1.1 General consideration
Monitoring of different Clinical Research enables research ethics boards to ensure that, the standards that they approve in theory are being applied in practice [1] [2]. It has been suggested that such review has to be performed regularly and that it include monitoring of a variety of aspects of research, such as the consent process, adherence to the approved protocol and data integrity [1] [3].
1. Weijer C, Shapiro S, Fuks A, Glass KC, Skrutkowska M. Monitoring clinical research: an obligation unfulfilled. CMAJ 1995; 152:1973-1980.
2. Berry J. Local research ethics committees can audit ethical standards in research. J Med Ethics 1997; 23:379-381.
3. Heath EJ. The IRB's monitoring function: four concepts of monitoring. IRB Rev Hum Subj Res …show more content…
Brahmankar D M, Jaiswal S B, (Feb-5 2009). Biopharmaceutics and Pharmacokinetics. 2nd edition, page no.315-363 Ref...9.
B. Clinical Response: Clinical trials in humans establish safety and effectiveness of drug products and may be used to determine bioavailability. However, clinical trials approach is the least accurate, least sensitive, and least reproducible of the general approaches for determining in-vivo bioavailability. The FDA considers this approach only when analytical methods and pharmacodynamic methods are not available to permit use of one of the approaches as described above.
Comparative clinical studies have been used to establish bioequivalence for topical antifungal drug products (e.g., ketoconazole) and for topical acne preparations. For dosage forms intended to deliver the active moiety to the bloodstream for systemic distribution, this approach may be considered acceptable only when analytical methods cannot be developed to permit use of one of the other approaches. [11]
Shargel L, Wu-Pang S, Yu A B C. (August 2004) Applied Biopharmaceutics and Pharmaceutics. 5th edition, Chapter 15.
Monitoring of different Clinical Research enables research ethics boards to ensure that, the standards that they approve in theory are being applied in practice [1] [2]. It has been suggested that such review has to be performed regularly and that it include monitoring of a variety of aspects of research, such as the consent process, adherence to the approved protocol and data integrity [1] [3].
1. Weijer C, Shapiro S, Fuks A, Glass KC, Skrutkowska M. Monitoring clinical research: an obligation unfulfilled. CMAJ 1995; 152:1973-1980.
2. Berry J. Local research ethics committees can audit ethical standards in research. J Med Ethics 1997; 23:379-381.
3. Heath EJ. The IRB's monitoring function: four concepts of monitoring. IRB Rev Hum Subj Res …show more content…
Brahmankar D M, Jaiswal S B, (Feb-5 2009). Biopharmaceutics and Pharmacokinetics. 2nd edition, page no.315-363 Ref...9.
B. Clinical Response: Clinical trials in humans establish safety and effectiveness of drug products and may be used to determine bioavailability. However, clinical trials approach is the least accurate, least sensitive, and least reproducible of the general approaches for determining in-vivo bioavailability. The FDA considers this approach only when analytical methods and pharmacodynamic methods are not available to permit use of one of the approaches as described above.
Comparative clinical studies have been used to establish bioequivalence for topical antifungal drug products (e.g., ketoconazole) and for topical acne preparations. For dosage forms intended to deliver the active moiety to the bloodstream for systemic distribution, this approach may be considered acceptable only when analytical methods cannot be developed to permit use of one of the other approaches. [11]
Shargel L, Wu-Pang S, Yu A B C. (August 2004) Applied Biopharmaceutics and Pharmaceutics. 5th edition, Chapter 15.