PDA Technical Glossary
PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.
The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the PDA Technical Report Portal.
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Highly Hazardous Drug Active
A drug active that can cause serious adverse effects at typical doses. Those adverse effects are generally not related to the main therapeutic activity of the drug, and includes effects such as carcinogenicity, mutagenicity, genotoxicity, reproductive hazards, allergenicity, and cytotoxicity. (TR29)