Analytical Chemistry
How to Ensure the Safety of E-Cigarettes
What are e-cigarettes?
E-cigarettes or “e-cigs” are battery operated machines which unlike conventional cigarettes, convert nicotine into vapor instead of smoke, […]
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Analytical Chemistry, Medical Device
Chemical Characterization of Medical Devices: An Overview
At PBL we hear a lot of questions from medical device clients regarding FDA material and chemical characterization requirements. To […]
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 […]
Biologics
The Importance of Immunogenicity Testing in Biotherapeutic Development
Immunogenicity, defined as the ability of a substance to produce an immune response, is key to a successful and safe […]
Analytical Chemistry, Medical Device
A Note on Chemical Characterization
According to the ISO standard 10993, a medical device should be biocompatible i.e. not induce any adverse effects when it […]
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 […]
Medical Device
Toxicologists Weigh in on Biocompatibility
Medical Device biocompatibility, once considered just a "box-checking" activity, continues to become more complex. This was the focus of a […]
Biologics
Botulinum toxin A versus B. What is the Difference?
Have you ever wondered what the difference is between the different types of botulinum toxin?
There are seven distinct variations of […]
Medical Device
Why Device Makers Can Benefit from Increased Use of CROs
Increasingly, device makers are discovering what pharmaceutical companies have known for many years – that using CROs to support regulatory […]
Microbiology
Antibacterial Textile Testing – Prove That Your Product Kills Bugs
Demand in the market for quality textiles that meet consumers’ demands for comfort and freshness has been increasing. Antibacterial performance […]