Clinical Pharmacology Strategy

How Model-informed Drug Development Will Increase R&D Productivity

Suzanne Minton

Will 2017 finally be the year that we overcome the blight of late-stage attrition of promising drug candidates? In a recent commentary, “Improving the Tools of Clinical Pharmacology: Goals for 2017 and Beyond,” in Clinical Pharmacology & Therapeutics, Issam Zineh and colleagues describe several areas where clinical pharmacology approaches can help reduce late-stage attrition and […]

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Topics: Clinical Pharmacology Strategy, Systems Pharmacology

Transforming Drug Product Development the PBPK Way!—A Breakthrough Approach

Shriram Pathak

Developing and optimizing drug formulations― a key component of a product development―is a very lengthy and capital intensive process. Today, most drug candidates are poorly water-soluble; this has led to greater emphasis on screening more complex formulation technologies. Formulation development is still largely an empirical process ― based on trial and error and formulation scientists’ […]

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Topics: PBPK Modeling & Simulation

How MBMA Can Help You Make Smarter Drug Development Decisions

Leon Bax

Successful drug development depends on making wise decisions about portfolios, clinical trials, marketing, etc. We’re continuously faced with the challenge of deciding whether to continue development or stop it. To support those decisions, we gather data, typically through clinical trials. We analyze the data from those clinical trials, and then we use these analyses to […]

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Topics: Model-based Meta-analysis, PK/PD Modeling & Simulation

Leveraging Dissolution Testing to Meet Regulatory Guidelines

Jean-Michel Cardot

Dissolution testing is a standard tool in a formulation scientist’s arsenal. When companies make changes to drug products (particle size, excipients, manufacturing process, equipment, etc), health authorities often require comparing dissolution profiles to determine if the reference and test products are equivalent. Generic drug developers are also required to show bioequivalence between the branded drug […]

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Topics: PK/PD Modeling & Simulation