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 Preservative Efficacy testing is essential to cosmetic/personal care and drug manufacturers for identifying optimal preservative combination(s) and concentrations(s) of preservatives

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Best Practices
Sierra de Blank

Modernization of Cosmetics Regulation Act of 2022

The Modernization of Cosmetics Regulation Act of 2022 (commonly known by its acronym “MoCRA”) was signed into law on December 23, 2022.  Its intent is to modernize federal regulatory oversight of cosmetic and personal care products and create a comprehensive and uniform national framework for their regulation. Contained within MoCRA

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Woman testing a product for cosmetic claims substantation
Businesses
Craig Weiss

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. Puffery, or emotive claims, are meant to grab the emotions of consumers but don’t necessarily say much about product benefits.

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Businesses
CPT Labs

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 data do we need to collect?   How will we collect it?   From whom and from how many?  

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A scientist examining a sample for drug product contaminants
Businesses
CPT Labs

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 products, which resulted in high-profile product recalls in 2021.  One might argue that chemical contaminants have always been present in

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Businesses
CPT Labs

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 products, which resulted in high-profile product recalls in 2021.  One might argue that chemical contaminants have always been present in

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A scientist looking at a sample for drug product testing
Businesses
CPT Labs

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 Found in Drug Products Classification of Drug Product Chemical Contaminants and their Sources API Impurities Extractables And Leachables Supply Chain

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Lab technician working in a lab that requires environmental monitoring
Businesses
CPT Labs

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 goal of controlling the quality of that environment. Environmental conditions that are often monitored include but are not limited to

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Female scientist performing in vitro toxicological testing in a lab
Businesses
Steve Nitka, V.P. In-Vitro Technology

Why You Need to Use CPT For In-Vitro Toxicological Testing Services

What is Toxicology? Toxicology is the science of poisons, including the effects of those deleterious substances on living organisms. In vivo toxicology is the branch of the science that investigates those effects using laboratory animals upon which testing is conducted. In contrast, in vitro toxicology is the branch of the

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Pharmacist showing customer an OTC Drug
Businesses
William J. Neumann

10 Common Pitfalls When Launching OTC Drug Products in the US

Regulatory Status of Over-The-Counter (OTC) Drugs OTC Drug products (also referred to as ‘Nonprescription Drugs’) are defined by FDA as “drugs that are safe and effective for use by the general public without seeking treatment by a health professional.” With only a few exceptions, OTC Drugs may be launched in

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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

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