Intrinsic and Extrinsic Factors in Drug Development
Personalized medicine (also known as precision medicine) is one of today’s biggest drug development buzzwords. It certainly stirs the imagination – the notion that one day we may live in…
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FDA Policies to Accelerate Development of Cell & Gene Therapies
FDA Commissioner Scott Gottlieb, M.D. and Director of the Center for Biologics Evaluation and Research (CBER) Peter Marks, M.D., Ph.D., released a joint statement on January 15, 2019 previewing new FDA…
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Pharmacokinetic Considerations for Topically Applied Drugs
A topically applied drug is any medication that is applied to the body’s surface (e.g., skin, eyes) in order to achieve a desired local therapeutic effect. Many drug types fall under…
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The Path to IND Part 2: Supporting Clinical Study Design and Dosing
Introduction In part one of this blog series, “The Path to IND Part I: Milestones and Common Roadblocks,” we introduced the FDA’s Investigational New Drug (IND) application and highlighted some…
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What is Population Pharmacokinetic (popPK) Analysis?
Population pharmacokinetics (popPK) is the study of variability in drug concentrations within a patient population receiving clinically relevant doses of a drug of interest. PopPK methods use mathematical models to describe…
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The Path to IND Part 1: Milestones & Common Roadblocks
The Investigational New Drug (IND) application is the primary pathway through which new drugs and biologics are approved to be tested in humans. But, what exactly is an IND and…
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Why Do Clinical Trials Fail?
by Scientific Writing Team Large quantities of time, money, and intellectual capital are expended to plan and execute clinical trials. Yet, despite all of these investments, clinical trials don’t always…
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