Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: Workshop summary report

European Journal of Pharmaceutical Sciences

Volumn 40, Issue 2, 2010, Pages 148-153

  Chen, Mei Ling ^a   Shah, Vinod P ^b   Ganes, Derek ^c   Midha, Kamal K ^d   Caro, James ^e   Nambiar, Prabu ^f   Rocci, Mario L ^g   Thombre, Avinash G ^h   Abrahamsson, Bertil ⁱ   Conner, Dale ^a   Davit, Barbara ^a   Fackler, Paul ^j   Farrell, Colm ^g   Gupta, Suneel ^k   Katz, Russell ^a   Mehta, Mehul ^a   Preskorn, Sheldon H ^l   Sanderink, Gerard ^e   Stavchansky, Salomon ^m   Temple, Robert ^a   Wang, Yaning ^a   Winkle, Helen ^a   Yu, Lawrence ^a   more..

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

^b International Pharmaceutical Federation   (Netherlands)

^c Taro Pharmaceutical   (United States)

^d UNIVERSITY OF SASKATCHEWAN   (Canada)

^e Sanofi Synthelabo Groupe   (United States)

^f VERTEX PHARMACEUTICALS   (United States)

^g ICON Development Solutions   (United States)

^h PFIZER INC   (United States)

ⁱ ASTRAZENECA R AND D   (Sweden)

^j TEVA PHARMACEUTICALS   (Israel)

^k Impax Labs   (United States)

^l UNIVERSITY OF KANSAS   (United States)

^m UNIVERSITY OF TEXAS AT AUSTIN   (United States)

more..

Author keywords

Bioequivalence; Interchangeability; Modified release; Partial area under the curve; Pharmaceutical equivalence; Therapeutic equivalence

Indexed keywords

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL PRACTICE; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG QUALITY; DRUG RELEASE; DRUG RESEARCH; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH SERVICE; PRIORITY JOURNAL; PRODUCT PARAMETERS; QUALITY CONTROL; SENSITIVITY ANALYSIS;

EID: 77952236971     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2010.03.017     Document Type: Article

References (14)

1. Davidson J. Seizures and bupropion: a review. J. Clin. Psychiatry 1989, 50:256-261.
2. Hindmarch I., Legangneux E., Stanley N. A randomized double-blind, placebo-controlled, 10-way cross-over study shows that a new zolpidem modified-release formulation improves sleep maintenance compared to standard zolpidem. Sleep 2004, 27:A55.
3. Preskorn S.H. Should bupropion dosage be adjusted based upon therapeutic drug monitoring?. Psychopharmacol. Bull. 1991, 27:637-643.
4. Roth T., Soubrane C., Titeux L., Walsh J.K. Efficacy and safety of zolpidem-MR: a double-blind, placebo-controlled study in adults with primary insomnia. Sleep Med. 2006, 7:397-406.
5. Swanson J., Gupta S., Guinta D., Flynn D., Agler D., Lerner M., Williams L., Shoulson I., Wigal S. Acute tolerance to methylphenidate in the treatment of attention deficit hypersensitivity disorder in children. Clin. Pharmacol. Ther. 1999, 66:295-305.
6. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs, 2010. Electronic Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed 26.2.10.). http://www.fda.gov/cder/ob/default.htm.
7. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2000. Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. (accessed 26.2.10.). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070246.pdf.
8. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Center for Biologics Evaluation and Research, 2009. Guidance for Industry: Q8(R2) Pharmaceutical Development. (accessed 26.2.10.). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507.pdf.
9. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2003. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. (accessed 26.2.10.). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf.
10. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2007. Individual Product Bioequivalence Recommendation - Zolpidem. (accessed 26.2.10.). In: Draft Guidance for Industry: Bioequivalence Recommendations for Specific Products. (accessed 26.2.10.). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072872.pdf.
11. U.S.Food and Drug Administration Title 21 Code of Federal Regulations (CFR) Part 320.25(f) 2009, Office of Federal Register, National Archives and Records Administration, U.S. Government Printing Office, Washington, DC.
12. U.S.Food and Drug Administration Title 21 Code of Federal Regulations (CFR) Part 320.1 2009, Office of Federal Register, National Archives and Records Administration, U.S. Government Printing Office, Washington, DC.
13. U.S.Food and Drug Administration Title 21 Code of Federal Regulations (CFR) Part 320.24(b) 2009, Office of Federal Register, National Archives and Records Administration, U.S. Government Printing Office, Washington, DC.
14. U.S.Food and Drug Administration Title 21 Code of Federal Regulations (CFR) Part 320.23(b) 2009, Office of Federal Register, National Archives and Records Administration, U.S. Government Printing Office, Washington, DC.