Highly variable drugs evaluation

Tothfalusi L, et al. Evaluation of bioequivalence of highly variable drugs. Pharmaceutical Research, 2001, 18 728-733. 

Current Thinking Within the FDA for the Evaluation of Highly Variable Drugs and Drug Products... 

Shah, P. et al., Evaluation of orally administered highly variable drugs and drug formulations, Pharm. Res., 13 1590-1595, 1996. 

Chemical properties that may affect drug absorption from the airway surface into the systemic circulation include molecular weight, protein binding, and lipophilicity [8], although the extent of absorption is highly variable [10]. However, the extent of absorption into the systemic circulation is felt to be minimal. More research is warranted to evaluate the impact of other patient variables on systemic exposure resulting from inhaled therapies. 

European Medicines Evaluation Agency, Committee for Medicinal Products for Human Use (CHMP). Concept paper for an addendum to the note for guidance on the investigation of bioavailability and bioequivalence Evaluation of bioequivalence of highly variable drags and drug products. Doc. Ref. EMEA/CHMP/EWP/147231/2006, April 2006. 

Numerous activity studies have been performed on bee pollen. However, results of these are extremely difficult to evaluate or duplicate due to the highly variable nature of this food/drug. The following are some of the activities of pollen and its extracts hypolipe-mic in humans and experimental animals puhuang and pollen mixture) antiathero-sclerotic in experimental animals puhuang and pollen mixture) protecting liver from... 

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