Drugs assessment methods

Hutchinson TA, Lane DA. 1989. Assessing methods for causahty assessment of suspected adverse drug reactions. J Clin Epidemiol 42 5-16. 

Jones, S.A., Moore, L.B., Wisely, G.B. and Kliewer, S.A. (2002) Use of in vitro pregnane X receptor assays to assess CYP3A4 induction potential of drug candidates. Methods in Enzymology, 357, 161-170. 

ASSESSMENT METHODS USED IN DRUG EXPERIMENTS ON HEALTHY VOLUNTEERS... 

Dose effect studies with well-known drugs can be used to determine the sensitivity of different assessment methods in experiments of this kind the lowest dose of a given drug that leads to reliable changes from baseline on a particular parameter can be considered a marker of its sensitivity. An assessment method is recognized as being particularly sensitive when it indicates a drug effect at doses that do not yet induce effects on other parameters measured at the same time. 

Colpaert FC (1987) Drug discrimination methods of manipulation, measurement, and analysis. In Bozarth MA (ed) Methods for Assessing the Reinforcing Properties of Abused Drugs. Springer-Verlag, New York, Berlin, Heidelberg, pp 341-372... 

The nanomaterials thus manufactured in different industries—particularly drugs and pharmaceuticals— might pose risks to human health and other organisms due to their composition, reactivity, and unique size. Nanotechnology research and development, particularly in medical research, work at the micro- and nanoscale levels to develop new drug delivery methods, therapeutics, and pharmaceuticals. In such areas of research it is equally important to consider the potential interactions of nanomaterials with the environment and the associated risks. This involves studying the effects of natural nanoparticles in the air and soil, life cycle aspects of manufactured nanomaterials, and their fate and transport. Risk assessment also includes studies... 

Topical dorzolamide does not appear to cause a change in retinal circulatory variables, including venous diameter and volumetric blood flow rate, after a single dose in normal subjects. The drug also does not have any apparent effect on retrobulbar hemodynamics as determined by color Doppler imaging. In some studies, however, improvements in retinal, choroidal, and retrobulbar blood flow as determined by various assessment methods and hemodynamic markers demonstrate that dorzolamide alone or in combination therapy may improve ocular blood flow in patients with glaucoma and ocular... 

Miremont G, Haramburu F, Begaud B, Pere JC, Dangoumau. Adverse drug reactions Physicians opinions versus a causality assessment method. Eur J Clin Pharmacol 1994 46 285-9. 

Colpaert, F. C. (1987). Drug discrimination Methods of manipulation, measurement, and analysis. In M. A. Bozarth (Ed.), Methods of assessing the reinforcing properties of drugs 341-372). New York Springer-Verlag. 

Rochon J, Protiva P, Seeff LB, et al. Reliability of the Roussel Uclaf Causality Assessment Method for assessing causality in drug-induced liver injury. Hepatology. 2008 48(4) 1175-1183. 

Assessment methods describe how the evaluator will collect data to evaluate performance for each criterion. Examples from the template are review of selected monitoring forms, chart notations, or orders review of adverse drug reaction or incidence reports review of in-... 

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