Drug Safety Research Unit

Inman WH, Pearce G, Wilton L, Mann RD. Angiotensin Converting Enzyme Inhibitors and Asthma. Southampton Drug Safety Research Unit, 1994. 

In 1986, the UK Drug Safety Research Unit at Southampton published a report on its prescription event monitoring study of etodolac (SEDA-13, 80). Etodolac was rated effective in only 56% of 9109 patients, and the Unit concluded that the average dosage used... 

Clark DW, Layton D, Wilton LV, Pearce GL, Shakir SA. Profiles of hepatic and dysrhythmic cardiovascular events following use of fluoroquinolone antibacterials experience from large cohorts from the Drug Safety Research Unit Prescription-Event Monitoring database. Drug Saf 2001 24(15) 1143-54. 

This form of adverse event monitoring was pioneered and developed by the Drug Safety Research Unit (DSRU) in Southampton. The aim is to... 

Drug Safety Research Unit (United Kingdom) Intensive Medicines Monitoring Program (New Zealand)... 

There are now a variety of options in several countries, from basic two-day courses run by the Drug Safety Research Unit in the UK (http //www.dsru.org) through to certificate, diploma and masters level. Training courses are also run by the two international societies mentioned below. 

Another reason that international planning may be difficult in drug research concerns the way in which various countries view early clinical trials and drug safety. Some countries view volunteer subjects and patients differently from a regulatory perspective, making it easier to recruit and enroll subjects for Phase 1 studies than it is to recruit and enroll patients for Phase 2 or Phase 3 studies. In the United States, both patients and volunteers are viewed in the same way, and studies with patients and volunteers cannot be initiated until the FDA has authorized an IND. 

Poor adherence to the schedule of taking the study medication will obviously confound interpretation of the efficacy and safety of the drug. There is usually good compliance in clinical pharmacology studies, especially those conducted in units where drugs are administered by the staff. However, in clinical research trials adherence to medication may be poorer. 

DoD is not just another purchaser in a commercial market, however. It becomes a developer of drugs when demand is mainly or exclusively for military use. Under these circumstances, DoD requirements for CBW defense drugs involve the department in the full spectrum of research, development, testing for safety and effectiveness through clinical trials or alternate means, production, acquisition, and issues of medical use. (This may also be the case for naturally occurring diseases that rarely appear in the United States and for which the domestic civilian market is limited.)... 

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