dc.contributor.author | Atebe, Rogers | |
dc.date.accessioned | 2017-01-06T06:25:05Z | |
dc.date.available | 2017-01-06T06:25:05Z | |
dc.date.issued | 2016 | |
dc.identifier.uri | http://hdl.handle.net/11295/99387 | |
dc.description.abstract | xix
ABSTRACT
Medicines regulatory authorities among developing countries, particularly in Africa, are
increasingly demanding that data on bioequivalence studies should be included when
applying for marketing authorization for some generic products. Generic products for
some of the drug substances for which BE data are demanded include common
substances which have been in use for decades with good safety and efficacy profile. In
addition, biowaiver monographs are available for some of the listed generic
formulations, including Paracetamol immediate release tablets. Studies have been
carried out to demonstrate that a simple mathematical model, the in vitro – in vivo
correlation (IVIVC), can be used to predict bioavailability profile of a drug substance
from in vitro dissolution data. The IVIVC tool has not been put into widespread use in
some parts of the world especially the poorer countries where the greatest benefits would
result, avoiding incurring the high cost of BE studies and reducing generic product
development lead time. This study demonstrated how dissolution data are used to predict
drug bioavailability by employing an IVIVC tool. Generic Paracetamol immediate
release tablets were compared to a registered reference formulation using an IVIVC tool
as a surrogate human bioequivalence studies. Three batches of a generic product, and
one batch comparator product, were subjected to dissolution testing to generate a
dissolution profile. The dissolution profile data were subjected to computation using an
IVIVC tool to predict the blood drug concentration time profile, and specifically
compute the AUC and Cmax values. The AUC and Cmax values obtained for the generic
product and those obtained for the comparator product were subjected to statistical
analysis to evaluate sameness. On this basis, the usefulness in the application of an
IVIVC in generic product development was demonstrated with a possibility of wider
application of this model by the drug regulatory authorities and marketing authorization
(MA) applicants as a justification for biowaiver for generic formulations of candidate
drug substances. | en_US |
dc.language.iso | en | en_US |
dc.publisher | University Of Nairobi | en_US |
dc.rights | Attribution-NonCommercial-NoDerivs 3.0 United States | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/us/ | * |
dc.title | Application of in vitro – in vivo correlation (ivivc) as a predictive tool for bio-equivalence studies for generic paracetamol immediate release tablets. | en_US |
dc.type | Thesis | en_US |
dc.description.department | a
Department of Psychiatry, University of Nairobi, ; bDepartment of Mental Health, School of Medicine,
Moi University, Eldoret, Kenya | |