New Age Thinking: US FDA’s Temple Sees Third Era Of Drug Development
New Age Thinking: US FDA’s Temple Sees Third Era Of Drug Development
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Robert Temple, the FDA’s voice of institutional memory, believes drug regulation has quietly entered a third era: the “Age of Individualization.” Unlike the prior eras of safety and efficacy, there is no milestone legislation to set the ground rules. But, Temple stressed, there have been significant changes in areas like the assessment of drug-drug interactions, metabolic response to therapeutics, and in the FDA’s willingness for sub-population analyses. Is there a change in the air that will result in further change in drug development as it relates to the Age of the Individual?
Publisher: Pinksheet
- Description
The “Age of Individualization” is upon us, according to the FDA’s unofficial historian Robert Temple, but unlike the prior drug development eras of safety and efficacy, there has been no milestone legislation to set the ground rules. Metabolic differences between individuals had been an unknown concept, but they’re now routinely examined at the FDA, as are potential drug interactions, Pharmacokinetics, and population PK so more is known at the time of drug approval. Learn the milestone events leading to the Age of Individualization, and what Mr. Temple has to say about the future of AI and machine learning in the context of drug development, drug formulation, and prescribing.
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