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

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

The current regulatory approaches and criteria for bioequivalence evaluation were considered adequate for the assessment of therapeutic equivalence and interchangeability of conventional monophasic MR products. Additional measures may occasionally be needed to establish the bioequivalence of multiphasic MR products, and development of such measures is an important objective. The metric of partial AUC was proposed for products designed to have a rapid drug action followed by sustained response.

Shah, Vinod P (author)
Ganes, Derek (author)
Midha, Kamal K (author)
Caro, James (author)
Nambiar, Prabu (author)
Rocci, Mario L (author)
Thombre, Avinash G (author)
Abrahamsson, BertilUppsala universitet,Institutionen för farmaci(Swepub:uu)berab705 (author)
Conner, Dale (author)
Davit, Barbara (author)
Fackler, Paul (author)
Farrell, Colm (author)
Gupta, Suneel (author)
Katz, Russell (author)
Mehta, Mehul (author)
Preskorn, Sheldon H (author)
Sanderink, Gerard (author)
Stavchansky, Salomon (author)
Temple, Robert (author)
Wang, Yaning (author)
Winkle, Helen (author)
Yu, Lawrence (author)
Uppsala universitetInstitutionen för farmaci (creator_code:org_t)

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Basic Medicine; and Pharmaceutical S ...

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