Design and analysis of bioavailability and bioequivalence studies pdf

What are the methods for assessing bioavailability and bioequivalence?
Measurement of drug concentrations in blood, plasma, or serum after drug administration is the most direct and objective way to determine systemic drug bioavailability..
What is the design of a bioequivalence trial?
Standard bioequivalence studies generally use a crossover design.
Because drug clearance typically shows large between-subject variabilities, analyzing pharmacokinetic results for two products within the same subject is usually more powerful..
In bioequivalence studies, the molar equivalent dose of each product should be used.
The lots for comparative bioavailability testing should be taken from a batch that is comparable in size and is produced using the same type of equipment and procedures proposed for the market.
In general, a bioequivalence study should be conducted under fasting conditions as this is considered to be the most sensitive condition to detect a potential difference between formulations.
Standard bioequivalence studies generally use a crossover design.
Because drug clearance typically shows large between-subject variabilities, analyzing pharmacokinetic results for two products within the same subject is usually more powerful.

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