Guideline for the Study of Drugs Likely to be used in the Elderly 1989

Even though written 12 years ago with the primary intent to advice sponsors on how to undertake clinical investigation of drugs likely to be used in the elderly, this guideline is a milestone in terms of identifying, explaining, and recommending clinical pharmacology studies in terms of drug-drug interactions, drug-disease interactions, special populations (elderly, renally impaired and hepatically impaired), and pharmacodynamic studies (in the elderly). Further, this guideline also established the concept of "Pharmacokinetic Screen" which has subsequently matured into the science of "Population Pharmacokinetics." In view of the authors, this is a must-read classical document. Not surprisingly, this is also one of the first topics that were finalized at the ICH and in view of the authors, the E7 document, namely "Clinical Trials in Special Populations—Geriatrics" is an excellent update of this '89 document. The E7 document is covered in detail later on in the chapter.

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