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The translation of bench discoveries to the clinic can be a very long and expensive process. If the process is viewed backward from a successful IND or IDE, the major expense is primarily related to the last preclinical phases of the process. However, the overall time expended on the effort occurs from discovery through preclinical testing. The objective of this appendix is to provide reference materials to investigators who will be developing products for clinical applications. A number of different regulations are involved in demonstrating safety and efficacy of products before they can be introduced into humans. In addition to regulations, guidance documents are available to assist in the development process. Standards are also available for certain types of products. The appropriate regulations should be consulted to ensure characterization is sufficient for clinical testing. Following are some of the regulations and Guidance Documents that should be used when developing study plans.
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