The Preclinical and Clinical Developmental and Regulatory Evaluations Core (Core B) will be responsible for the provision of test materials for use by all components of the Program, including subcontractors performing animal modeling and toxicology studies, as well as overall Project Management of the regulatory development of the final ring products. Thus, ImQuest BioSciences staff will coordinate the synthesis, storage and shipping of compounds required for evaluation, the interactions with a regulatory consultant responsible for providing advice on the development of the ring product, the performance of safety pharmacology and toxicology testing, including irritation and absorption studies, the synthesis of GMP material for use in the ring product and for submission of the pre-IND and IND documents leading to the pre- Phase 1 human clinical trial.
The Preclinical and Clinical Developmental and Regulatory Evaluations Core will provide all required expertise and capability to lead the product devlopment efforts through the IND-enabling studies and result in the submission of an IND to the FDA for approval to conduct a pre-Phase 1 human clinical trial to test the safety of an intravaginal ring product.
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