As children, we were taught that we should brush and floss the right way in order to prevent cavities. As we’ve gotten older, we’ve learned even more about the many ways that oral care is crucial to staying healthy. The inflammation and infections caused by poor oral hygiene have been
This is the fourth 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. This series has discussed the various types of data that
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
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As children, we were taught that we should brush and floss the right way in order to prevent cavities. As we’ve gotten older, we’ve learned
This is the fourth 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 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
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FDA
Registration# 1000151293
CPT℠ is registered with FDA (FEI # 1000151293) as a Drug Establishment (GMP/GLP/GCP) and a Cosmetic Facility.
DEA
Registration# RC0199744 (Analytical Lab)
Schedule I-V license
Remember, Schedules I-II require DEA Form 222
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US EPA/NJ DEP
Registration# NJD982726648