How Do You Choose Partners to Develop the Product?
Developing your idea (20 min)
Whilst Talleen may or may not be stopped using the mice he finds, ethically and practically he can’t progress a marketing application. For example in laboratories, they use specific mice & clones which also make it easier to demonstrate efficacy and scale up trials.
Medical regulation was introduced to prevent harm to humans, animals (and increasingly the environment) from the development of medicinal products and devices. This included the promotion of medicines with advertising claims that could not be scientifically proved
These examples show advertising of drug history in pictures from western perspective and a WHO history of drug regulation.
Regulation covers a set of practices which are different across countries but for FDA and EMA approval are known as Good Laboratory Practice, Good Manufacturing Practice and Good Clinical Practice. Pharmaceutical development can be inspected by regulators and inappropriate practices subject to enforcement procedures to improve standards.
Clinical Trials
Clinical trials to support an application for authorisation have to prove that the product works and that its side effects are acceptable. In order to eliminate the effects of other diseases, patients entered in the trials are carefully chosen so that they don’t have other complicating conditions. Typically clinical trials involve patients numbering in thousands. They are registered with
- ClinicalTrials.gov (USA)
- Clinical Trials Register (Europe)
- Clinical Trials Registry (International - WHO)
For clinical trial approval, you will need to complete a series of documents including a protocol synopsis.
Examples