Safety studies manufacturing guidelines

Manufacturers retain considerable data on file that are not found in the public literature. These data can include such information as extended stability studies, compatibility studies, drug safety reports, and comprehensive information in the NDA. The guidelines regarding dissemination of this data are subject to company policies and are typically used when no published literature is available. If the data are used and referenced in any communications... 

Anon, Guidelines for the Safety Pharmacology Study Required for Application for Approval of Manufacturing (Import) of New Drugs Notification No. 4., Japan Ministry of Health and Welfare, January 29,1991. 

Ministry of Health and Welfare Guidelines for Safety Pharmacology Studies Required for the Application for Approval to Manufacture (Import) Drugs, Notification YAKUSHIN-YAKU No. 4, Jan. 1991. 

The special needs and vulnerabilities of infants require a clear and complete set of guidelines to assess the safety of infant formulas. Guidelines must also provide an appropriate level of flexibility to address the multitude and diversity of possible new ingredients. It is not realistic or desirable to provide specific recommendations for each potential new ingredient. Thus the committee recommends that the manufacturer or notifier and an expert review panel establish the relative importance of potential adverse effects for each new ingredient and determine the types of preclinical and clinical studies and in-market surveillance needed to accurately assess safety. 

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