Advent Calendar-20

So we are looking at our drug development pathway and we can take bog standard drug powder dissolve it in water and administer to animals but that isn't good enough for human work.

So in animals we have to do things to conform with Good Laboratory Practice (GLP) but to deliver drugs to humans the standards are even higher and things have to be done to GMP standards.

Good manufacturing practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

Good manufacturing practices, along with good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries.

All guidelines follow a few basic principles:

 So we have to get chemists involved again to formulate your drug into the pill or capsule or as an solution for injection. If you have a water soluble (dissolves in water) drug, like ours then this is easy to formulate but some are like brick dust and difficult to dissolve in anything.

Once you have drugs in pill form and the ethics in place we are ready to go. Phase I here we come!