This is the third post 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. The previous post in this series briefly discussed Type I
This is the second post 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. Planning a successful human in-use clinical study begins with some
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
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
Regulatory Status of Cosmetic and Personal Care Products in the US Cosmetic and personal care products sold in the US are regulated by the FDA under the Federal Food, Drug and Cosmetic (FD&C) Act of 1938. In spite of the fact that cosmetics have an excellent safety record, key statutory
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This is the third post of a four-part series on simple statistics for clinical trials. Without too much technical detail, this series of posts is
This is the second post of a four-part series on simple statistics for clinical trials. Without too much technical detail, this series of posts is
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
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
Regulatory Status of Cosmetic and Personal Care Products in the US Cosmetic and personal care products sold in the US are regulated by the FDA
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