Open access peer-reviewed Edited Volume

Drug Development Life Cycle

Juber Akhtar

Integral University

A budding researcher with expertise in the field of nanoformulation development. Earlier nominated as Head, Faculty of Pharmacy Integral University and chairman cum biological scientist, institutional ethics committee (IAEC).

Co-editors:

Badruddeen

Integral University

Expert in the preclinical screening of drugs. Secretary IAEC, Integral University. Animal house in charge, Integral University.

Mohammad Ahmad

Integral University

Expert in preclinical pharmacology and in drug regulatory affairs. Nominated as a social nominee of CPCSEA.

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Mohammad Irfan Khan

Integral University

Expert in herbal formulation development. worked as a scientist in pharmaceutical and nutraceutical product development.

Covering

Toxicity Studies Carcinogenicity Preformulation In Vitro Analytical Techniques Stability Clinical Trials Post Marketing Surveillance Bioavailability Natural Bioenhancers BCS IV Drugs Half-Life

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About the book

This book aims to provide readers with the basic concept of drug development are scientific formulations based on preformulation data. The pure bioactive obtained from the natural sources and their developed formulations are characterized using various techniques such as FTIR, Mass Spectroscopy, NMR, HPLC/HPTLC, etc. The formulations so obtained may be optimized for stability studies as per ICH guidelines. In preclinical study developed formulations could be screened by appropriate animal models of diseases. The safe and effective doses of medicaments and their formulations could be determined based on acute and chronic toxicity studies. The in vitro methods and the data so obtained will be further analyzed and will be interpreted with non-clinical data. The in vitro in vivo correlation (IVIVC) studies will help for further clinical studies. Various regulatory aspects and approval processes for marketing authorization for both generic and patented molecules are helpful for commercialization. The data obtained from the clinical drug development phases will further help the clinician in dose adjustment for both acute and chronic conditions.

Publishing process

Book initiated and editor appointed

Date completed: December 1st 2021

Applications to edit the book are assessed and a suitable editor is selected, at which point the process begins.

Chapter proposals submitted and reviewed

Deadline Extended: Open for Submissions

Potential authors submit chapter proposals ready for review by the academic editor and our publishing review team.

Approved chapters written in full and submitted

Deadline for full chapters: February 27th 2022

Once approved by the academic editor and publishing review team, chapters are written and submitted according to pre-agreed parameters

Full chapters peer reviewed

Review results due: May 18th 2022

Full chapter manuscripts are screened for plagiarism and undergo a Main Editor Peer Review. Results are sent to authors within 30 days of submission, with suggestions for rounds of revisions.

Book compiled, published and promoted

Expected publication date: July 17th 2022

All chapters are copy-checked and typesetted before being published. IntechOpen regularly submits its books to major databases for evaluation and coverage, including the Clarivate Analytics Book Citation Index in the Web of ScienceTM Core Collection. Other discipline-specific databases are also targeted, such as Web of Science's BIOSIS Previews.

About the editor

Juber Akhtar

Integral University

Dr. Juber Akhtar obtained BPharm from Jamia Hamdard University, New Delhi, in 2005, MPharm from Manipal University, Karnataka, in 2007, and Ph.D. from Integral University, Lucknow, in 2014. He is currently employed as an associate professor at Integral University. From 2014 to 2016, Dr. Akhtar was head of the Faculty of Pharmacy, Integral University. He also served as chairman cum biological scientist for Institutional Animal Ethics Committee (IAEC) from October 2015 to May 2017. He has experience teaching abroad and was previously a professor at Buraydah College of Pharmacy and Dentistry, Kingdom of Saudi Arabia (KSA). Dr. Akhtar has more than eighty publications in reputed journals and is an editorial board member for many esteemed journals. He has supervised a dozen Ph.D. and MPharm students in research projects. Dr. Akhtar\'s areas of research interest include the development of nanoparticulate drug delivery systems.

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