Clinical Pharmacology Strategy

Using a Pharmacology to Payer Framework to Support Product Development

C. Kirkpatrick, C. Rayner

Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development market failures. As an initial proof of concept, we collaborated with a team of clinical pharmacologists, […]

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Topics: Clinical Pharmacology Strategy

How to Maximize the Benefits of Clinical Pharmacology Gap Analysis

Julie Bullock

Many companies have tried and true clinical pharmacology practices. But when the rubber hits the road for your drug program, will these practices support regulatory success? Has your historic approach to drug development been updated to include the latest modeling and simulation innovations? It’s hard to change how you’ve historically done things. But, do you […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation

Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption

Nikunjkumar Patel

The ability to estimate systemic exposure from dermal absorption is essential in developing new dermatological medications or assessing the toxicological liability of commercially-used chemicals. Historically, animal models were used to evaluate dermal drug absorption prior to clinical testing. However, both differences in human and animal physiology as well as ethical concerns over animal testing have […]

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Topics: PBPK Modeling & Simulation