Clinical data

Limited clinical data on BMY 21502 (11) suggest that some benefit may be provided to patients with dementia (87,88). This expectation is based on the abihty of (11) to increase the level of arousal and attention in patients with certain types of dementia. BMY 21502 enhances long-term potentiation... 

Japan. In Japan, registration of dmgs for aquatic species requires the same data as those required for dmgs on other animals. The Ministry of Agriculture, Eorests, and Eisheries and the Ministry of Welfare control the use of chemicals in aquaculture in Japan (17). The preclinical data requirements include product chemistry, toxicity (acute, subacute, special) using rats and mice, safety to target animals, and metaboHsm. The requirements for clinical data include avadabiHty and residues. As of July 1990, more chemicals were registered for aquacultural use in Japan than in any other country (Table 4). 

Other Cardiovascular Agents Effecting Atherosclerosis. A large amount of clinical data is available concerning semm Upid profiles in patients subjected to dmg therapy for other cardiovascular diseases. Atheroma, for example, may be the underlying cause of hypertension and myocardial infarction. There are on the order of 1.5 million heart attacks pet year in the United States (155). 

Due to their promising activities in preclinical investigations, the first clinical data for these new generations of anticancer drugs are eagerly awaited. 

Ultimately, the non-clinical data will form a substantial part of the regulatory submission that is required for marketing authorisation. 

The study will commence with the administration of low doses, as judged from the non-clinical data. As the study progresses - and provided that there are no indications that it is unsafe to do so - the dosage levels may be increased past the anticipated therapeutic range. Subjects are closely monitored for changes in vital signs (blood pressure, heart rate, body temperature, etc.) and the emergence of any adverse side effects (nausea, drowsiness, pain, headache, irritability, hair loss, etc.). 

Each proposed trial should be supported by existing non-clinical or clinical data... 

E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data Good Clinical Practice E6(R1) Good Clinical Practice... 

As a first step, the sponsor is required to prepare an investigator s brochure (IB). This must be an objective compilation of available clinical and non-clinical data on the... 

The CTD is organised into five modules. A schematic representation of the stmcture and hierarchy is shown in Figure 6.1. Module 1 is designed to contain region-specific information such as application forms and other administrative provisions that may apply. As such, it is not harmonised and is not considered part of the CTD. The other four modules present the technical data in a harmonised format. Module 2 should contain critical overview assessments of the quality, non-dinical and clinical data, together with summaries of the non-clinical and clinical data. The objective of this section is to provide reviewers with an introduction to the submission, and to orient... 

There are a number of other scenarios where medicinal products may be brought to market exempt from the requirement to submit applications supported by full pre-dinical and clinical data. 

The EU will accept applications without supporting pre-clinical and clinical data, if it can be demonstrated that the active substances have been in well-established medical use in the Community for at least 10 years, with recognised efficacy and an acceptable level of safety. This route would be appropriate for many common over-the-counter (OTC) products. Safety and efficacy is supported by providing copies of published scientific literature as part of the submission that is, the submission relies on safety and efficacy data available in the public domain, as opposed to confidential data from authorised applications that is the cornerstone of generic applications. 

Standard authorisation Yes (SPC) Yes (CMC and Stability) Yes (Pre-clinical and Clinical data) Yes (Clinical data)... 

As a general rule, clinical data are required as evidence to support conformity with the requirements of the Active Implantable Medical Devices (AIMD) and the Medical Device (MD) directives with regards to safety and effectiveness under the normal conditions of use, evaluation of undesirable side effects, and the acceptability of the benefit/risk ratio. Risk analysis should be used to establish key objectives that need to be addressed by clinical data, or alternatively to justify why clinical data are not required (mainly for Class I devices). The risk analysis process should help the manufacturer to identify known (or reasonably foreseeable) hazards associated with the use of the device, and decide how best to investigate and estimate the risks associated with each hazard. The clinical data should then be used to establish the safety and effectiveness of the device under the intended use conditions, and to demonstrate that any of the residual risks are acceptable, when weighed against the benefits derived from use of the device. 

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... 

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

CFR 601.28 Distribution data Current labelling CMC new information New non-clinical studies New clinical data Status report on post-approval study commitments, e.g. paediatric studies Minor supplementary changes... 

CFR 514.80 (b) 4 New non-clinical and clinical data Adverse events not previously reported Summary of increased adverse event frequency Minor supplementary changes... 

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