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…
Read MorePharmacokinetics & Pharmacodynamics
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…
Read More
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…
Read More
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…
Read More
Metabolites: Formation, Identification, and Impact on Drug Development
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”…
Read More
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…
Read More
Considerations for PK Studies in Pregnant Populations
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,…
Read More