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IND SUBMISSIONS FOR PHASE I & PHASE II STUDIES MAY REQUIRE TWO IDENTITY TESTS

Executive Summary

IND SUBMISSIONS FOR PHASE I & PHASE II STUDIES MAY REQUIRE TWO IDENTITY TESTS, in addition to an assay, in order to fully characterize the new drug substance in the dosage form, according to a newly released FDA draft guideline. "Since the assay alone might not serve as a satisfactory identity test," the guideline explains, "two identity tests using different methods may be necessary during this phase." The document is entitled, "Draft Guideline for Submitting Supporting Documentation for the Manufacture of Finished Dosage Forms." In stating that "an assay method including adequate acceptance specifications for content of the new drug substance (including antibiotic) in the dosage form should be submitted" with the Phase I and II INDs, FDA explained that "the limits need not be overly narrow but should be tightened as experience with the drug accumulates." FDA added that in addition, "other chemical and physical tests characterizing the dosage form that should be included for tablets, capsules, and suspensions are content uniformity and dissolution profile in acidic, basic, and neutral solutions. Sterility, particulate content, and apyrogenicity should be included for injectables." The drug product guideline joins a series of four other draft guidelines which have been released by FDA to provide assistance to applicants in conforming their submissions to the chemistry and manufacturing controls requirements of the proposed IND and new NDA regulations. The agency released guidelines on drug packaging, drug stability and methods validation during 1984. A draft guideline on drug substances was released simultaneously with the drug product guideline. In an April 25 Federal Register notice announcing the availability of the new guidelines, FDA noted that it is specifically soliciting comments on the nature and extent of supporting documentation for the manufacture of the drug products and drug substances needed to support Phase I investigations. FDA explained that "the proposed investigational new drug regulations incorporated the policy objective of limiting FDA regulations of Phase I investigations primarily to safety concerns to ensure that research subjects are not exposed to unreasonable risk. In the proposal, the agency stated that it intended to limit the scope of chemistry related submissions to that which is necessary to support the scope and duration of the proposed human testing." It was soliciting the comments, FDA said, "in keeping with these goals." Requests for copies of the draft guidelines should be addressed to the Dockets Management Branch, FDA, Rm. 4-62, 5600 Fishers Lane, Rockville, MD 20857.
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