CDER Guidances for Nonclinical Toxicology to Issue in 2012

The FDA has published an updated Guidance Agenda – new and revised draft guidances CDER is planning to publish during calendar year 2012.   Guidances of particular interest to nonclinical pharmaceutical toxicologists may include: Pharmacology/Toxicology •...

High-throughput ADME Screening Technologies

High throughput (HT) Absorption, Distribution, Metabolism, and Excretion (ADME) screening technology is the current push from Big Pharma to be outsourced through contract research organizations (CROs).  Shifting also is the ADME regulatory emphasis; the FDA has...

Dried Blood Spot Analysis: Preclinical Pros and Cons

Both advantages and challenges exist for use of dried blood spots during preclinical drug development.   Advantages include small sample volumes coupled with easy shipment and storage.  The amount of blood per spot varies (10 to 100 μL), but use of 15 to 20 μL seems...

Drug Pharmacokinetic Comparison between Humans and Monkeys

To verify the availability of pharmacokinetic parameters in cynomolgus monkeys, hepatic availability (Fh) and the fraction absorbed (Fa) multiplied by intestinal availability (Fg) were evaluated to determine their contributions to absolute bioavailability (F) after...