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Statistical aspects of bioavailability

Includes bibliography.

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Bibliographic Details
Main Author: Fresen, John Lawrence
Other Authors: Juritz, June M
Format: Thesis
Language:English
Published: Department of Statistical Sciences 2016
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access_status_str Open Access
author Fresen, John Lawrence
author2 Juritz, June M
author_browse Fresen, John Lawrence
Juritz, June M
author_facet Juritz, June M
Fresen, John Lawrence
author_sort Fresen, John Lawrence
collection Thesis
description Includes bibliography.
format Thesis
id oai:open.uct.ac.za:11427/17004
institution University of Cape Town (South Africa)
language eng
last_indexed 2026-06-10T12:34:23.309Z
license_str Not specified — see source repository
provenance_str_mv Harvested via OAI-PMH from UCTD — University of Cape Town Open Access Repository
publishDate 2016
publishDateRange 2016
publishDateSort 2016
publisher Department of Statistical Sciences
publisherStr Department of Statistical Sciences
record_format dspace
source_str UCTD — University of Cape Town Open Access Repository
spelling oai:open.uct.ac.za:11427/17004 Statistical aspects of bioavailability Fresen, John Lawrence Juritz, June M Mathematical Statistics Includes bibliography. In 1984 it became legal for pharmacists to offer customers a cheaper generic alternative for a given prescription. The motivation for this was the excessively high cost of brand name drugs. The substitution of a generic alternative for a brand name drug is based on the assumption that drugs with a comparable chemical composition will have a similar therapeutic effect. The fact that this supposition is not always true has been demonstrated by a number of particular drugs, digoxon being perhaps the most vivid example. The objective of this thesis is to review the statistical aspects associated with (i) measuring the bioavailability of a drug (Chapter 2) (ii) establishing the equivalence of a new and standard formulation of a drug (Chapter 3). In the process of reviewing the literature two problems were identified. Firstly, it is commonly assumed that bioavailability parameters follow either the normal or lognormal distribution. This assumption is difficult to defend, hence procedures based on such assumptions became suspect. Secondly, bioavailability is inherently multivariate whereas in practice univariate procedures are employed. Efren's bootstrap method, which does not rest on assumptions about the underlying distribution, is proposed as a tool for assessing bioequivalence. A new measure of bioequivalence, the Index of Concordance, is proposed. This index can be computed with equal ease for univariate or multivariate data using the bootstrap (Chapter 5). The bootstrap idea of resampling the data can also be applied to compartmental modelling of bioavailability data. One result of this is a nonparametric estimate of the underlying distribution of the bioavailability parameters (Chapter 6). The bootstrap is, on its own, a fascinating concept. A review of the bootstrap is given in Chapter 4. 2016-02-15T07:07:42Z 2016-02-15T07:07:42Z 1985 Master Thesis Masters MSc http://hdl.handle.net/11427/17004 eng application/pdf Department of Statistical Sciences Faculty of Science University of Cape Town
spellingShingle Mathematical Statistics
Fresen, John Lawrence
Statistical aspects of bioavailability
thesis_degree_str Master's
title Statistical aspects of bioavailability
title_full Statistical aspects of bioavailability
title_fullStr Statistical aspects of bioavailability
title_full_unstemmed Statistical aspects of bioavailability
title_short Statistical aspects of bioavailability
title_sort statistical aspects of bioavailability
topic Mathematical Statistics
url http://hdl.handle.net/11427/17004
work_keys_str_mv AT fresenjohnlawrence statisticalaspectsofbioavailability