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
Pioglitazone
Article Details
How to Cite
Assessment of The Bio-Equivalence by Comparing the Single Oral Dose Bioavailability of Pioglitazone Usp Tablets 45 Mg Compare with Reference Product Actos 45mg Tablet in Healthy Adult. (2023). International Journal of Research in Pharmacology & Pharmacotherapeutics, 12(2), 85-92. https://doi.org/10.61096/ijrpp.v12.iss2.2023.85-92
How to Cite
Assessment of The Bio-Equivalence by Comparing the Single Oral Dose Bioavailability of Pioglitazone Usp Tablets 45 Mg Compare with Reference Product Actos 45mg Tablet in Healthy Adult. (2023). International Journal of Research in Pharmacology & Pharmacotherapeutics, 12(2), 85-92. https://doi.org/10.61096/ijrpp.v12.iss2.2023.85-92
References
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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.
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.