Clinical pharmacology is responsible for phase I and II a-defining initial safety, tolerability, kinetics, metabolism and biological effect in patients, as well as developing novel methodologies for the short term evaluation of efficacy of a drug. Some companies also incorporate clinical pharmacokinetics into clinical pharmacology. It is rare for clinical pharmacology to be responsible for all phase II and III full therapeutic evaluation of new chemical entities (N.C.E.s).
But this should not be an excuse for clinical pharmacologists to relinquish the responsibility. Professor Breckenridge points to the critics of clinical pharmacology who say it cannot be separated from clinical medicine. The same criticism could be levelled at industrial clinical pharmacology. How can one department of a large pharmaceutical company have the necessary expertise to cover all exploratory therapeutic programmes?
Another role for clinical pharmacology is its special working relationship with the pre-clinical scientific departments, akin to the amalgamation of pharmacology and clinical pharmacology in academic departments. It could be strengthened by having clinical pharmacology report into the research side of the company, but on balance it is best retained within the clinical function, as many of its responsibilities are concerned with bioequivalence, line extensions, combination products and drug interactions. Clinical pharmacology in industry has a foot in both camps of research and development. It acts as a bridge from animals to man, decide if a new chemical entity has a biological effect and therapeutic potential, but also remain deeply involved in the later stages of drug development necessary for the full development of a compound for global registration.