Clinical investigator

Einahy, all data, including the results of the clinical investigation, ate collected in a New Dmg Apphcation (NDA) and sent to the EDA. Once approved, the new dmg goes into production. After manufacturing begins, the new dmg products must be monitored in clinical use in the marketplace for reports of untoward reactions. This amounts to post-approval surveillance known as Phase IV. All such reports must be submitted to the EDA in a timely manner. 

Other studies indicate that sucrose does not cause hyperactivity. Carbohydrate ingestion increases levels of serotonin (5-hydroxytryptamine), a brain neurotransmitter that promotes relaxation and sleep. Dietary sucrose should theoretically have a calming effect and reduce activity, manifestations which have been observed in case studies (63). To date, clinical investigations have failed to show a significant connection between sucrose consumption and aggressive or dismptive behavior (66). 

Elestolol sulfate is a nonselective, ultrashort acting P-adrenoceptor blocker. It has no ISA and produces weak inhibition of the fast sodium channel. The dmg is under clinical investigation for supraventricular tachyarrhythmias, unstable angina, and acute MI. In humans, flestolol has hemodynamics and electrophysiologic effects similar to those of other P-adrenoceptor blockers. The pharmacokinetics of flestolol are similar to those of esmolol. It is 50 times more potent than esmolol and the elimination half-life is 7.2 min. Recovery from P-adrenoceptor blockade is 30—45 min after stopping iv infusions. The dmg is hydrolyzed by tissue esterases and no active metabohtes of flestolol have been identified (41). 

Clinical Pharmacology Unit, University of Cambridge, Level 6, Centre for Clinical Investigation, Addenbrooke s Hospital, Cambridge, UK... 

El 1 Clinical Investigation of Medicinal Products in the Pediatric Population... 

Sec. 312.50 General responsibibties of sponsors Protection of Human Subjects Financial Disclosure by Clinical Investigators Institutional Review Boards (IRBs)... 

NAME AND Tm.E OF THE PERSON RESPONSIBUE FOR MONDORING THE CONDUCT AND PROGRESS OF THE CLINICAL INVESTIGATIONS... 

According to US regulations, drugs shipped to test facilities for non-clinical investigations must contain the follo vmg label warning ... 

The provision of clinical data in support of conformity with the requirements of the directives does not necessarily mean that the device has to be subjected to actual clinical investigations. Instead, the manufacturer may present critical evaluations of... 

Studies to investigate the safety and effectiveness of In Vitro Diagnostic (IVD) medical devices under intended use conditions are conducted as performance evaluations. They are considered to present less risk than clinical investigations since, by their nature, studies involving IVDs cannot have any direct impact on the health and safety of trial subjects. 

Before initiating a clinical investigation, the manufacturer (or his/her authorised representative) must prepare a statement containing the information outlined in Figure 10.2, and notify the relevant Competent Authorities of the proposed study. The manufacturer must also keep available for inspection by the Competent Authorities the information outlined in Figure 10.3. Unlike for clinical trials, a standard application form has not been developed. Instead, appropriate application forms are... 

Figure 10.1 Key requirements for the conduct of clinical investigations with medical devices.

Figure 10.2 Information to be included in a clinical investigation statement.

Figure 10.3 Information relating to clinical investigations that must be maintained available to Competent Authorities for inspection.

Devices intended for clinical investigations must bear the following statement on the labelling CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use. ... 

Including indications for use, device description, aiternative practices and procedures currentiy avaiiabie for the condition, marketing history (US or foreign) non-ciinical laboratory studies, clinical investigations and overall conclusions. 

Data from clinical investigations on human subjects, plus statements as regards investigators, IRBs and informed consent. 

Information to justify reliance on a single clinical investigation, where applicable. 

Risk Clinical Data Authorisation of Clinical Investigations Instructions for Use Conformity Assessment Procedure... 

---