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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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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Lessons from FDA’s Grand Rounds: “How Simulation Can Transform Regulatory Pathways”
Modeling and simulation are transforming how drugs are developed and how they are regulated. This is the conclusion from a recent FDA Grand Rounds presentation entitled “How Simulation can Transform…
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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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Understanding the Value of a Gap Analysis in Drug Development
Today, the cost of developing a new drug is higher than ever, driven in large part by improperly designed, untimely, or unnecessary clinical studies. Companies pour money into a development…
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What is the Difference Between PBPK and PopPK Modeling?
“I suppose it is tempting, if the only tool you have is a hammer, to treat everything as if it were a nail.” – Abraham Maslow Modeling is an indispensable…
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