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
What is a Raw Material? A raw material is a basic material that is used to make a product. The formulation of each product, whether it be a drug, cosmetic/personal care product or dietary supplement is a unique combination of raw materials. Active ingredients, inactive ingredients, preservatives and processing aids
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
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
Regulatory Status of Cosmetics and Important Legal Concepts The Federal Food Drug and Cosmetic (FD&C) Act defines “cosmetic” products by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the
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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
What is a Raw Material? A raw material is a basic material that is used to make a product. The formulation of each product, whether
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
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
Regulatory Status of Cosmetics and Important Legal Concepts The Federal Food Drug and Cosmetic (FD&C) Act defines “cosmetic” products by their intended use, as “articles