Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations

AAPS Journal

Volumn 14, Issue 4, 2012, Pages 925-926

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

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Attention deficit hyperactivity disorder; Bioequivalence; Generic drugs; Methylphenidate; PAUC

Indexed keywords

METHYLPHENIDATE;

AREA UNDER THE CURVE; ARTICLE; ATTENTION DEFICIT DISORDER; BIOEQUIVALENCE; DRUG ABSORPTION; DRUG EXPOSURE; DRUG FORMULATION; DRUG HALF LIFE; DRUG RELEASE; HUMAN; MAXIMUM PLASMA CONCENTRATION; TIME TO MAXIMUM PLASMA CONCENTRATION;

AREA UNDER CURVE; CENTRAL NERVOUS SYSTEM STIMULANTS; CLINICAL TRIALS AS TOPIC; DELAYED-ACTION PREPARATIONS; DRUGS, GENERIC; HUMANS; METHYLPHENIDATE; THERAPEUTIC EQUIVALENCY;

EID: 84869119658     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9397-7     Document Type: Article

References (10)

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/Guidance ComplianceRegulatoryInformation/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/drug Info.cfm?id=34566&CFID=104324036&CFTOKEN=7817fd5a1e259439-F14B296D-C81B- A59C-8039A19C3CD27924 &jsessionid=84302ca9d80b916d533411 6f7a46145b4247. Accessed 23 Jan 2012.
5. Draft Guidance on Methylphenidate Hydrochloride. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM281454. pdf. Accessed 23 Jan 2012.
6. FDA Meeting of the Advisory Committee for Pharmaceutical Sciences and Clinical Pharmacology. http://www.fda.gov/down loads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ AdvisoryCommitteeforPharmaceuticalScienceandClinical Pharmacology/UCM207955.pdf. Accessed 23 Jan 2012
7. Swanson J, Kinsbourne M, Roberts W, Zucker K. Time-response analysis of the effect of stimulant medication on the learning ability of children referred for hyperactivity. Pediatrics. 1978;61 (1):21-9.
8. Swanson JM, Wigal SB, Wigal T, Sonuga-Barke E, Greenhill LL, Biederman J, et al. A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the Comacs Study). Pediatrics. 2004;113(3 Pt 1):e206-16.
9. Chen ML, Davit B, Lionberger R, Wahba Z, Ahn HY, Yu LX. Using partial area for evaluation of bioavailability and bioequivalence. Pharm Res. 2011;28(8):1939-47.
10. Ritalin Label. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm? id=34832. Accessed 23 Jan 2012