Basic principles of non-clinical development

Adequate active drug substance must be produced for all non-clinical studies:

• Small quantities (milligrams to grams) are usually needed for non-clinical studies. Later on in clinical studies and for the market, the production will then be scaled up to produce larger quantities.
• For Good Laboratory Practice (GLP) studies, the drug substance must be qualified or follow Good Manufacturing Practice (GMP) for each batch produced.

 Some key CMC steps during the non-clinical phase are:

• To determine the dose and administration (how the medicine is given, e.g. the dose or how often it is given).
• To describe the physico-chemical characteristics (traits) of the medicinal product in detail.
• To test the stability & purity of the medicinal product.
• To develop and validate the methods used to quantify the active substance in body fluids such as blood, plasma, or urine. This is done in activity and side effect studies.
• To develop a prototype of the medicine which will be used in the clinic.