Evaluation Studies
| Definition: |
Studies determining the effectiveness or value of processes, personnel, and equipment, or the material on conducting such studies. For drugs and devices, CLINICAL TRIALS; DRUG EVALUATION; and DRUG EVALUATION, PRECLINICAL are available. |
| Notes: |
do not use for evaluation of drugs ( = probably DRUG EVALUATION or DRUG EVALUATION, PRECLINICAL or CLINICAL TRIALS terms); do not use for evaluation of patient care ( = probably terms indented under QUALITY OF HEALTH CARE) |
| Also Called: |
Critique,Evaluation,Evaluation Indexes,Evaluation Report,Evaluation Research,Methodology, Evaluation,Pre-Post Tests,Qualitative Evaluation,Quantitative Evaluation,Theoretical Effectiveness,Use-Effectiveness |
Evaluation Studies Categories.
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Device Approval - Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA. |
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Drug Approval - Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug. |
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Drug Evaluation - Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals. |
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Drug Evaluation, Preclinical - Preclinical testing of drugs in experimental animals or in vitro for their biological and toxic effects and potential clinical applications. |
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Product Surveillance, Postmarketing - Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale. |
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Program Evaluation - Studies designed to assess the efficacy of programs. They may include the evaluation of cost-effectiveness, the extent to which objectives are met, or impact. |
Evaluation Studies Definitions and Terms
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