Bioequivalence Studies and Assessment
Bioequivalence
studies are done for both Early & late Clinical
Trial formulations, Formulations used in clinical trials and stability
studies, if different Clinical trial formulations and to-be-marketed drug
product when it comes to cost and productivity
metrics, it’s often said that what gets measured gets done. Bioequivalence
is determined based on the bioavailability of the innovator medicine versus the
generic
medicine. The outline for bioequivalence study includes the
organization of test and reference items on two events to volunteer subjects,
with every organization isolated by a washout period. This Study involves
parameters on (Cmax) and (AUC), Statistical
evaluation.
Assessment of the bioequivalence
of generic versions of certain reference drugs is complicated by the presence
of endogenous levels of said compounds which cannot be distinguished from
externally derived compound levels following drug administration. If
unaccounted for, the presence of endogenous compound biases towards equivalence
in bioequivalence studies of these drugs. Bioequivalence assessments may be
complicated further as disposition of the exogenous analogue can be subject to
various endogenous
processes resulting in nonlinear pharmacokinetics.
To overcome these inherent biases a number of different strategies have been
employed.
- Pharmaceutical Chemistry and Engineering
- Analytical Techniques in Chemical Engineering
- Pharmaceutical Analytical Chemistry
- Bioequivalence Protocols : In vitro-In vivo correlation
- Dissolution Studies
- Genetic Phenotyping
- Response of clinical studies
For more details: https://drugformulation.pharmaceuticalconferences.com/
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