Drug Development Teams clinical

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 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... 

In view of the clinical importance of the corrected Q-T interval (QTc) prolongation in drug development, the DIDB team has created a new set of data summarizing QTc effects of drugs. In addition, 150 publications already in the database were recently reviewed to highlight the articles with QTc measurement and cases of QTc prolongation. Case reports of torsades de pointes/ventricular fibrillation were also individualized for easy access by DIDB users. 

One of the final responsibilities of the preclinical drug development project team is to prepare an IND and to submit the appropriate documents to the FDA or other regulatory agency. As the development of the drug candidate moves into the clinic, the preclinical project team becomes a clinical project team. 

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