dc.contributor.author | Njue, Catherine | |
dc.date.accessioned | 2013-06-18T07:02:48Z | |
dc.date.available | 2013-06-18T07:02:48Z | |
dc.date.issued | 2011 | |
dc.identifier.citation | Volume 39, Issue 5, September 2011, Pages 266–269 | en |
dc.identifier.uri | http://www.sciencedirect.com/science/article/pii/S1045105611000716 | |
dc.identifier.uri | http://erepository.uonbi.ac.ke:8080/xmlui/handle/123456789/35321 | |
dc.description.abstract | For the purpose of comparing the efficacy and safety of a Similar Biotherapeutic Product (SBP) to a Reference Biotherapeutic Product (RBP), the “Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)” issued by the World Health Organisation (WHO), states that equivalence or non-inferiority studies may be acceptable. While in principle, equivalence trials are preferred, non-inferiority trials may be considered if appropriately justified, such as for a medicinal product with a wide safety margin. However, the statistical issues involved in the design, conduct, analysis and interpretation of equivalence and non-inferiority trials are complex and subtle, and require that all aspects of these trials be given careful consideration. These issues are important in order to ensure that equivalence and non-inferiority trials provide valid data that are necessary to draw reliable conclusions regarding the clinical similarity of an SBP to an RBP. | en |
dc.language.iso | en | en |
dc.title | Statistical considerations for confirmatory clinical trials for similar biotherapeutic products | en |
dc.type | Article | en |
local.publisher | College of Physical and Biological Sciences | en |