PRODUCT DEVELOPMENT

Exactly how pharmaceutical companies develop new products can be something of a mystery. So we'd like to throw some light on the R&D process that we use.

    formulation           preclinical           clinicaltrials           registration
     1. Formulation                 2. Pre-clinical               3. Clinical Trials           4. Registration

Stage 3 is the clinical phase. Here the product goes through a number of phases that really test the product with different objectives in mind.

Phase 1 is testing pharmacokinetics. Phase 2 tests the dosage. Phase 3 is about establishing the efficacy of the product.

Finally, if you tick all the boxes in your clinical testing, you can then apply to get the product registered. A company applies to a regulator in a particular country or region using what is known as the Common Technical Document.

In effect, the CTD system provides a quality check on drug development done elsewhere before the product can be sold locally. It means, for example, that when we license Maxigesic to other countries around the world, we don’t have to go through the whole process again from scratch.