Industry Blog
Simple Statistics for Clinical Trials Part I: Understanding Data Types
This is the first of a four-part series on simple statistics for clinical trials. Without too much technical detail, this series of posts is intended to offer some background in
Drug Products Containing Carbomers Manufactured With Benzene
What are Carbomers and why do some contain benzene? Carbomers are a group of polymers that are widely used as inactive ingredients in drug products as fillers, emulsifiers, gelling agents,
GAO Assessment of FDA Efforts to Implement MoCRA
The Modernization of Cosmetic Regulation Act of 2022 (MoCRA) was enacted on December 29, 2022 and is the most significant expansion of FDA’s authority to regulate cosmetics since the enactment
Preservative Efficacy Testing: USP 51 Versus PCPC
As its name suggests, Preservative Efficacy Testing (PET) is a procedure for determining the effectiveness of a product’s preservative system after controlled quantities of test microorganisms have been introduced. Antimicrobial
Cosmetic Claims Substantiation
Why Are Cosmetic Claims Substantiation Studies Important? When approaching a claims-support study for any product that produces a cosmetic endpoint, it is important to understand the types of claims available.
Simple Clinical Trial Statistics Overview
Planning a successful clinical study begins with some central questions: What question(s) do we want to answer? What statistical methods will help us answer these questions? What
Drug Product Contaminants: Part Three
There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of benzene in aerosol OTC Sunscreen
Drug Product Contaminants: Part Two
There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of benzene in aerosol OTC Sunscreen
Drug Product Contaminants: Part One
Each of the following topics will be discussed over the course of this three-part article exploring Drug Product Contaminants: Definition of a Drug Product Contaminant Types of Contaminants that are
Environmental Monitoring Programs to Reduce Contamination
The term Environmental Monitoring generally refers to the processes and activities that are conducted for the purpose of characterizing and monitoring the quality of a defined environment, with the eventual
