caa a22 4500 445801050 CHVBK 20180317145141.0 cr unu---uuuuu 170323e20110201xx s 000 0 eng 10.1007/s10337-010-1869-2 doi (NATIONALLICENCE)springer-10.1007/s10337-010-1869-2 International Guidelines for Bioanalytical Method Validation: A Comparison and Discussion on Current Scenario [Elektronische Daten] [Sivacharan Kollipara, Girish Bende, Nitin Agarwal, Brijesh Varshney, Jyoti Paliwal] US FDA released guidelines for bioanalytical method validation in 2001 and it became the basis for guidelines such as ANVISA and EMA. Even though there is a general agreement between these guidelines in terms of evaluation of validation parameters, significant diversity exists with respect to methodology employed. Present review compares and summarizes the regulatory guidelines issued by US FDA, ANVISA and EMA for bioanalytical method validation. This review also discusses evaluation of certain validation parameters such as matrix effect, incurred sample reanalysis, various stability aspects, effect of anticoagulant counter ions, specificity in the presence of concomitant medications, and identification of pharmacokinetic repeats wherein specific guidance and general consensus amongst scientific community does not exist. Springer-Verlag, 2011 Bioanalysis nationallicence Validation nationallicence US FDA nationallicence ANVISA nationallicence EMA nationallicence Regulatory guidance nationallicence AAPS : American Association of Pharmaceutical Scientists nationallicence ANVISA : The National Health Surveillance Agency nationallicence CC : Calibration curve nationallicence CV : Coefficient of variation nationallicence CVG : Calibration and validation group nationallicence DL : Detection limit nationallicence DoE : Design of experimentation nationallicence EDTA : Ethylenediaminetetraacetic acid nationallicence EMA : European Medicines Agency nationallicence GLP : Good Laboratory Practices nationallicence HQC : Higher quality control sample nationallicence IS : Internal Standard nationallicence ISR : Incurred Sample Reanalysis nationallicence LOD : Limit of detection nationallicence LOQ : Limit of quantification nationallicence LLOQ : Lower limit of quantification nationallicence LLOQQC : Quality control sample at lower limit of quantification nationallicence MF : Matrix factor nationallicence MQC : Middle quality control sample nationallicence QC : Quality control sample nationallicence RSD : Residual standard deviation nationallicence ULOQ : Upper limit of quantification nationallicence US FDA : United States Food and Drug Administration nationallicence Kollipara Sivacharan Metabolism and Pharmacokinetics Department, Ranbaxy Research Laboratories, Plot No. 20, Sector-18, Udyog Vihar Industrial Area, 122015, Gurgaon, Haryana, India aut Bende Girish Formulation Development and Pharmacokinetics Laboratory, Pharmacy Group, Birla Institute of Technology and Science, 333031, Pilani, Rajasthan, India aut Agarwal Nitin Metabolism and Pharmacokinetics Department, Ranbaxy Research Laboratories, Plot No. 20, Sector-18, Udyog Vihar Industrial Area, 122015, Gurgaon, Haryana, India aut Varshney Brijesh Metabolism and Pharmacokinetics Department, Ranbaxy Research Laboratories, Plot No. 20, Sector-18, Udyog Vihar Industrial Area, 122015, Gurgaon, Haryana, India aut Paliwal Jyoti Metabolism and Pharmacokinetics Department, Ranbaxy Research Laboratories, Plot No. 20, Sector-18, Udyog Vihar Industrial Area, 122015, Gurgaon, Haryana, India aut Chromatographia Vieweg Verlag 73/3-4(2011-02-01), 201-217 0009-5893 73:3-4<201 2011 73 10337 https://doi.org/10.1007/s10337-010-1869-2 text/html Onlinezugriff via DOI 1 review-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s10337-010-1869-2 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Kollipara Sivacharan Metabolism and Pharmacokinetics Department, Ranbaxy Research Laboratories, Plot No. 20, Sector-18, Udyog Vihar Industrial Area, 122015, Gurgaon, Haryana, India aut NATIONALLICENCE 700 1- Bende Girish Formulation Development and Pharmacokinetics Laboratory, Pharmacy Group, Birla Institute of Technology and Science, 333031, Pilani, Rajasthan, India aut NATIONALLICENCE 700 1- Agarwal Nitin Metabolism and Pharmacokinetics Department, Ranbaxy Research Laboratories, Plot No. 20, Sector-18, Udyog Vihar Industrial Area, 122015, Gurgaon, Haryana, India aut NATIONALLICENCE 700 1- Varshney Brijesh Metabolism and Pharmacokinetics Department, Ranbaxy Research Laboratories, Plot No. 20, Sector-18, Udyog Vihar Industrial Area, 122015, Gurgaon, Haryana, India aut NATIONALLICENCE 700 1- Paliwal Jyoti Metabolism and Pharmacokinetics Department, Ranbaxy Research Laboratories, Plot No. 20, Sector-18, Udyog Vihar Industrial Area, 122015, Gurgaon, Haryana, India aut NATIONALLICENCE 773 0- Chromatographia Vieweg Verlag 73/3-4(2011-02-01), 201-217 0009-5893 73:3-4<201 2011 73 10337 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer