Bioequivalence of indinavir capsules in healthy volunteers
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References
- 1. Wainberg MA. Generic HIV drugs-enlightened policy for global health. N Engl J Med. 2005; 352:747-50.
- 2. Bartlett JA, Muro EP. Generic and branded drugs for the treatment of people living with HIV/AIDS. J Int Assoc Physicians AIDS Care. 2007; 6:15-23.
- 3. Hugen PWH, Burger DM, ter Hofstede HJM, Koopmans PP, Hekster YA. Development of an indinavir oral liquid for children. Am J Health Syst Pharm. 2000; 57:1332-9.
- 4. Yeh KC, Deutsch PJ, Haddix H, Hesney M, Hoagland V, Ju WD, et al. Single-dose pharmacokinetics of indinavir and the effect of food. Antimicrob Agents Chemother. 1998; 42:332-8.
- 5. Hsu A, Granneman GR, Cao G, Carothers L, Japour A, El-Shourbagy T, et al. Pharmacokinetic interaction between ritonavir and indinavir in healthy volunteers. Antimicrob Agents Chemother. 1998; 42:2784-91.
- 6. The United States Pharmacopoeial Convention, Inc. The United States Pharmacopeia 26 / National Formulary 21. Rockville, USA; 2003.
- 7. Drug Control Division. Thailand Guidelines for the Conduct of Bioavailability and Bioequivalence Studies. Bangkok, Thailand: Food and Drug Administration, Ministry of Public Health; 2000.
- 8. Poirier JM, Robidou P, Jaillon P. Determination of indinavir in plasma by solid-phase extraction and column liquid chromatography. Ther Drug Monit. 1999; 21:404-10.
- 9. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). Guidance for Industry, Bioanalytical Method Validation. Available from: http://www.fda.gov/cder/guidance/index.htm, 2001/[2 June 2005].
- 10. Wonnacott RJ, Wonnacott TH, editors. Econometrics. New York:John Wiley & Sons, 1970; p. 132.
- 11. Association of Southeast Asian Nations (ASEAN), Consultative Committee for Standards and Quality- Pharmaceutical Product Working Group. Guidelines for the Conduct of Bioavailability and Bioequivalence Studies. 2004.
- 12. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry. Statistical Approaches to Establishing Bioequivalence. January 2001.
- 13. Kraft WK, McCrea JB, Winchell GA, Carides A, Lowry R, Woolf EJ, et al. Indinavir and rifabutin drug interactions in healthy volunteers. J Clin Pharmacol. 2004; 44:305-13.
10.1177/0091270003262807 - 14. Burger D, Boyd M, Duncombe C, Felderhof M, Mahanontharit A, Ruxrungtham K, et al. Pharmacokinetics and pharmacodynamics of indinavir with or without low-dose ritonavir in HIV-infected Thai patients. J Antimicrob Chemother. 2003; 51:1231-8.
- 15. Schiffman SS, Zervakis J, Heffron S, Heald AE. Effect of protease inhibitors on the sense of taste. Nutrition. 1999; 15:767-72.
10.1016/S0899-9007(99)00152-5
Language: English
Page range: 95 - 101
Published on: Apr 13, 2018
Published by: Chulalongkorn University
In partnership with: Paradigm Publishing Services
Publication frequency: 6 times per year
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© 2018 Suvatna Chulavatnatol, Kumthorn Malathum, Sasisopin Kiertiburanakul, Kittisak Sripha, Pojawon Lawanprasert, published by Chulalongkorn University
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.