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

Chen, Mei-Ling (author)
Shah, Vinod P (author)
Ganes, Derek (author)
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Midha, Kamal K (author)
Caro, James (author)
Nambiar, Prabu (author)
Rocci, Mario L (author)
Thombre, Avinash G (author)
Abrahamsson, Bertil (author)
Uppsala universitet,Institutionen för farmaci
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)
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 (creator_code:org_t)
Elsevier BV, 2010
2010
English.
In: Clinical Therapeutics. - : Elsevier BV. - 0149-2918 .- 1879-114X. ; 32:10, s. 1704-1712
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • 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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)

Keyword

PHARMACY
FARMACI

Publication and Content Type

ref (subject category)
art (subject category)

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