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C. T. Viswanathan

Bio: C. T. Viswanathan is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Pharmacokinetics & Drug development. The author has an hindex of 11, co-authored 13 publications receiving 5128 citations.

Papers
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Journal ArticleDOI
TL;DR: The purpose of this report is to represent the progress in analytical methodologies over the last decade and assessment of the major agreements and issues discussed with regard to small molecules at both the conference and the workshop.
Abstract: This report is a synthesis of (1) the earlier conference on Analytical Methods Validation−Bioavailability, Bioequivalence and Pharmacokinetic Studies (Conference held in Arlington, VA, December 3–5, 1990 and the report published in Pharmaceutical Research, 9: 588-592, 1992) and (2) the workshop on “Bioanalytical Methods Validation—A Revisit with a Decade of Progress,” (Workshop held in Arlington, VA, January 12–14, 2000), sponsored by the American Association of Pharmaceutical Scientists and the U. S. Food and Drug Administration. The bioanalytical method validation workshop of January 12–14, 2000 was directed towards small molecules. A separate workshop was held in March 1–3, 2000 to discuss validation principles for macromolecules. The purpose of this report is to represent the progress in analytical methodologies over the last decade and assessment of the major agreements and issues discussed with regard to small molecules at both the conference and the workshop. The report is also intended to provide guiding principles for validation of bioanalytical methods employed in support of bioavailability, bioequivalence, and pharmacokinetic studies in man and in animals.

1,588 citations

Journal ArticleDOI
TL;DR: The report presents the assessment of the major agreements and issues discussed at the conference onAnalytical Methods Validation to provide guiding principles for validation of analytical methods used in bioavailability, bioequivalence, and pharmacokinetics studies in humans and animals.

1,220 citations

Journal ArticleDOI
TL;DR: In general, the 3rd AAPS/FDA Bioanalytical Workshop provided a forum to discuss and clarify regulatory concerns regarding bioanalytical method validation issues.
Abstract: The Third AAPS/FDA Bioanalytical Workshop, entitled “Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays” was held on May 1–3, 2006 in Arlington, VA. The format of this workshop consisted of presentations on bioanalytical topics, followed by discussion sessions where these topics could be debated, with the goal of reaching consensus, or identifying subjects where addition input or clarification was required. The discussion also addressed bioanalytical validation requirements of regulatory agencies, with the purpose of clarifying expectations for regulatory submissions. The proceedings from each day were reviewed and summarized in the evening sessions among the speakers and moderators of the day. The consensus summary was presented back to the workshop on the last day and was further debated. This communication represents the distillate of the workshop proceedings and provides the summary of consensus reached and also contains the validation topics where no consensus was reached.

769 citations

Journal ArticleDOI
TL;DR: The report presents the assessment of the major agreements and issues discussed at the conference on analytical methods validation and provides guiding principles for validation of analytical methods used in bioavailability, bioequivalence, and pharmacokinetics studies in humans and animals.
Abstract: 0 This is a summary report of the conference on "Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies." The conference was held from December 3 to 5,1990, in the Washington, D.C., area and was sponsored by the American Association of Pharmaceutical Scientists, the US. Food and Drug Administration, Federation International Pharmaceutique, Health Protection Branch (Canada), and the Association of Official Analytical Chemists. The report presents our assessment of the major agreements and issues discussed at the conference. The report is also intended to provide guiding principles for validation of analytical methods used in bioavailability, bioequivalence, and pharmacokinetics studies in humans and animals. The objectives of the conference were as follows: (1) to reach a consensus on what should be required in analytical methods validation and the procedures to establish validation; (2) to determine processes of application of the validation procedures in bioavailability, bioequivalence, and pharmacokinetics studies; and (3) to develop a report on analytical methods validation that may be referred to in developing future formal guidelines. Acceptable standards for documenting and validating analytical methods with regard to processes, parameters, or data treatments are discussed because of their importance in assessing pharmacokinetic, bioavailability, and bioequivalence studies. Other topics that were considered essential in the conduct of pharmacokinetic studies or in establishing bioequivalency criteria, including measurement of drug metabolites and stereoselective determinations, are also discussed. ___ -. ~. ~ _ _ Analytical methods that are used for the quantitative determination of drugs and their metabolites in biological samples play a significant role in evaluation and interpretation of bioavailability, bioequivalence, and pharmacokinetic data. It is essential to use well-characterized and fully validated analytical methods to yield reliable results that can be satisfactorily interpreted. Analytical methods and techniques are constantly being changed and improved; in many instances, these methods are at the cutting edge of the technology. It is also important to emphasize that each analytical technique has its own characteristics, which will vary from drug to drug. Moreover, the appropriateness of the technique may be influenced by the ultimate objective of the study. Specific validation criteria are needed for methods intended for analysis of each analyte (drug and/or metabolite). Although validation of each method will be independent of those of other methods, there may be situations in which comparison of the methods will be necessary (e.g., when more than one method has been used in a long-term study). When sample analysis is conducted at more than one site, it is necessary to validate the analytical methodb) at each site and provide appropriate validation information for different sites to establish interlaboratory reliability. Unless a method is used on a regular basis, providing confidence in its continued validity, it is essential to document that the method is still valid before analysis of samples in the study. Adequate validation for methods not used on a regular basis often consists of running a standard curve with new quality-control samples to show that the responses, relationship, and general characteristics of the method are similar to previous valida-

582 citations

Journal ArticleDOI
TL;DR: The workshop identified the essential parameters for bioanalytical method validation, ie, accuracy, precision, selectivity, sensitivity, reproducibility, limit of detection, and stability, and resulted in improved quality of data submissions to regulatory agencies.
Abstract: I NTRODUCTION Bioanalysis, employed for the quantitative determination of drugs and their metabolites in biological fl uids, plays a signifi cant role in the evaluation and interpretation of bioequivalence, pharmacokinetic (PK), and toxicokinetic studies. The quality of these studies, which are often used to support regulatory fi lings, is directly related to the quality of the underlying bioanalytical data. It is therefore important that guiding principles for the validation of these analytical methods be established and disseminated to the pharmaceutical community. The fi rst American Association of Pharmaceutical Scientists (AAPS)/Food and Drug Administration (FDA) Bioanalytical Workshop in 1990 focused on key issues relevant to bioanalytical methodology and provided a platform for scientifi c discussions and deliberations. The workshop and the report 1 raised awareness of the need for validated bioanalytical methods for the regulatory acceptance of bioequivalence and pharmacokinetic data. Although the workshop addressed bioanalysis in general, it acknowledged the differences between chromatographic and ligand binding (nonchromatographic based) methods. The workshop identifi ed the essential parameters for bioanalytical method validation, ie, accuracy, precision, selectivity, sensitivity, reproducibility, limit of detection, and stability. The outcome of the fi rst workshop and its report resulted in improved quality of data submissions to regulatory agencies. Following the fi rst workshop report 1 and the experience

465 citations


Cited by
More filters
Journal ArticleDOI
TL;DR: The purpose of this report is to represent the progress in analytical methodologies over the last decade and assessment of the major agreements and issues discussed with regard to small molecules at both the conference and the workshop.
Abstract: This report is a synthesis of (1) the earlier conference on Analytical Methods Validation−Bioavailability, Bioequivalence and Pharmacokinetic Studies (Conference held in Arlington, VA, December 3–5, 1990 and the report published in Pharmaceutical Research, 9: 588-592, 1992) and (2) the workshop on “Bioanalytical Methods Validation—A Revisit with a Decade of Progress,” (Workshop held in Arlington, VA, January 12–14, 2000), sponsored by the American Association of Pharmaceutical Scientists and the U. S. Food and Drug Administration. The bioanalytical method validation workshop of January 12–14, 2000 was directed towards small molecules. A separate workshop was held in March 1–3, 2000 to discuss validation principles for macromolecules. The purpose of this report is to represent the progress in analytical methodologies over the last decade and assessment of the major agreements and issues discussed with regard to small molecules at both the conference and the workshop. The report is also intended to provide guiding principles for validation of bioanalytical methods employed in support of bioavailability, bioequivalence, and pharmacokinetic studies in man and in animals.

1,588 citations

Journal ArticleDOI
TL;DR: Important considerations in analytical method validation will be discussed and may be used as guidance by scientists wishing to develop and validate analytical methods.

1,157 citations

Journal ArticleDOI
TL;DR: The major aspects of matrix effects are discussed with an approach to address matrix effects during method validation proposed.

1,127 citations

Book ChapterDOI
19 Apr 2016

846 citations