How critical is the duration of the sampling scheme for the determination of half-life, characterization of exposure and assessment of bioequivalence?

Journal of Pharmacy and Pharmaceutical Sciences

Volumn 14, Issue 2, 2011, Pages 217-226

  Colucci, Philippe ^a,b   Turgeon, Jacques ^a,c   Ducharme, Murray P ^a,b  

^a UNIVERSITÉ DE MONTRÉAL   (Canada)

^b Cetero Research   (United States)

^c CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG DETERMINATION; DRUG ELIMINATION; DRUG HALF LIFE; MATHEMATICAL ANALYSIS; MATHEMATICAL COMPUTING; SAMPLING ERROR; SIMULATION;

EID: 79959317857     PISSN: None     EISSN: 14821826     Source Type: Journal    
DOI: 10.18433/j3fg63     Document Type: Article

References (11)

1. Bioavailability and bioequivalence requirements. Code of Federal Regulations Title 21, Volume 5, Pt. 320.1. Revised April 1, 2009. Access May 6, 2010.
2. Niazi, S.K. Handbook of bioequivalence testing. Informa Healthcare, New York, NY, 2007.
3. Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products - general considerations. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). March 2003.
4. Gibaldi M and Perrier D. Pharmacokinetics. 2nd ed (revised and expanded). Informa Healthcare, New York, NY, 2007.
5. Purves RD. Bias and variance of extrapolated tails for area-under-the-curve (AUC) and area-underthe- moment-curve (AUMC). J Pharmacokinet Biopharm. 1992 Oct;20(5):501-10.
6. D'Argenio, D.Z., A. Schumitzky and X. Wang. ADAPT 5 User's Guide: Pharmacokinetic/Pharmacodynamic Systems Analysis Software. Biomedical Simulations Resource, Los Angeles, 2009.
7. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 1981 Aug;9(4):503-12.
8. Guidance for Industry. Conduct and analysis of bioavailability and bioequivalence studies - Part A: Oral dosage formulations used for systemic effects. Canada Health Products and Food Branch Guidance Document. 1992.
9. Draft guideline on the investigation of bioequivalence. European Medicines Agency; Committee for Medicinal Products for Human use (CHMP). London, 24 July 2008.
10. Riegelman S, Collier P. The application of statistical moment theory to the evaluation of in vivo dissolution time and absorption time. J Pharmacokinet Biopharm. 1980 Oct;8(5):509-34.
11. Purves RD. Numerical estimation of the noncompartmental pharmacokinetic parameters variance and coefficient of variation of residence times. J Pharm Sci. 1994 Feb;83(2):202-5.