Pharmacodynamic bioequivalence testing

Journal of Clinical Pharmacy and Therapeutics

Volumn 37, Issue 5, 2012, Pages 497-498

  Li, S ^a  

^a IQVIA   (United States)

Author keywords

bioequivalence; highly variable drug; locally acting drug; pharmacodynamics; pharmacokinetics

Indexed keywords

ACARBOSE; GLUCOSE; OLIGOSACCHARIDE;

ABSORPTION; AREA UNDER THE CURVE; BIOEQUIVALENCE; CONFIDENCE INTERVAL; CONTROLLED STUDY; DIABETES MELLITUS; DRUG ABSORPTION; DRUG CONCENTRATION; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; GLUCOSE BLOOD LEVEL; HUMAN; IN VITRO STUDY; MAXIMUM PLASMA CONCENTRATION; REVIEW; TABLET;

ACARBOSE; HUMANS; MALE;

EID: 84865864064     PISSN: 02694727     EISSN: 13652710     Source Type: Journal    
DOI: 10.1111/j.1365-2710.2012.01338.x     Document Type: Review

References (10)

1. Lionberger RA,. FDA critical path initiatives: opportunities for generic drug development. AAPS J, 2008; 10: 103-109.
2. US Food and Drug Administration. Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations, 2003.
3. European Medicines Agency. Guideline on the Investigation of Bioequivalence, 2010.
4. Lee S, Chung JY, Hong KS, et al. Pharmacodynamic comparison of two formulations of Acarbose 100-mg tablets. J Clin Pharm Ther, 2012; 37: 553-557.
5. Coniff RF, Shapiro JA, Robbins D, Kleinfield R, Seaton TB, Beisswenger P, McGill JB,. Reduction of glycosylated hemoglobin and postprandial hyperglycemia by acarbose in patients with NIDDM. A placebo-controlled dose-comparison study. Diabetes Care, 1995; 18: 817-824.
6. Bayer HealthCare Pharmaceuticals Inc. PRECOSE® (acarbose tablets), 2008.
7. Ahr HJ, Boberg M, Krause HP, et al. Pharmacokinetics of acarbose. Part I: absorption, concentration in plasma, metabolism and excretion after single administration of [14C]acarbose to rats, dogs and man. Arzneimittelforschung, 1989; 39: 1254-1260. (Pubitemid 19255301)
8. US Food and Drug Administration. Draft guidance on acarbose, 2009.
9. Haidar SH, Davit B, Chen ML, et al. Bioequivalence approaches to highly variable drugs and drug products. Pharm Res, 2008; 25: 237-241.
10. Haidar SH, Makhlouf F, Schuirmann DJ, Hyslop T, Davit B, Conner D, Yu LX,. Evaluation of a scaling approach for the bioequivalence of highly variable drugs. AAPS J, 2008; 10: 450-454.