of analyte standard and analyzing the sample using the “method being validated.” The procedure and calculation for Accuracy (as% recovery) will be varied from matrix to matrix and it will be given in respective study plan or amendment to the study plan.
The linearity of an analytical method is its capability to elicit check consequences which might be at once, or with the aid of well described mathematical adjustments, proportional to the concentration of analytes in within a given range.
Linearity is determined by injecting a series of standards of stock solution/diluted stock solution using the solvent/mobile phase, at a minimum of five different concentrations in the range of 50–150% of the expected working range. The linearity graph will be plotted manually/using Microsoft Excel or software of the computer (Concentration vs. Peak Area Response) and which will be attached to respective study files.
The range of an analytical method is the interval between the upper and lower levels that have been demonstrated to be determined with precision, accuracy and linearity using the set method. This range will be the concentration range in which the Linearity test is done.
Many analytes readily decompose prior to chromatography investigations, for example during the preparation of the sample solutions, during extraction, clean-up, phase transfer, and during storage of prepared vials. Under these circumstances, method development should investigate the stability of the analyte. Accuracy test takes care of stability. It is required to mention in the method how long a sample after extraction can be stored before final analysis, based on the duration taken for accuracy test.
The term LOD is defined as the lowest concentration at which the instrument is able to detect but not quantify and the noise to signal ratio for LOD should be 1:3. The term LOQ is defined as the lowest concentration at which the instrument is able to detect and quantify. The noise to signal ratio for LOQ should be 1:10.
Determination of Limit of Detection (LOD) and Limit of Quantitation (LOQ) from Detector Linearity experiments (applicable to only instrument sensitivity).
LOD and LOQ values are calculated manually by taking Noise to signal ratio of a lowest/known concentration of linearity samples and it will be expressed in μg/ml or ppm. To calculate in %, values of LOD and LOQ will be multiplied by 100/lowest or known concentration of test item (mg/L) taken for analysis of that particular a.i. or impurity analysis.
Calculations of LOD and LOQ values for instrument sensitivity:
Calculations of LOD and LOQ values for method:
OR
Prepare a series of standard solutions (minimum five concentrations covering working concentrations used for routine analysis) and analyze each solution minimum twice and record the instruments response.
Using the concentrations and corresponding instrument response, LOD and LOQ can be calculated as follows:
Let the linear regression equation be
Where, X and Y are the variables (data of two parameters). Generally, X is called the independent variable and Y, the dependent variable.
Take concentration on X-axis and instrument response on Y-axis.
“a” and “b” are the regression constants. Further, “a” is known as the intercept and “b,” the slope of the line.
Let (X1, Y1), (X2, Y2), (X3, Y3)…(Xn, Yn) be the set of values required to be fit in the linear equation.
a. Method of arriving at “a” and “b”
Tabulate as given below:
X1 Y1
X2 Y2
. .
. .
. .
Xn Yn
____________________________________
____________________________________
ii. Calculate the following parameters:
iii. Calculate the slope “b,” and intercept “a” as given below:
b. Method of calculation r (correlation coefficient)
c. Method of calculation standard deviation for “a” and “b”
The standard deviation of the individual deviations of measured values in Y, above and below the linear line (fitted line) is:
From this, the standard deviation for “a” and “b” are calculated.
Standard deviation
for “a,” represented =
as Sa
Standard deviation.
For “b,” represented =
as Sb
When Sa is obtained for a linear calibration line, then it provides a clear information on the standard deviation of the “Blank” (or Control) response from the instruments.
The LOD and LOQ can be worked out, as given below:
Note:
The above calculations can be programmed in a computer but before every use, the computer program must be validated using the example given in section
The above procedure can also be used for obtaining LOD and LOQ of the method from recovery test results by taking fortified concentration on X-axis and obtained concentrations on Y-axis.
In this example, the linear regression equation is employed to find out the extent of linear response of an Detector to a reference analytical standard in the concentration range of about 0.2–3.0 ppm.
Each of these working standards is injected thrice (1 μl per injection), and the peak area counts corresponding to the active ingredient peak are given below.
From the peak areas corresponding to each concentration level, the mean, standard deviation (SD) and coefficient of variation (%CV) are also calculated. The details were presented in Table 2.
Conc. of standard solution (μg/ml) | Peak area | Mean | SD (n − 1) | %CV | ||
---|---|---|---|---|---|---|
1 | 2 | 3 | ||||
0.1956 | 32,827 | 33,299 | 32,731 | 32,952 | 304 | 0.923 |
0.4890 | 87,783 | 88,480 | 87,446 | 87,903 | 527 | 0.600 |
0.9780 | 176,037 | 174,675 | 177,203 | 175,972 | 1265 | 0.719 |
1.467 | 246,212 | 250,786 | 246,849 | 247,949 | 2477 | 0.999 |
1.956 | 319,143 | 319,615 | 315,316 | 318,025 | 2358 | 0.741 |
2.934 | 415,059 | 410,773 | 418,407 | 414,746 | 3827 | 0.923 |
Calculation details of mean, SD, and %CV.
%CV = SD × 100/Mean: The coefficient of variation (CV) shows that the Injection variation is less than 1%.
Fitting the data of concentration of standard solution and mean detector response (peak area counts) in a linear equation
Let the equation be
Where, Y = Mean peak area counts and X = Concentration of standard solution, μg/ml.
The calculations were presented in Table 3.
Using the above parameters, calculate the following
Calculation of a, b, and r
Note: Sometimes r2 is also used to express the goodness of fit.
Calculation of standard deviation for a and b:
The standard deviation for a is calculated as:
The standard deviation for b is calculated as
Note: Assay procedures vary from highly exacting analytical determinations to subjective evaluations of attributes. Therefore different test methods require different validation schemes.
Category I
Analytical methods for quantitation of major excipients and/or active ingredients, and preservatives in finished goods.
Category II
Analytical methods for determination of impurities or degradation compounds in finished goods. These methods include quantitative assays and limit tests, titrimetric and bacterial endotoxin tests.
Category III
Analytical methods for determination of performance characteristics, e.g., sterility testing, dissolution and drug release for pharmaceutical products.
Data Elements Required for Assay Validation.
Details of required validation parameters of assay presented in Table 4.
Sl. no. | Y | X |
---|---|---|
1. | 32952 | 0.1956 |
2. | 87903 | 0.4890 |
3. | 175972 | 0.9780 |
4. | 247949 | 1.4670 |
5. | 318025 | 1.9560 |
6. | 414746 | 2.9340 |
Calculation details of additional parameters.
Analytical validation data playing a fundamental role in pharmaceutical industry, pesticide industry for releasing the economic batch and long term stability information consequently, the records must be produced to suited regulatory authority requirements.
IntechOpen aims to guarantee that original material is published while at the same time giving significant freedom to our Authors. We uphold a flexible Copyright Policy, guaranteeing that there is no transfer of copyright to the publisher and Authors retain exclusive copyright to their Work.
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\\n\\nThe Author and Co-Authors confirm and warrant that the Work does not and will not breach any applicable law or the rights of any third party and, specifically, that the Work contains no matter that is defamatory or that infringes any literary or proprietary rights, intellectual property rights, or any rights of privacy.
\\n\\nThe Author and Co-Authors confirm that: (i) the Work is their original work and is not copied wholly or substantially from any other work or material or any other source; (ii) the Work has not been formally published in any other peer-reviewed journal or in a book or edited collection, and is not under consideration for any such publication; (iii) Authors and any applicable Co-Authors are qualifying persons under section 154 of the Copyright, Designs and Patents Act 1988; (iv) Authors and any applicable Co-Authors have not assigned, and will not during the term of this Publication Agreement purport to assign, any of the rights granted to IntechOpen under this Publication Agreement; and (v) the rights granted by this Publication Agreement are free from any security interest, option, mortgage, charge or lien.
\\n\\nThe Author and Co-Authors also confirm and warrant that: (i) he/she has the power to enter into this Publication Agreement on his or her own behalf and on behalf of each Co-Author; and (ii) has the necessary rights and/or title in and to the Work to grant IntechOpen, on behalf of themselves and any Co-Author, the rights and licences in this Publication Agreement. If the Work was prepared jointly by the Author and Co-Authors, the Author confirms that: (i) all Co-Authors agree to the submission, license and publication of the Work on the terms of this Publication Agreement; and (ii) the Author has the authority to enter into this biding Publication Agreement on behalf of each Co-Author. The Author shall: (i) ensure each Co-Author complies with all relevant provisions of this Publication Agreement, including those relating to confidentiality, performance and standards, as if a party to this Publication Agreement; and (ii) remain primarily liable for all acts and/or omissions of each Co-Author.
\\n\\nThe Author agrees to indemnify IntechOpen harmless against all liabilities, costs, expenses, damages and losses, as well as all reasonable legal costs and expenses suffered or incurred by IntechOpen arising out of, or in connection with, any breach of the agreed confirmations and warranties. This indemnity shall not apply in a situation in which a claim results from IntechOpen's negligence or willful misconduct.
\\n\\nNothing in this Publication Agreement shall have the effect of excluding or limiting any liability for death or personal injury caused by negligence or any other liability that cannot be excluded or limited by applicable law.
\\n\\nTERMINATION
\\n\\nIntechOpen has the right to terminate this Publication Agreement for quality, program, technical or other reasons with immediate effect, including without limitation (i) if the Author and/or any Co-Author commits a material breach of this Publication Agreement; (ii) if the Author and/or any Co-Author (being a private individual) is the subject of a bankruptcy petition, application or order; or (iii) if the Author and/or any Co-Author (as a corporate entity) commences negotiations with all or any class of its creditors with a view to rescheduling any of its debts, or makes a proposal for, or enters into, any compromise or arrangement with any of its creditors.
\\n\\nIn the event of termination, IntechOpen will notify the Author of the decision in writing.
\\n\\nIntechOpen’s DUTIES AND RIGHTS
\\n\\nUnless prevented from doing so by events beyond its reasonable control, IntechOpen, at its discretion, agrees to publish the Work attributing it to the Author and Co-Authors.
\\n\\nUnless prevented from doing so by events beyond its reasonable control, IntechOpen agrees to provide publishing services which include: managing editing (editorial and publishing process coordination, Author assistance); publishing software technology; language copyediting; typesetting; online publishing; hosting and web management; and abstracting and indexing services.
\\n\\nIntechOpen agrees to offer free online access to readers and use reasonable efforts to promote the Publication to relevant audiences.
\\n\\nIntechOpen is granted the authority to enforce the rights from this Publication Agreement on behalf of the Author and Co-Authors against third parties, for example in cases of plagiarism or copyright infringements. In respect of any such infringement or suspected infringement of the copyright in the Work, IntechOpen shall have absolute discretion in addressing any such infringement that is likely to affect IntechOpen's rights under this Publication Agreement, including issuing and conducting proceedings against the suspected infringer.
\\n\\nIntechOpen has the right to include/use the Author and Co-Authors names and likeness in connection with scientific dissemination, retrieval, archiving, web hosting and promotion and marketing of the Work and has the right to contact the Author and Co-Authors until the Work is publicly available on any platform owned and/or operated by IntechOpen.
\\n\\nMISCELLANEOUS
\\n\\nFurther Assurance: The Author shall ensure that any relevant third party, including any Co-Author, shall execute and deliver whatever further documents or deeds and perform such acts as IntechOpen reasonably requires from time to time for the purpose of giving IntechOpen the full benefit of the provisions of this Publication Agreement.
\\n\\nThird Party Rights: A person who is not a party to this Publication Agreement may not enforce any of its provisions under the Contracts (Rights of Third Parties) Act 1999.
\\n\\nEntire Agreement: This Publication Agreement constitutes the entire agreement between the parties in relation to its subject matter. It replaces all prior agreements, draft agreements, arrangements, collateral warranties, collateral contracts, statements, assurances, representations and undertakings of any nature made by, or on behalf of, the parties, whether oral or written, in relation to that subject matter. Each party acknowledges that in entering into this Publication Agreement it has not relied upon any oral or written statements, collateral or other warranties, assurances, representations or undertakings which were made by or on behalf of the other party in relation to the subject matter of this Publication Agreement at any time before its signature (known as the "Pre-Contractual Statements"), other than those which are set out in this Publication Agreement. Each party hereby waives all rights and remedies which might otherwise be available to it in relation to such Pre-Contractual Statements. Nothing in this clause shall exclude or restrict the liability of either party arising out of any fraudulent pre-contract misrepresentation or concealment.
\\n\\nWaiver: No failure or delay by a party to exercise any right or remedy provided under this Publication Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall preclude or restrict the further exercise of that or any other right or remedy.
\\n\\nVariation: No variation of this Publication Agreement shall have effect unless it is in writing and signed by the parties, or their duly authorized representatives.
\\n\\nSeverance: If any provision, or part-provision, of this Publication Agreement is, or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted. Any modification to, or deletion of, a provision or part-provision under this clause shall not affect the validity and enforceability of the rest of this Publication Agreement.
\\n\\nNo partnership: Nothing in this Publication Agreement is intended to, or shall be deemed to, establish or create any partnership or joint venture or the relationship of principal and agent or employer and employee between IntechOpen and the Author or any Co-Author, nor authorize any party to make or enter into any commitments for, or on behalf of, any other party.
\\n\\nGoverning law: This Publication Agreement and any dispute or claim, including non-contractual disputes or claims arising out of, or in connection with it, or its subject matter or formation, shall be governed by and construed in accordance with the law of England and Wales. The parties submit to the exclusive jurisdiction of the English courts to settle any dispute or claim arising out of, or in connection with, this Publication Agreement, including any non-contractual disputes or claims.
\\n\\nPolicy last updated: 2018-09-11
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\n\nCORRESPONDING AUTHOR'S GRANT OF RIGHTS
\n\nSubject to the following Article, the Author grants to IntechOpen, during the full term of copyright, and any extensions or renewals of that term, the following:
\n\nThe foregoing licenses shall survive the expiry or termination of this Publication Agreement for any reason.
\n\nThe Author, on his or her own behalf and on behalf of any of the Co-Authors, reserves the following rights in the Work but agrees not to exercise them in such a way as to adversely affect IntechOpen's ability to utilize the full benefit of this Publication Agreement: (i) reprographic rights worldwide, other than those which subsist in the typographical arrangement of the Work as published by IntechOpen; and (ii) public lending rights arising under the Public Lending Right Act 1979, as amended from time to time, and any similar rights arising in any part of the world.
\n\nThe Author, and any Co-Author, confirms that they are, and will remain, a member of any applicable licensing and collecting society and any successor to that body responsible for administering royalties for the reprographic reproduction of copyright works.
\n\nSubject to the license granted above, copyright in the Work and all versions of it created during IntechOpen's editing process, including all published versions, is retained by the Author and any Co-Authors.
\n\nSubject to the license granted above, the Author and Co-Authors retain patent, trademark and other intellectual property rights to the Work.
\n\nAll rights granted to IntechOpen in this Article are assignable, sublicensable or otherwise transferrable to third parties without the specific approval of the Author or Co-Authors.
\n\nThe Author, on his/her own behalf and on behalf of the Co-Authors, will not assert any rights under the Copyright, Designs and Patents Act 1988 to object to derogatory treatment of the Work as a consequence of IntechOpen's changes to the Work arising from the translation of it, corrections and edits for house style, removal of problematic material and other reasonable edits as determined by IntechOpen.
\n\nAUTHOR'S DUTIES
\n\nWhen distributing or re-publishing the Work, the Author agrees to credit the Monograph/Compacts as the source of first publication, as well as IntechOpen. The Author guarantees that Co-Authors will also credit the Monograph/Compacts as the source of first publication, as well as IntechOpen, when they are distributing or re-publishing the Work.
\n\nThe Author agrees to:
\n\nThe Author will be held responsible for the payment of the agreed Open Access Publishing Fee before the completion of the project (Monograph/Compacts publication).
\n\nAll payments shall be due 30 days from the date of issue of the invoice. The Author or whoever is paying on behalf of the Author and Co-Authors will bear all banking and similar charges incurred.
\n\nThe Author shall obtain in writing all consents necessary for the reproduction of any material in which a third-party right exists, including quotations, photographs and illustrations, in all editions of the Work worldwide for the full term of the above licenses, and shall provide to IntechOpen, at its request, the original copies of such consents for inspection or the photocopies of such consents.
\n\nThe Author shall obtain written informed consent for publication from those who might recognize themselves or be identified by others, for example from case reports or photographs.
\n\nThe Author shall respect confidentiality during and after the termination of this Agreement. The information contained in all correspondence and documents as part of the publishing activity between IntechOpen and the Author and Co-Authors are confidential and are intended only for the recipients. The contents of any communication may not be disclosed publicly and are not intended for unauthorized use or distribution. Any use, disclosure, copying, or distribution is prohibited and may be unlawful.
\n\nAUTHOR'S WARRANTY
\n\nThe Author and Co-Authors confirm and warrant that the Work does not and will not breach any applicable law or the rights of any third party and, specifically, that the Work contains no matter that is defamatory or that infringes any literary or proprietary rights, intellectual property rights, or any rights of privacy.
\n\nThe Author and Co-Authors confirm that: (i) the Work is their original work and is not copied wholly or substantially from any other work or material or any other source; (ii) the Work has not been formally published in any other peer-reviewed journal or in a book or edited collection, and is not under consideration for any such publication; (iii) Authors and any applicable Co-Authors are qualifying persons under section 154 of the Copyright, Designs and Patents Act 1988; (iv) Authors and any applicable Co-Authors have not assigned, and will not during the term of this Publication Agreement purport to assign, any of the rights granted to IntechOpen under this Publication Agreement; and (v) the rights granted by this Publication Agreement are free from any security interest, option, mortgage, charge or lien.
\n\nThe Author and Co-Authors also confirm and warrant that: (i) he/she has the power to enter into this Publication Agreement on his or her own behalf and on behalf of each Co-Author; and (ii) has the necessary rights and/or title in and to the Work to grant IntechOpen, on behalf of themselves and any Co-Author, the rights and licences in this Publication Agreement. If the Work was prepared jointly by the Author and Co-Authors, the Author confirms that: (i) all Co-Authors agree to the submission, license and publication of the Work on the terms of this Publication Agreement; and (ii) the Author has the authority to enter into this biding Publication Agreement on behalf of each Co-Author. The Author shall: (i) ensure each Co-Author complies with all relevant provisions of this Publication Agreement, including those relating to confidentiality, performance and standards, as if a party to this Publication Agreement; and (ii) remain primarily liable for all acts and/or omissions of each Co-Author.
\n\nThe Author agrees to indemnify IntechOpen harmless against all liabilities, costs, expenses, damages and losses, as well as all reasonable legal costs and expenses suffered or incurred by IntechOpen arising out of, or in connection with, any breach of the agreed confirmations and warranties. This indemnity shall not apply in a situation in which a claim results from IntechOpen's negligence or willful misconduct.
\n\nNothing in this Publication Agreement shall have the effect of excluding or limiting any liability for death or personal injury caused by negligence or any other liability that cannot be excluded or limited by applicable law.
\n\nTERMINATION
\n\nIntechOpen has the right to terminate this Publication Agreement for quality, program, technical or other reasons with immediate effect, including without limitation (i) if the Author and/or any Co-Author commits a material breach of this Publication Agreement; (ii) if the Author and/or any Co-Author (being a private individual) is the subject of a bankruptcy petition, application or order; or (iii) if the Author and/or any Co-Author (as a corporate entity) commences negotiations with all or any class of its creditors with a view to rescheduling any of its debts, or makes a proposal for, or enters into, any compromise or arrangement with any of its creditors.
\n\nIn the event of termination, IntechOpen will notify the Author of the decision in writing.
\n\nIntechOpen’s DUTIES AND RIGHTS
\n\nUnless prevented from doing so by events beyond its reasonable control, IntechOpen, at its discretion, agrees to publish the Work attributing it to the Author and Co-Authors.
\n\nUnless prevented from doing so by events beyond its reasonable control, IntechOpen agrees to provide publishing services which include: managing editing (editorial and publishing process coordination, Author assistance); publishing software technology; language copyediting; typesetting; online publishing; hosting and web management; and abstracting and indexing services.
\n\nIntechOpen agrees to offer free online access to readers and use reasonable efforts to promote the Publication to relevant audiences.
\n\nIntechOpen is granted the authority to enforce the rights from this Publication Agreement on behalf of the Author and Co-Authors against third parties, for example in cases of plagiarism or copyright infringements. In respect of any such infringement or suspected infringement of the copyright in the Work, IntechOpen shall have absolute discretion in addressing any such infringement that is likely to affect IntechOpen's rights under this Publication Agreement, including issuing and conducting proceedings against the suspected infringer.
\n\nIntechOpen has the right to include/use the Author and Co-Authors names and likeness in connection with scientific dissemination, retrieval, archiving, web hosting and promotion and marketing of the Work and has the right to contact the Author and Co-Authors until the Work is publicly available on any platform owned and/or operated by IntechOpen.
\n\nMISCELLANEOUS
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\n\nThird Party Rights: A person who is not a party to this Publication Agreement may not enforce any of its provisions under the Contracts (Rights of Third Parties) Act 1999.
\n\nEntire Agreement: This Publication Agreement constitutes the entire agreement between the parties in relation to its subject matter. It replaces all prior agreements, draft agreements, arrangements, collateral warranties, collateral contracts, statements, assurances, representations and undertakings of any nature made by, or on behalf of, the parties, whether oral or written, in relation to that subject matter. Each party acknowledges that in entering into this Publication Agreement it has not relied upon any oral or written statements, collateral or other warranties, assurances, representations or undertakings which were made by or on behalf of the other party in relation to the subject matter of this Publication Agreement at any time before its signature (known as the "Pre-Contractual Statements"), other than those which are set out in this Publication Agreement. Each party hereby waives all rights and remedies which might otherwise be available to it in relation to such Pre-Contractual Statements. Nothing in this clause shall exclude or restrict the liability of either party arising out of any fraudulent pre-contract misrepresentation or concealment.
\n\nWaiver: No failure or delay by a party to exercise any right or remedy provided under this Publication Agreement or by law shall constitute a waiver of that or any other right or remedy, nor shall it preclude or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall preclude or restrict the further exercise of that or any other right or remedy.
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\n\nSeverance: If any provision, or part-provision, of this Publication Agreement is, or becomes invalid, illegal or unenforceable, it shall be deemed modified to the minimum extent necessary to make it valid, legal and enforceable. If such modification is not possible, the relevant provision or part-provision shall be deemed deleted. Any modification to, or deletion of, a provision or part-provision under this clause shall not affect the validity and enforceability of the rest of this Publication Agreement.
\n\nNo partnership: Nothing in this Publication Agreement is intended to, or shall be deemed to, establish or create any partnership or joint venture or the relationship of principal and agent or employer and employee between IntechOpen and the Author or any Co-Author, nor authorize any party to make or enter into any commitments for, or on behalf of, any other party.
\n\nGoverning law: This Publication Agreement and any dispute or claim, including non-contractual disputes or claims arising out of, or in connection with it, or its subject matter or formation, shall be governed by and construed in accordance with the law of England and Wales. The parties submit to the exclusive jurisdiction of the English courts to settle any dispute or claim arising out of, or in connection with, this Publication Agreement, including any non-contractual disputes or claims.
\n\nPolicy last updated: 2018-09-11
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