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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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 the Difference Between PBPK and PopPK Modeling?
by Scientific Writing Team “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…
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The Importance of Clinical Trial Monitoring and Data Management for Population PK Modeling
What are some of the most common and costly mistakes sponsors make when it comes to collection of pharmacokinetic (PK) samples in clinical studies? In this post, we will discuss…
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Is a Renal Impairment Study Needed for NDA or BLA Approval?
Renal Impairment Studies for FDA Approval – Common Questions and Answers Is a renal impairment study needed for your drug development program and NDA/BLA? The answer depends on a lot…
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