505(b)(2) Expertise In Clinical Pharmacology

Critical Role of PK Modeling & Simulation

The role of clinical pharmacology in drug approvals via the 505(b)(2) pathway primarily includes (but is not limited to): evaluating the extent of the Sponsor’s clinical pharmacology program and the potential need for additional or supportive pharmacokinetic (PK) or clinical pharmacology information; assessment of the most appropriate information source(s) for data reliance and how the information can be leveraged; designing of PK bioavailability/bioequivalence (BA/BE) study(s) or the rationale for biowaivers.

Clinical pharmacology assessments include mechanism of action (MOA), absorption, distribution, metabolism, and excretion (ADME), PK, pharmacodynamics (PD), drug-drug interactions (DDI), and special populations. In a typical 505(b)(2) program, Sponsors can rely on the Agency’s previous findings of efficacy and/or safety of an FDA approved drug upon establishing a successful PK bridge in a pivotal BA/BE study. The PK bridging BA/BE study is designed to investigate the exposure of either a new formulation or new route of administration for an active pharmaceutical ingredient (API) compared to the exposure of an FDA approved product(s) containing the same API.

Importantly, any differences in BA compared to a reference product typically must be supported by additional clinical trials or appropriate justification.  Furthermore, additional clinical pharmacology studies may be required to characterize new dosage forms or older repurposed drugs properly.

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