Analytical Consequences of Potent Drugs
Pharmaceutical companies having their own R & D organization are increasingly confronted with the severe demands of the registration authorities. Besides the proof of safety and efficacy a third criterion is developing: a new drug in a given therapeutic area must be better than existing ones, in respect of therapeutic effect, fewer or no side-effects, or both criteria. This trend has led to the development of a number of rather potent drugs, having low dose regimes. Besides the implications for departments involved in synthesis and pharmacology, there are consequences for other disciplines such as analysis.
KeywordsIrritable Bowel Syndrome Amide Bond Determination Limit Peak Plasma Level Registration Authority
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