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PharmD clinical pharmacy program Level 3, Semester 2 Biopharmaceutics & Pharmacokinetics (PT608(

Performance of drug products: in vitro–in vivo

correlation

In vitro: dissolution and drug release testing

 Dissolution and drug release tests are in vitro tests that measure the rate and extent
of dissolution or release of the drug substance from a drug product, usually in an

aqueous medium under specified conditions.
 In vitro dissolution testing provides useful information throughout the drug

development process.
 The dissolution test is an important quality control procedure used to confirm batch-

to-batch reproducibility and to show typical variability in composition and

manufacturing parameters.

 Dissolution and drug release tests are also used as a measure of drug product

performance, in vitro when linked to product performance in vivo. The dissolution test

should reflect relevant changes in the drug product formulation or changes in the

manufacturing process that might affect drug release characteristics and consequently

in vivo performance.

Typical setup for performing the USP dissolution
test

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