For various types of drug approval processes like INDs, NDAs ANDAs, veterinary drug approval process the data\nrelated to bioanalytical method development and validation is needed to sponsors. Various agencies namely US FDA, American\nAssociation of Pharmaceutical Scientists (AAPS), Health Protection Branch (HPB), Association of Analytical Chemists (AOAC),\nCenter for Veterinary Medicine (CVM), U.S. Department of Health and Human Services Food and Drug Administration, Center for\nDrug Evaluation and Research (CDER), European Medicine Agency (EMA), China Food and Drug administration (CFDA),\nEuropean Bioanalytical Forum (EBF), Global CRO council (GCC), ANVISA (Brazil), Japan Bioanalytical Forum (JBF) had done\ncollective affords at different timings to regulate and harmonize bioanalytical method development and validation. To\nharmonize bioanalytical method development and validation, the wide range of study and discussions were held during last\nthree decades including various workshop and conferences of official regulatory authorities. Regulatory guidance is available as\na result of the involvement of various official agencies. Bioanalytical method development and validation can be performed with\nvarious validation parameters by using LC-MS/MS and other analytical techniques. Also, there are various stability guidelines\nand procedures were set which are useful for bioanalysis. It is very advantageous for new researchers to have such collective\ninformation for development and validation of bioanalytical method which is presented in this review which may be upgraded\nin future. It can also be concluded that the process of formation of regulatory guidelines and up gradation of practical approach\nis constant during last three decades. The present review is having a special concern on regulatory and practical perspectives to\nresearchers for development and validation of the bioanalytical method. GLP is also one of the important factors for\nbioanalytical method development and validation.
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