What is Pharmacokinetics and ADME?
Pharmacokinetics (PK) is the study of how a drug moves throughout the body and provides important information on the systemic exposure to the drug over time. Conversely, pharmacodynamics (PD) describes…
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Understanding How PK Data and CDISC Work Together
The “Clinical Data Interchange Standards Consortium” (CDISC) is a not-for-profit organization that develops data standards for drug development. CDISC works with global regulatory agencies to develop guidelines and requirements that…
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Common Clinical Pharmacology Mistakes to Avoid in Drug Development
Drug development is a complex process where clinical pharmacology data must be generated to support regulatory approval and marketing authorization. Each drug program has unique challenges and special circumstances, but…
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Compartmental Modeling in Pharmacokinetics
Pharmacokinetic (PK) modeling is a tool used to help drug developers understand a drug’s effects on the body by analyzing its absorption, distribution, metabolism, and excretion (ADME) properties. These effects…
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Determining First-in-Human (FIH) Dose for Clinical Studies
First-in-Human (FIH) studies are designed and conducted based on nonclinical data submitted to and reviewed by regulatory authorities. For the very first trial in humans, nonclinical toxicology, pharmacology, pharmacokinetics, in…
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FDA Project Optimus: Selecting the Optimal Dose for Oncology Therapeutics
Across the spectrum of therapeutic indications, typically, the majority of new investigational drugs are evaluated in randomized dose-ranging clinical trials. These types of clinical trials enable a reasonable understanding of…
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How to Form a Clinical Pharmacology Strategy for your NDA, BLA, or MAA
It’s common knowledge that every approved drug on a pharmacy shelf must undergo extensive testing to demonstrate safety and efficacy. However, there is much more that goes into the approval…
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