Microbiology, Pharmaceuticals
Burkholderia cepacia and the new USP <60>
The United States Pharmacopeia (USP) has published a new general chapter, the USP <60> which will become official on December […]
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Analytical Chemistry, Biologics, Medical Device, Pharmaceuticals
Pacific BioLabs Purchases SciEx TripleTOF 5600 High Resolution Mass Spec System
The SciEx TripleTOF 5600 Mass Spectrometer is known for delivering excellent sensitivity and linear
dynamic range. In highly complex matrices, the […]
Biologics, Medical Device, Pharmaceuticals
Insulin and Glucagon Bioassays
With the prevalence of diabetes increasing worldwide at unprecedented rates in recent decades, the development of relevant drug therapies have […]
Medical Device, Pharmaceuticals
USP 661 Plastic Packaging: Introduction to <661.1> and <661.2>
Systems used to package therapeutics products – often called “Packaging Systems”, are generally constructed and composed from materials that may […]
Analytical Chemistry, Pharmaceuticals
CASE STUDY : CHALLENGES IN METHOD DEVELOPMENT FOR DRUG INTERACTION STUDIES
Current FDA guidance indicates that drug interactions should be "defined during drug development, as part of an adequate assessment of the […]
Analytical Chemistry, Pharmaceuticals
What is Stability Testing?
According to the ICH guideline Q1A(R2) adopted by the FDA and EMA, the goal of stability testing is to demonstrate “how the […]
Analytical Chemistry, Pharmaceuticals
PK Studies at PBL
Pharmacokinetic (PK) and Toxicokinetic (TK) analysis is an important aspect of drug development. These studies may be exploratory in nature […]
News, Pharmaceuticals
Q&A Guidance on ICH Guidelines from the FDA for Drug Production
As part of their effort to provide clearer directions for industry, the FDA recently published a new guidance […]
Analytical Chemistry, Pharmaceuticals
PBL Expands Facility to Increase Stability Chamber Capacity
Recently, there has been much excitement and activity here at Pacific BioLabs regarding the future dedicated stability suite. This long […]
Microbiology, Pharmaceuticals
Do You Need Preservative Efficacy Data?
If you have a product that will be on the market, it is advised that you have proof that it […]