The 2nd calibration and validation group workshop on recent issues in Good Laboratory Practice bioanalysis

Bioanalysis

Volumn 1, Issue 1, 2009, Pages 19-30

  Savoie, Natasha ^a   Booth, Brian P ^b   Bradley, Troy ^a   Garofolo, Fabio ^a   Hughes, Nicola C ^c   Hussain, Saleh ^d   King, S Peter ^e   Lindsay, Michael ^f   Lowes, Steve ^g   Ormsby, Eric ^h   Phull, Rupinder ⁱ   Rocci Jr, Mario L ^j   Vallano, Patrick T ^k   Viau, Alan ^h   Zhu, Zhimeng ^a  

^a INSTITUTE FOR RESEARCH IN IMMUNOLOGY AND CANCER   (Canada)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c Biovail Contract Research   (Canada)

^d Anapharm Inc   (Canada)

^e Quest Pharmaceutical Services   (United States)

^f Apotex Inc   (Canada)

^g Advion BioSciences Inc   (United States)

^h HEALTH CANADA   (Canada)

ⁱ Barr Pharmaceuticals Inc   (United States)

^j ICON PLC   (United Kingdom)

^k Formulation Development Services   (India)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ARTICLE; BIOAVAILABILITY; BIOTRANSFORMATION; CALIBRATION; DRUG CONTAMINATION; DRUG STORAGE; FOOD AND DRUG ADMINISTRATION; HUMAN; LABORATORY; METABOLISM; PHARMACOKINETICS; QUALITY CONTROL; REPRODUCIBILITY; STANDARD; UNITED STATES;

BIOLOGICAL AVAILABILITY; BIOTRANSFORMATION; CALIBRATION; DRUG CONTAMINATION; DRUG STORAGE; HUMANS; LABORATORIES; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79951768879     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.09.11     Document Type: Conference Paper

References (10)

1. Garofolo F. Bioanalytical Method Validation. In: Analytical Method Validation and Instrument Performance Verifcation. Chan CC, Lee YC, Lam H, Zhang X (Eds), Hoboken: John Wiley & Sons, Inc., West Sussex, UK, Chapter 8 (2004).
2. Shah VP. the history of bioanalytical method validation and regulation: evolution of a guidance document on bioanalytical method validation. AAPS J. 9(1), E43-E47 (2007).
3. Shah VP, Midha KK, Dighe SV et al. Analytical methods validation: bioavailability, bioequivalence and pharmaceutical studies. Pharm. Res. 9, 588-592 (1992).
4. US Food and Drug Administration. Draft Guidance for Industry: Bioanalytical Method Validation. US Food and Drug Administration, Rockville, MD, USA (1999).
5. Shah VP, Midha KK, Findlay JW et al. Bioanalytical method validation-a revisit with a decade of progress. Pharm. Res. 17, 1551-1557 (2000).
6. US Food and Drug Administration. Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Rockville, MD, USA (2001).
7. Viswanathan CT, Bansal S, Booth B et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Workshop/Conference Report. AAPS J. 9(1), E30-E42 (2007).
8. US Food and Drug Administration. Guidance for Industry: Investigating Out-Of-Specifcation (OOS) Test Results for Pharmaceutical Production. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Rockville, MD, USA (2006).
9. ANVISA. Manual for Good Bioavailability and Bioequivalence Practices. Brazilian Sanitary Surveillance Agency, Brazil (2002).
10. Rocci ML Jr, Devanarayan V, Haughey DB, Jardieu P. Confrmatory reanalysis of incurred bioanalytical samples. AAPS J. 9(3), E336-E343 (2007).