Core D: Drug Development

摘要

ABSTRACT Core D (Myrdal) Drug Development The Drug Development Core will serve the individual Projects and the Program Project as a whole by providing necessary services and a unique combination of expertise in pharmacology/toxicology, pharmaceutics, manufacturing and regulatory affairs that enable the clinical translation of topical agents. This objective will be accomplished by the following Specific Aims: 1) To prepare stable formulations of promising new agents that can be safely and effectively delivered to the epidermis following topical application through a) preformulation activities, b) formulation development and c) determination of percutaneous absorption and dermal toxicity; and 2) Facilitate the translation of agents into the clinic by a) performing preclinical toxicology studies consistent with GLP practices and monitoring the stability of the formulation lots used in these studies, and b) coordinating and preparing New Drug (IND) applications for FDA approval and supervising production and distribution of clinical grade supply for human trials in Project 3. Implementation of these aims will allow Project Leaders the ability to circumvent problems with epidermal delivery which may hinder development of otherwise promising topical agents, and optimize the crucial selection criteria for advancement of new agents to clinical testing. This will greatly enhance the ability to translate basic science discoveries into new skin cancer chemopreventive drugs.