Potency, drugs factors affecting

So far we have focused our attention on the time course of drug effect. While the study of these effects can be helpful in understanding the mechanism of drug action and factors affecting efficacy and potency, it usually does not provide information on how drug exposure influences therapeutic response. 

Drugs, among all the environmental factors that we are exposed to, may be particularly likely to interact specifically and selectively with the genetic properties of a given individual, as their potency pitches them into a narrow therapeutic window , precariously balanced between potent potions and perilous poisons. We would predict that, based on a patients innate, individual biological makeup -as it affects the interaction with a drug - one or the other of these properties may manifest itself this phenomenon is covered by the term pharmacogenetics. 

The FDA s dehnition of comparability protocol is a well-defined, written plan for assessing the effect of specific CMC changes in the identity, strength, purity, and potency of a specific drug product as these factors relate to the safety and effectiveness of the product. A comparability protocol describes changes that are covered under the protocol and specifies the tests and studies that will be performed, including analytical procedures that will be used, and acceptance criteria that will be achieved to demonstrate that specified CMC changes do not adversely affect the product. ... 

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