Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report.
2010 (English)In: Clinical Therapeutics, ISSN 0149-2918, E-ISSN 1879-114X, Vol. 32, no 10, 1704-1712 p.Article in journal (Refereed) Published
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.
Place, publisher, year, edition, pages
2010. Vol. 32, no 10, 1704-1712 p.
IdentifiersURN: urn:nbn:se:uu:diva-151831DOI: 10.1016/j.clinthera.2010.09.014PubMedID: 21194592OAI: oai:DiVA.org:uu-151831DiVA: diva2:411419