Cellular and Gene Therapies: What Is My Optimal Dose?
One of the basic tenets of pharmaceutical drug development is the selection of an optimal dose to give to patients. Dose selection is important because too small of a dose…
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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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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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Former FDA Reviewers Provide Answers to Key Questions: Part 2
by Gene Williams and Brian Furmanski Two of Nuventra’s consultants, Gene Williams and Brian Furmanski, spent a combined 23 years working at the FDA. In Part 1 of this blog…
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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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What is Noncompartmental PK Analysis?
Pharmacokinetics (PK) is the branch of pharmacology exploring the effects of the body on a drug. In particular, PK helps us to understand in a quantitative way how a drug…
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