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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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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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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by Scientific Writing Team Much of the drug development process focuses on characterizing the activity and safety profile of the drug substance (i.e., the active pharmaceutical ingredient [API] or “parent”…
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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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by Scientific Writing Team Most pharmacokinetics (PK) clinical studies, and most clinical studies in general, exclude pregnant women in order to protect the safety of the mother and fetus. Furthermore,…
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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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