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Journal of Pharmaceutical and Biomedical Analysis

Journal of Pharmaceutical and Biomedical Analysis 126 (2016) 83 97 Contents lists available at ScienceDirectJournal of Pharmaceutical and Biomedical Analysisj o ur na l ho mepage: assessment of bioanalytical method validationguidelines for Pharmaceutical industry Naveen Kadiana,1, Kanumuri Siva Rama Rajua,b,1, Mamunur Rashida,Mohd Yaseen Malika, Isha Tanejaa,b, Muhammad Wahajuddina,b, aDepartment of Pharmacokinetics and Metabolism, CSIR-Central Drug Research Institute, Lucknow, IndiabAcademy of Scientific and Industrial Research, New Delhi, Indiaa r t i c l e i n f oArticle history:Received 15 March 2016 Accepted 24 March 2016 Available online 25 March 2016 Keywords:BioanalysisValidationRegulatory guidanceUSFDAANVISAMHLWEMAa b s t r a c tThe concepts, importance, and application of bioanalytical method validation have been discussed fora long time and validation of bioanalytical methods is widely accepted as pivotal before they are takeninto routine use.

assessment of bioanalytical method validation guidelines for pharmaceutical industry Naveen Kadiana,1, Kanumuri Siva Rama Rajua ,b 1, Mamunur Rashida, Mohd ... binding assay) validation in pharmaceutical development. Although there is a general understanding between regulatory

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1 Journal of Pharmaceutical and Biomedical Analysis 126 (2016) 83 97 Contents lists available at ScienceDirectJournal of Pharmaceutical and Biomedical Analysisj o ur na l ho mepage: assessment of bioanalytical method validationguidelines for Pharmaceutical industry Naveen Kadiana,1, Kanumuri Siva Rama Rajua,b,1, Mamunur Rashida,Mohd Yaseen Malika, Isha Tanejaa,b, Muhammad Wahajuddina,b, aDepartment of Pharmacokinetics and Metabolism, CSIR-Central Drug Research Institute, Lucknow, IndiabAcademy of Scientific and Industrial Research, New Delhi, Indiaa r t i c l e i n f oArticle history:Received 15 March 2016 Accepted 24 March 2016 Available online 25 March 2016 Keywords:BioanalysisValidationRegulatory guidanceUSFDAANVISAMHLWEMAa b s t r a c tThe concepts, importance, and application of bioanalytical method validation have been discussed fora long time and validation of bioanalytical methods is widely accepted as pivotal before they are takeninto routine use.

2 United States Food and Drug Administration (USFDA) guidelines issued in 2001 havebeen 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 topicsencountered in bioanalytical method validation and approached towards the harmonization of bioana-lytical 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 thevariations, similarities and comparison between bioanalytical method validation guidelines issued bymajor regulatory authorities worldwide.

3 Additionally, other evaluation parameters such as matrix effect,incurred sample reanalysis including other stability aspects have been discussed to provide an easeof access for designing a bioanalytical method and its validation complying with the majority of drugauthority guidelines. 2016 Published by Elsevier IntroductionThe word Bioanalytics refers to the Analysis of the desired ana-lyte in biological fluids. In the present Pharmaceutical industry, thebioanalytical methods are playing a crucial role in the quantitativedetermination of low molecular weight drug molecules and macro-molecules. The quantitative determination leads to the evaluationand interpretation of pharmacokinetic, bioavailability, drug druginteraction, bioequivalence and compatibility studies. Validationof any analytical method ensures that the developed method isreproducible, stable, sensitive, robust, suitable and reliable for itsapplication in blood, plasma, urine, serum and faeces Analysis .

4 Bio-analytical validation ensures the high-quality data for regulatory CDRI communication No. 9211. Corresponding author at: CSIR-Central Drug Research Institute, Lucknow226031, Uttar Pradesh, addresses: Wahajuddin).1 These authors contributed equally to this as well as for the drug discovery and history of bioanalytical method validation was identified glob-ally in 1990, in a workshop sponsored by United States Food andDrug Administration (USFDA) and American Association of Phar-maceutical Sciences (AAPS) with an objective to harmonize themethod validation principles. USFDA released the first guideline forthe bioanalytical method validation in May 2001. National HealthSurveillance Agency (ANVISA), Brazil released its first bioanalyticalguidelines in May 2003 in combination with analytical validationguidelines, which were further amended in May 2012.

5 EuropeanMedicines Agency (EMA, European authority) issued its guidelineswhich became effective since February 2012. Ministry of Health,Labour and Welfare (MHLW), Japan in 2013 issued its draft guid-ance for low molecular weight drugs and bioanalytical method(ligand binding assay) validation in Pharmaceutical there is a general understanding between regulatoryauthorities worldwide on the evaluation of validation parameters,still there are some differences in the methodology and acceptancecriteria employed for bioanalytical method validation . These varia-tions in the guidelines are important for the regulatory submissionin the specific region or country. The present review discusses 2016 Published by Elsevier N. Kadian et al. / Journal of Pharmaceutical and Biomedical Analysis 126 (2016) 83 97most widely followed guidelines for bioanalytical method valida-tion along with their acceptance criteria on different Introduction to the guidelinesUSFDA (2001) bioanalytical method validation guidelines pro-vide assistance to sponsors for Investigational New Drug (IND)Application, New Drug Application (NDA), Abbreviated New DrugApplication (ANDAs) and supplements for development and val-idation of bioanalytical methods used in clinical pharmacology,bioavailability and bioequivalence studies.

6 The guideline is alsoapplicable to the bioanalytical methods used for non-clinicalpharmacology/toxicology studies and preclinical studies in blood,serum, plasma, urine, tissues and skin samples by using gas chro-matography (GC), high-pressure liquid chromatography (HPLC),and combination of GC and LC with mass spectroscopy (MS) suchas GC MS, GC MS/MS, LC MS and LC MS/MS. However, in thecase of veterinary drug approval, the guidance is applicable onlyto blood and urine samples. The draft guidance issued in 2013extended its scope for Biological Licence Application (BLAs) andprovided assistance for developing bioanalytical method validationinformation for biomarker concentration evaluation [1]. The EMAguidance applies to bioanalysis in animal toxicological studies andall phases of clinical trials, along with providing validation recom-mendation for ligand binding assay.

7 EMA kept the methods used forthe quantitative determination of biomarkers in the assessment ofpharmacodynamic endpoints out of its scope [2]. However, if any-one looks closely at the guidelines, then one can easily understandthat the guidelines are basically based on the Good Laboratory Prac-tices (GLP), but still USFDA guidance lacks the recommendation forthe performance of bioanalytical method validation in compliancewith GLP, whereas EMA has recommended performing bioanalyti-cal methods used in non-clinical pharmaco-toxicological studies inagreement with the principles of GLP, but not mandatorily [1 3].Likewise, ANVISA is also limited to the bioanalytical methods usingGC, HPLC and their combination with MS used for the quantitativedetermination of drugs in blood, serum, plasma and urine.

8 ANVISA extended its applicability to other matrices also which has beenlacking in the other guidelines [4]. Its amendment has been pub-lished in 2012, which extended its scope and provided new criteriafor validation of analytical procedure [5]. Japan s MHLW provideda draft for two separate guidelines for small and large molecularweight drugs, respectively and the guidelines are not restricted toa specific detector or analytical technique unlike earlier guidelines[6]. Full validation is recommended by all the regulatory authori-ties for the new chemical entity and when the method is applied forthe first time whether or not mentioned in the literature and alsowhen the metabolites are added to an existing assay for quantifica-tion [1 5]. Additionally, EMA and MHLW guidelines recommend forfull validation for each species and matrix which is seen lacking inthe USFDA guidance [2,6].

9 Partial validation is generally conductedwith an aim to demonstrate the maintenance of the performanceand reliability of the method when minor changes are made toa validated bioanalytical method which includes but not limitedto transferring of method to another laboratory; change in equip-ment, calibration range, limited sample volume, another matrixor species; change in anticoagulant, sample processing procedureetc. The changes should be notified, and also, the partial valida-tion should be justified [1,7,8]. Cross- validation is required for thevalidation parameters when two or more bioanalytical methodsare used to generate data within the same study from differentmethods or different laboratories and across different studies. EMAguides the accuracy to be within 15% and may be wider, if justifiedfor QC samples and the difference between the two values shouldbe within 20% of the mean for at least 67% of the repeats for studysamples [2].

10 MHLW too kept the same criteria with additional con-sideration to intra-and inter-laboratory precision [6]. USFDA andANVISA lack detailed information or acceptance criteria for cross- validation [1,3 5].2. Chromatographic Reference standardsUSFDA draft guidance (2013) in addition to USFDA (2001) guid-ance recommends the characterization of Internal Standard (IS) andanalyte including the certificate of Analysis and in case of expira-tion of IS or reference standard (RS), the stock solution made fromthe expired lot should not be used unless purity is re-established[1,3]. EMA does not recommend the requirement of a certificate ofanalysis for IS-certified standard, as long as it s suitability for use isdemonstrated [2]. MHLW recommends the demonstration of lackof analytical interference with the analyte before the use of IS [6].


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