Main Article Content
Abstract
The present study was open labelled, balanced, randomized, two treatment, two sequence, two period,single dose, cross over comparative oral Bio-equivalence of pioglitazone 45mg tablet study on 16 healthy, adult, human subjects under fasting condition. Test product and treatment with reference drug are done during every period of study. Two-period study is designed over 2 periods with wash out period of 10 days in between and single-dose study because each subject receives only a single dose in each period
Keywords
Article Details
References
- 1. Abdou HM. Dissolution, Bioavailability, Pennsylvania, Mack Publishing Company; 1989.
- 2. ACTOS (pioglitazone hydrochloride) tablet. Daily med current medication information.
- 3. AkulaThukaramBapuji HLVR et al. Bioequivalence testing – industry perspective. J Bioequivalence Bioavailability;2(5).
- 4. Shargel L, wu-Pong S, Andrew BCY. Applied Biopharmaceutics & pharmacokinetics. 5th ed.
- 5. Asian guidelines for ”the conduct of bioavailability and bioequivalence studies”, final draft: 21 July 2004. Adopted from ”note for guidance on the investigation of bioavailability and bioequivalence”, CPMP/EWP. London: European Agency for the Evaluation of Medicinal Products; July 26 2001/QWP/1401/98) with some adaptation for ASEAN application.
- 6. Bioavailability and bioequivalence requirements. Fed Regist. 1977;42:1624- 1653.
- 7. Bioavailability, chapter 8. Bioequivalence, and drug SelectionAuthor: Rasma Chereson reviewer: Umesh Banakar.
- 8. Bioequivalence requirements guidelines. Kingdom of Saudi Arabia: Saudi Food and Drug Authority, Drug Sector [draft]; May 2005.
- 9. Brahmankar DM, Jaiswal SB. Bio pharmaceutics and pharmacokinetics à treatise published by M.K.Jain for wallabhprakashan, printed by goyal offset works, Delhi110088. 1st ed. p. 282-305.
- 10. CDER. Reviewer guidance. Validation Chromatogr Methods. 1994.
- 11. FDA. Guidance for industry. Analytical procedures and methods validation: chemistry, manufacturing, and controls documentation, draft guidance; 2000.
References
1. Abdou HM. Dissolution, Bioavailability, Pennsylvania, Mack Publishing Company; 1989.
2. ACTOS (pioglitazone hydrochloride) tablet. Daily med current medication information.
3. AkulaThukaramBapuji HLVR et al. Bioequivalence testing – industry perspective. J Bioequivalence Bioavailability;2(5).
4. Shargel L, wu-Pong S, Andrew BCY. Applied Biopharmaceutics & pharmacokinetics. 5th ed.
5. Asian guidelines for ”the conduct of bioavailability and bioequivalence studies”, final draft: 21 July 2004. Adopted from ”note for guidance on the investigation of bioavailability and bioequivalence”, CPMP/EWP. London: European Agency for the Evaluation of Medicinal Products; July 26 2001/QWP/1401/98) with some adaptation for ASEAN application.
6. Bioavailability and bioequivalence requirements. Fed Regist. 1977;42:1624- 1653.
7. Bioavailability, chapter 8. Bioequivalence, and drug SelectionAuthor: Rasma Chereson reviewer: Umesh Banakar.
8. Bioequivalence requirements guidelines. Kingdom of Saudi Arabia: Saudi Food and Drug Authority, Drug Sector [draft]; May 2005.
9. Brahmankar DM, Jaiswal SB. Bio pharmaceutics and pharmacokinetics à treatise published by M.K.Jain for wallabhprakashan, printed by goyal offset works, Delhi110088. 1st ed. p. 282-305.
10. CDER. Reviewer guidance. Validation Chromatogr Methods. 1994.
11. FDA. Guidance for industry. Analytical procedures and methods validation: chemistry, manufacturing, and controls documentation, draft guidance; 2000.