The basis of the categorisation of drug compounds is inherent to their toxicity. Drug entities are initially classified in terms of their respective toxicity and potency characteristics. Toxicity can be determined in various ways, such as through observations in pre-clinical toxicological investigations and in clinical trials. Other factors are: Mechanism of pharmacological action, the Therapeutic dose, Spectrum and severity of clinically observed side effects of a specific drug substance and the observed occupational exposure limits within the pharmaceutical industry. Ultimately, the assessment process involves placing a drug into a specific toxicity and potency category and a respective control band, there are various approaches and numbers or categories, but the most widely accepted categorisation of drug compounds involves placing a drug into one of four categories as following:
- Low Toxicity
- Intermediate Toxicity
- Highly Potent
For more information on Categories 1 & 2: Low and Intermediate Toxicity Drugs and Categories 3 & 4: Potent and Highly Potent Drugs, click on their specific link.