Search: onr:"swepub:oai:DiVA.org:uu-151831" >
Challenges and oppo...
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)
-
show more...
-
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)
-
show less...
-
(creator_code:org_t)
- Elsevier BV, 2010
- 2010
- English.
-
In: Clinical Therapeutics. - : Elsevier BV. - 0149-2918 .- 1879-114X. ; 32:10, s. 1704-1712
- Related links:
-
https://urn.kb.se/re...
-
show more...
-
https://doi.org/10.1...
-
show less...
Abstract
Subject headings
Close
- 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)
Find in a library
To the university's database
- By the author/editor
-
Chen, Mei-Ling
-
Shah, Vinod P
-
Ganes, Derek
-
Midha, Kamal K
-
Caro, James
-
Nambiar, Prabu
-
show more...
-
Rocci, Mario L
-
Thombre, Avinash ...
-
Abrahamsson, Ber ...
-
Conner, Dale
-
Davit, Barbara
-
Fackler, Paul
-
Farrell, Colm
-
Gupta, Suneel
-
Katz, Russell
-
Mehta, Mehul
-
Preskorn, Sheldo ...
-
Sanderink, Gerar ...
-
Stavchansky, Sal ...
-
Temple, Robert
-
Wang, Yaning
-
Winkle, Helen
-
Yu, Lawrence
-
show less...
- About the subject
-
- MEDICAL AND HEALTH SCIENCES
-
MEDICAL AND HEAL ...
-
and Basic Medicine
-
and Pharmaceutical S ...
- Articles in the publication
-
Clinical Therape ...
- By the university
-
Uppsala University