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…
Read MorePharmacokinetics (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…
Read MoreThe “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…
Read MoreDrug 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…
Read MorePharmacokinetic (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…
Read MoreFirst-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…
Read MoreAcross 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…
Read MoreIt’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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