Question

Compare and contrast pre-clinical evaluation (pharmacology and toxicology) of biopharmaceuticals and ' small molecule' (<900Da ) drugs.

Answer 1

For preclinical evaluation of biopharmaceuticals usually, non-human primates are used but for preclinical evaluation of small molecules rodent species could also be used. The evaluation is done according to the guidelines of an International Regulatory Agency. The testings on the following categories are needed to be performed for both small molecules and biopharmaceuticals-

Safety pharmacology- tests the effects of the drug on the physiological systems.

Acute toxicity- tests the adverse effects of a substance that result either from a single exposure or from multiple exposures in a short period of time (24 to 96 hours)

Subacute or subchronic toxicity- it includes testing effects of the drug from 1 to 21-28 days with registration of mortality, body weight, haematological, biochemical and urinalysis assay

Chronic toxicity- it includes testing effects of the drug from 1 to 1-3 mon. or 90 days or 6 mon. with registration of mortality, body weight haematological, biochemical and urinalysis assay

Genotoxicity

Carcinogenicity

Developmental and reproductive toxicity

Studies in juvenile animals

According to the area of application of the drug all the tests may not be required.