Drug substance characterization guidelines

Statements on which regulatory guidelines, such as 21 CFR 58 for FDA GLP compliance, will be followed and on Animal Care Committee protocol review Information on the drug substance, which commonly includes the test article name or number, identification criteria, physical description, who is responsible for test article characterization, the concentration(s) to be used, recommended storage conditions, inventory maintenance, formulation procedures, reserve samples, retention samples, analyses for content and homogeneity (if necessary), disposition, and safety precautions Information on the animal species to be studied, animal husbandry procedures, such as housing, food, water, contaminants, environment conditions, acclimation, and justification of selection... 

Regulatory agencies are continuously pushing the quahty systems that appear in the early phases of drug development. The ICH (International Conference on Harmonization) offers several guidelines for the characterization of the drug substance. Notably, these include ... 

In January 2004, the U.S. FDA issued a guideline for botanical products (2). The information discussed in section VII.A.1 of the guideline pertains to the initiation of characterization of the drug substance. Also, it should be provided for all products. It is important for the safe conduct of clinical trials to ensure the proper identity of botanical raw materials used in the trials. As there is no history of experience in United States with botanical raw materials marketed only outside the United States, a certificate of authenticity of the plant and plant parts should be provided for such materials. A trained professional who is competent to determine authenticity should sign this certificate. This information should also be provided, if available, for a botanical raw material marketed in the United States. 

The U.S. FDA provides a detailed description of the characterization of the substances obtained by recombinant DNA technique. The details are provided in the website mentioned in Ref. 3. In addition, several guidelines of the ICH and other guidelines at the U.S. FDA provide additional information on stability testing of biological products. What follows in the successive paragraphs is an outline of what constitutes the required minimum studies. A drug substance is... 

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