Pacific BioLabs (PBL) is pleased to announce the launch of In Vitro Services offering in vitro, cell-based assays supporting the pharmaceutical, biopharma, and medical device industries. The addition of this […]

The United States Pharmacopeia (USP) has published a new general chapter, the USP <60> which will become official on December 1, 2019. The chapter specifies tests to determine the presence […]

The SciEx TripleTOF 5600 Mass Spectrometer is known for delivering excellent sensitivity and linear dynamic range. In highly complex matrices, the TripleTOF 5600 provides high-resolution of low- abundance analytes which is just […]

With the prevalence of diabetes increasing worldwide at unprecedented rates in recent decades, the development of relevant drug therapies have expanded as well. Medications for regulating blood glucose levels are […]

Systems used to package therapeutics products – often called “Packaging Systems”, are generally constructed and composed from materials that may include glass, metals, plastics and elastomers/homologous polymers with a range […]

Current FDA guidance indicates that drug interactions should be "defined during drug development, as part of an adequate assessment of the drug's safety and effectiveness." 1 While in vivo drug interaction studies […]

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 […]

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, […]

As part of their effort to provide clearer directions for industry, the FDA recently published a new guidance document for ICH Q8, Q9, and Q10.This document is taken […]

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 […]