DOMESTIC PRACTICE AND INTERNATIONAL EXPERIENCE IN CONDUCTING QUALITY CLINICAL RESEARCH

Phase I/III full clinical trials of investigational new drugs (INDs) and generic bioequivalence studies are conducted using experimental drugs or clinical examples. Clinical examples are most often produced either on pilot plant or on specialized semiwork-scale plants that do not directly involve development of technology. In some cases, full (serial) production might be used for this purpose. Its advantage is non-commercial clinical examples production during the stage of clinical trials and then commercial release (after a medicine registration). Special attention is paid to quality assurance of Clinical examples as it plays an important role in guarantee of trial subjects protection and scientific validity of results. Clinical examples production, in turn, is connected with certain difficulties in comparison with serial production release. This is the result of inadequate optimization of technological processes and control procedures used in the case of the compendial requirements absence toward active substances and dosage forms. Difficulties also arise with production packaging and marking. Moreover, potential negative influence on the personnel involved in manufacture requires better understanding. Consequently, clinical examplesс production should be performed in strict observance of the high-performance quality system principles. This article contains a review and comparison of quality and production requirements for drugs in clinical trials; the high importance of international harmonization in proceedings of full clinical trials with investigational new/innovative molecules is also highlighted. The information is based on Russian and foreign regulatory documentation.

clinical trials, investigational new drugs, clinical examples, legal and regulatory documentation, international harmonization of clinical trials

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