The use of truncated area under the curves in the bioequivalence evaluation of long half-life drugs: Studies with donepezil and memantine

Arzneimittel-Forschung/Drug Research

Volumn 58, Issue 5, 2008, Pages 255-258

  Erkent, Ülkem ^a   Koytchev, Rossen ^b  

^a Eczacibasi Ilac Pazarlama   (Turkey)

^b Cooperative Clinical Drug Research and Development AG ^*  (Germany)

Author keywords

Bioequivalence, long terminal half life drugs, truncated AUC; CAS 120014 06 4; CAS 19982 08 2; CNS active drugs; Donepezil, bioequivalence; Memantine, bioequivalence

Indexed keywords

CAS 120014 06 4; CAS 19982 08 2; DONEPEZIL; MEMANTINE;

ADULT; ANALYSIS OF VARIANCE; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG HALF LIFE; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE;

EID: 44849144379     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296502     Document Type: Article

References (12)

1. CPMP Note for Guidance on the Investigation of Bioavailability and Bioequivalence. CPMP/EWP/QWP/1401/98, 26 July 2001.
2. FDA Guidance for Industry. Bioavailability and Bioequivalence. Studies for Orally Administered Drug Products - General Considerations. March 2003.
3. Health Canada TPD. Notice to Industry. Bioequivalence Requirements for Long Half-life Drugs. June 2005.
4. NIHS Guideline for Bioequivalence Studies of Generic Products. Japan, December 1997.
5. Physician's Desk Reference (PDR) Information of Aricept®, 2006.
6. Heydorn WE. Donepezil (E2020): a new acetylcholinesterase inhibitor. Review of its pharmacology, pharmacokinetics, and utility in the treatment of Alzheimer's disease. Expert Opin Investig Drugs. 1997 Oct;6(10):1527-1535.
7. Lundback Pharma, Prescribing Information of Ebixa, 2006.
8. ICH Topic E 6. Guideline for Good Clinical Practice. Step 5, Consolidated Guideline from 01.05.1996. Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Jan. 1997.
9. Shah VP, Midha KK, Findlay JWA, Hill HM, Hulse JD, McGilveray IJ, et al. Bioanalytical method validation. A revist with a decade of progress. Pharm Res. 2000;17:1551-1557.
10. FDA Guidance for Industry. Bioanalytical Method Validation. May 2001.
11. Endrenyi L, Tothfalusi L. Truncated AUC evaluates effectively the bioequivalence of drugs with long half-lives. Int J Clin Pharmacol Ther. 1997 Apr;35(4):142-150.
12. Gaudreault J, Potvin D, Lavigne J, Lalonde RL. Truncated area under the curve as a measure of relative extent of bioavailability: evaluation using experimental data and Monte Carlo simulations. Pharm Res. 1998 Oct;15(10):1621-1629.