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…
Read MorePharmacokinetics & Pharmacodynamics
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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What is Model-Based Drug Development?
by Scientific Writing Team Model-Based Drug Development (MBDD), sometimes referred to as Model-Informed Drug Development (MIDD), is a process whereby key program decisions are supported by mathematical models and simulations…
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