According to the ICH guideline Q1A(R2) adopted by the FDA and EMA, the goal of stability testing is to demonstrate “how the quality of a drug substance or drug product varies with […]

According to the ISO standard 10993, a medical device should be biocompatible i.e. not induce any adverse effects when it comes in contact with the patient. The standard provides a […]

Pharmacokinetic (PK) and Toxicokinetic (TK) analysis is an important aspect of drug development.  These studies may be exploratory in nature or more extensive and formal.  Understanding the bioavailability, exposure, half-life, […]

Recently, there has been much excitement and activity here at Pacific BioLabs regarding the future dedicated stability suite.  This long awaited project, which should be up and running in about […]