Processes clinical

New Drug Approval Process Clinical and Regulatory Management,... 

Medical devices are regulated on the basis of a three-level risk classification. The highest risk products are the class 3 products that require premarket applications, almost always with clinical data that demonstrate that the product is safe and effective for the intended use. By default, a novel product is a class 3 product unless there is an approval application for initial approval as a class 2 device (the de novo process). Clinical trials for class 3 products before they are approved usually require an IDE, which is similar to the IND required for investigational drugs. 

Many drugs will be used in elderly subjects, and certain diseases, for example, Alzheimer s disease, are associated with the ageing process. Clinical studies to test the efficacy and safety of medicinal products in elderly subjects need to take account of the following ... 

Table L Prevention of aflatoxin contamination of cottonseed by toxigenic strains of AspergiUus flavus with a strain of the fungus which does not produce aflatoxins (Cotty, 1989. Proc. 38th Oilseed Processing Clinic, pg. 30)...

Fig. 8.11. The classifier development process. Clinical knowledge provides us with a set of classes for supervised classification (top, right). Large numbers of spectra from large sample numbers are reduced to a set of potentially useful features (top, left) or metrics. A modified Bayesian algorithm operates on the metrics to provide predictions that are compared to a gold standard. The end result of the training and validation process is an optimized algorithm, metric set, calibration and validation statistics, and sensitivity analysis of the data...

Some factors or covariates may cause deviations from the population typical value generated from system models so that each individual patient may have different PK/PD/disease progression profiles. The relevant covariate effects on drug/disease model parameters are identified in the model development process. Clinical trial simulations should make use of input/output models incorporating... 

During the informed consent process, clinical investigators should plan to allow sufficient time for patients to review a consent and ask questions regarding the research. Patients must be permitted to take the form with them while they are considering participation however, the form must be signed in front of a witness. In addition, the IRB may request that a witness sign the informed consent, as well. The principal investigator may not serve as a witness. A copy of the consent document must be provided to the patient. 

Laboratory personnel collecting or processing clinical specimens from confirmed, probable, or suspected patients. 

H. R. Leffler, in Proceedings 33rd Oilseed Processing Clinic, New Orleans, Louisiana, January 16-17, 1984. 

The State Institute for Drug Control is responsible for supervision in the pharmaceutical sector, medical device approval, the registration process, clinical trial approval, withdrawcil of drugs cmd medical devices, control of advertising and inspection of GMP, GLP and GCP. 

Millstein, L. G., Specific Requirements, Content, and Format of an NDA, New Drug Approval Process Clinical and Regulatory Management, R.A. Guarino (ed.)(New York, NY Marcel Dekker, Inc., 1987). 

Olson, S.C., Bockbrader, H., Boyd, R.A., Cook, J., Koup, J.R., Lalonde, R.L., Siedlik, P.H., and Powell, J.R. Impact of population pharmacokinetic-pharmacodynamic analyses on the drug development process. Clinical Pharmacokinetics 2000 38 449-459. 

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