Pharmaceutical Industry Essay Example | Topics and Well Written Essays - 500 words

Pharmaceutical Industry - Essay Example This is to ensure the safety of administering a new drug to health volunteers and patients (Novartis 2004). Prior to the therapeutic trials in patients, which is the Phase 1 trials, the pharmaceutical company will need to have: the preclinical testing data and findings from the laboratory studies, the manufacturing information, clinical protocols and investigator information in the form of an Investigator's Brochure which will contain all the information about the study drug (MHRA 2006). This information will be required by the licensing authority, which in the UK is the Medicines and Healthcare products Regulatory Agency as part of the application for a Clinical Trials Authorisation which would enable a trial to be conducted in humans. In addition to this Authorisation, the pharmaceutical company will need to obtain a favourable ethical opinion and approval from the site where this drug will be tested. Once all required approvals are in place, the drug can be tested in a Phase 1 trial in healthy subjects. If the results of this trial are positive and no serious adverse events or suspected unexpected serious adverse events occur, then this progresses to a Phase 2 trial in subjects with the disease or medical condition. The key issues that