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 (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...
Both advantages and challenges exist for use of dried blood spots during preclinical drug development. سلوتس اون لاين 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 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...
