publication . Article . 2007

Regulatory perspectives of Type II prodrug development and time-dependent toxicity management: Nonclinical Pharm/Tox analysis and the role of comparative toxicology

Kuei-Meng Wu; James G. Farrelly;
Open Access
  • Published: 22 Apr 2007
Many therapeutic agents are prepared in prodrug forms, which are classified into Type I, II and subtypes A, B based on their sites of conversion. Recently, an increasing number of INDs have appeared as Type II prodrugs that often contain dual tracks of toxicity profile exploration, one on the prodrug and another on the active drug. A comparative toxicology analysis is introduced here to assist reviewers to evaluate the dual toxicity profiles effectively. The analysis helps determine which toxicity is contributed by the prodrug itself, its intermediates, or the active drug itself. As prodrug INDs, or any other new molecular entity (NME) INDs progress into advance...
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free text keywords: Toxicology, Pharmacology, Medicine, business.industry, business, Target organ, Toxicity, Prodrug, Toxicity profile, Drug, media_common.quotation_subject, media_common, Toxicology, New chemical entity, Exposure level
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