EVALUTION OF DOSSIERS IN WHO-PREQUALIFICATION PROJECT MULTISOURCE TB-DRUGS. Evaluation of bioavailability/bioequivalence data Based, with some changes on a presentation by Anna-Karin Hamberg Medical products agency, Sweden Presented by Hans Kemmler Consultant to WHO
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Evaluation of bioavailability/bioequivalence data
Based, with some changes on a presentation by Anna-Karin Hamberg
Medical products agency, Sweden
Consultant to WHO
(Clinical Reviewer, Swissmedic, Switzerland)
intravenous administration = 100% bioavailability
Pharmaceutical equivalence by itself does notnecessarily imply therapeutic equivalence
Could lead to differences in product performance in vivo
Two products are bioequivalent if
Two products are therapeutically equivalent if
If a product is demonstrated to be
therapeutically equivalent to a reference
product, then the products are considered
Quantitative determinations of drugs
in biological samples, such as blood
or plasma, play a significant role in
evaluation and interpretation of
Essential to use a well-characterised
and fully validated analytical method
to yield reliable results.
Closeness of determined value to the true value. The acceptance criteria is mean value 15% deviation from true value. At LOQ, 20% deviation is acceptable.
The closeness of replicate determinations of a sample by an assay. The acceptance criteria is 15% CV. At LOQ, 20% deviation is acceptable.
The limit of quantitation (LOQ) is the lowest concentration which can be measured with acceptable accuracy and precision.
Ability of the method to measure only what it is intended to measure in the presence of other components in the sample. Blank samples of the biological matrix should be tested for interfering peaks.
The extraction efficiency of an analytical process, reported as a percentage of the known amount of an analyte carried through the sample extraction and processing steps of the method. Recovery does not have to be 100%, but the extent of recovery of an analyte and of the internal standard should be consistent.
Stability of the drug in the biological matrix during
the collection process,
the sample storage period and
should be established.
FDA Guidance for Industry
Published Workshop Reports