Overview of Regulatory Expectations for Introducing Novel Therapies into Clinical Trials
Early introduction of novel therapies into clinical trials for diagnosis, treatment or prevention of disease has relied on the accumulation of adequate scientific data. For the most part, the data to support “first in humans” studies have been derived from preclinical studies designed to ask specific questions of the new product and/or product class. This product-specific approach to (pre)clinical program planning and evaluation has been commonly referred to as the “case-by-case” approach. A combination of early dialogue, to identify the critical questions unique to an emerging technology, and a science-based rational approach, to answer these questions, has resulted not only in facilitation of clinical development, but in providing the appropriate data to support marketing applications.
KeywordsPreclinical Safety Early Dialogue Manufacturer Assistance Regulatory Expectation Preclinical Toxicology Study
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