Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations

Author:

Stier Ethan M.,Davit Barbara M.,Chandaroy Parthapratim,Chen Mei-Ling,Fourie-Zirkelbach Jeanne,Jackson Andre,Kim Stephanie,Lionberger Robert,Mehta Mehul,Uppoor Ramana S.,Wang Yaning,Yu Lawrence,Conner Dale P.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference10 articles.

1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products–General Considerations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf . Accessed 23 Jan 2012.

2. Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology April 13, 2010 Briefing Information. http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3804t2_03_Afternoon_Session.pdf . Accessed 23 Jan 2012

3. Chen ML, Shah VP, Ganes D, Midha KK, Caro J, Nambiar P, et al. Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report. AAPS J. 2010;12(3):371–7.

4. Ritalin LA Label. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=34566&CFID=104324036&CFTOKEN=7817fd5a1e259439-F14B296D-C81B-A59C-8039A19C3CD27924&jsessionid=84302ca9d80b916d5334116f7a46145b4247 . Accessed 23 Jan 2012.

5. Draft Guidance on Methylphenidate Hydrochloride. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM281454.pdf . Accessed 23 Jan 2012.

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