Drug Development Teams

In addition to the scientific disciplines, e.g., pharmacology, chemistry, toxicology, drug metabolism and pharmacokinetics, and biopharmaceutics, involved on the discovery team, the preclinical drug development team has a number of new players. These new players include, among others ... 

A critical function of the drug development team is the development of the study protocol. The study protocol must clearly describe the study design and... 

While a drug development team may have only one primary physician, it may have multiple scientists. Pharmacokineticists, pharmacologists, toxicologists, and pharmaceutical scientists are all involved in the clinical development of drugs. The contributions of scientists to a drug development project are derived from their experience in both scientific methodology and basic research. ... 

One aspect of clinical research that requires extensive contribution by the drug development team personnel is study monitoring. Study monitors oversee the planning. 

The drug development team must ensure that reference standards will be available to support the launch of a newly approved product once FDA approval is obtained. The quality control function is typically separate from the analytical development function in most firms, so a high level of cooperation and communication are critical. As launch approaches, the drug development team must work closely with the commercial manufacturing quality control unit to coordinate the supply of reference standards to the firm s compound distribution system. It is useful to involve marketing forecasts to predict the approximate amounts of reference standards—based on projected batches—that will be necessary to support a worldwide launch. 

The pharmacist s role on the drug development team has greatly expanded the professional opportunities of individuals with backgrounds in pharmacy. Pharmacists can provide valuable therapeutic insight into medical research. Training of pharmacists as clinical scientists with... 

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