For various types of drug approval processes like INDs, NDAs, ANDAs, veterinary drug approval, the data related to bioanalytical method development and validation is needed to sponsors. Various agencies namely US FDA, American association of pharmaceutical scientists (AAPS), Health protection Branch (HPB), Association of analytical chemists (AOAC), Center for Veterinary Medicine (CVM), U.S. Department of Health and Human Services Food and drug Administration, Center for Drug Evaluation and Research (CDER), European Medicine Agency (EMA), China Food and Drug administration(CFDA), European Bioanalytical Forum (EBF), Global CRO council (GCC), ANVISA (Brazil), Japan Bioanalytical Forum (JBF) had done collective efforts at different timings to regulate and harmonize bioanalytical method development and validation.
Part of the book: Recent Advances in Analytical Chemistry
According to the International Conference for Harmonization (ICH), the validation and verification data must be included in the Electronic Common Technical Document. The validated analytical procedure gets automatically Food and drug approved (FDA) if it is part of New drug application (NDA), Abbreviated new drug application (ANDA) or Biologic license application (BLA). The analytical, bioanalytical and stability-indicating methods are essential part of all above said regulatory submissions. There are certain ways to generate these analytical methods like U.S. pharmacopeia/National Formulary which are Food and drug approved. The validated analytical method can also be submitted by any researcher or agency which can gets the food and drug approval. It is necessary that the methods which are Food and drug approved can only be applied to the various drugs and drugs products. In the current chapter, the meaning and requirements of analytical methods, procedures, acceptance criteria and evaluation of stability indicating methods, need, recommendations for bioanalytical methods are discussed in detail. The analytical techniques like HPTLC, HPLC, Spectrophotometry and Hyphenated techniques are also discussed as these are playing important role in validation of these methods.
Part of the book: Analytical Chemistry - Advancement, Perspectives and Applications