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 how statistical planning can influence study effectiveness and value. Types of data Let’s begin with the most basic underpinning for
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, and binding agents. Some carbomers are manufactured using benzene as a polymerization solvent, whilst others employ a benzene-free manufacturing process.
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 of the Federal Food, Drug, and Cosmetic Act in 1938. On the one-year anniversary of the enactment of MoCRA, the
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
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.
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?
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
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
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
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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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
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
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
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
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
Planning a successful clinical study begins with some central questions: What question(s) do we want to answer? What statistical methods will help us
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
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
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
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