ABSTRACT
If pharmacology is important for the prescriber, it is even more important during the production, testing and licensing of a new drug. Almost the full range of pharmacological knowledge comes into play during this complex process, which can take up to 12 years and cost over £1 billion. The pharmaceutical manufacturer is responsible for all of this preliminary scientific work, at the end of which the company submits a dossier, often running to hundreds of pages in length, to the national drug licensing organisation, e.g. the Medicines and Healthcare Products Regulatory Agency in the UK and the Food and Drugs Administration in the USA.3 A typical application comprises the following sections:
description of the active chemical compound
description of the quality control processes during its manufacture
description of the pharmaceutics - the vehicle (e.g. a powder) in which the active substance is carried, the process of tabletting or preparation of capsules or injectate, etc. Excipients may include additives necessary to stabilise the active chemical compound and, in the case of some injections, antiseptic agents to inhibit the growth of micro- organisms
description of the mandatory preclinical tests conducted in animal models, including toxicity and carcinogenesis testing
description of the clinical trials carried out in human volunteers and patients, of which there are three phases prior to the licensing and marketing of a new drug.
