title: Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry.
abstract: The concepts, importance, and application of bioanalytical method validation have been discussed for a long time and validation of bioanalytical methods is widely accepted as pivotal before they are taken into routine use. United States Food and Drug Administration (USFDA) guidelines issued in 2001 have been referred for every guideline released ever since; may it be European Medical Agency (EMA) Europe, National Health Surveillance Agency (ANVISA) Brazil, Ministry of Health and Labour Welfare (MHLW) Japan or any other guideline in reference to bioanalytical method validation. After 12 years, USFDA released its new draft guideline for comments in 2013, which covers the latest parameters or topics encountered in bioanalytical method validation and approached towards the harmonization of bioanalytical method validation across the globe. Even though the regulatory agencies have general agreement, significant variations exist in acceptance criteria and methodology. The present review highlights the variations, similarities and comparison between bioanalytical method validation guidelines issued by major regulatory authorities worldwide. Additionally, other evaluation parameters such as matrix effect, incurred sample reanalysis including other stability aspects have been discussed to provide an ease of access for designing a bioanalytical method and its validation complying with the majority of drug authority guidelines.
authors.affiliation: Department of Pharmacokinetics and Metabolism, CSIR-Central Drug Research Institute, Lucknow, India.
authors.forename: Naveen
authors.initials: N
authors.lastname: Kadian
authors.affiliation: Department of Pharmacokinetics and Metabolism, CSIR-Central Drug Research Institute, Lucknow, India; Academy of Scientific and Industrial Research, New Delhi, India.
authors.forename: Kanumuri Siva Rama
authors.initials: KS
authors.lastname: Raju
authors.affiliation: Department of Pharmacokinetics and Metabolism, CSIR-Central Drug Research Institute, Lucknow, India.
authors.forename: Mamunur
authors.initials: M
authors.lastname: Rashid
authors.affiliation: Department of Pharmacokinetics and Metabolism, CSIR-Central Drug Research Institute, Lucknow, India.
authors.forename: Mohd Yaseen
authors.initials: MY
authors.lastname: Malik
authors.affiliation: Department of Pharmacokinetics and Metabolism, CSIR-Central Drug Research Institute, Lucknow, India; Academy of Scientific and Industrial Research, New Delhi, India.
authors.forename: Isha
authors.initials: I
authors.lastname: Taneja
authors.affiliation: Department of Pharmacokinetics and Metabolism, CSIR-Central Drug Research Institute, Lucknow, India; Academy of Scientific and Industrial Research, New Delhi, India. Electronic address: wahajuddin@cdri.res.in.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Wahajuddin
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000379:methods* / Q000592:standards; D004345:Drug Industry / Q000379:methods*; D017408:Guidelines as Topic; D006801:Humans; D038622:Internationality; D004364:Pharmaceutical Preparations / Q000032:analysis; D054928:Validation Studies as Topic
chemical_list: D004364:Pharmaceutical Preparations
keywords: ANVISA; Bioanalysis; EMA; MHLW; Regulatory guidance; USFDA; Validation