Oncologic Phase 0 Trials Incorporating Clinical Pharmacodynamics: from Concept to Patient

作者: James H. Doroshow , Ralph E. Parchment

DOI: 10.1158/1078-0432.CCR-07-4562

关键词: Clinical trialMechanism (biology)PharmacodynamicsPharmacologyMedicineInvestigational New DrugClinical study designPharmaceutical industryMedical physicsTherapeutic intentPharmacokinetics

摘要: The U.S. Food and Drug Administration recently issued an Exploratory Investigational New (IND) guidance that provides a platform for the evaluation of targeted anticancer agents in small, early-phase human clinical trials can be used to establish feasibility proof-of-principle target modulation assays, as well preliminary pharmacokinetics molecular imaging potential new molecules. exploratory IND allows reduced requirements manufacturing toxicologic assessment. Early done this fashion have no therapeutic intent. In series articles CCR Focus, development mechanism, its effect on trial design pharmacodynamics, ethical implications nontherapeutic investigations, perspective pharmaceutical industry approach are examined.

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