In the Pharmaceutical Industry, what does Preclinical, Clinical and Formulations mean?

Question

As far as the whole drug development process.

Answer 1

Formulations is the department of a company that researches and decides what the correct recipe for a new drug should be. How much active ingredient and excipients are needed, how long they are blended, etc.

Preclinical trials are tests that show the new drug does what it is supposed to do and are safe. These tests usually occur on animals.

Clinical trials are the first human studies of the new drug. There are 3 phases of clinical trials. The first phase proves safety for humans, and helps indicate efficacy and toxicity. Phase I is conducted on a very small group of heathy volunteers (a few dozen). Phase II moves to a larger group (100-200) and helps prove efficacy of the new drug even more. Phase II also is conducted with a placebo, for comparison. Phase III moves on to even more subjects (1000-2000). The FDA reviews Phase III data when deciding whether or not to approve the new drug for the general public.