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...European medicines agency june cpmp ich topic s a safety pharmacology studies for human pharmaceuticals step note guidance on transmission to march interested parties deadline comments november approval by date coming into operation westferry circus canary wharf london e hb uk tel fax mail emea eu int http www reproduction and or distribution of this document is authorised non commercial purposes only provided the acknowledged introduction objectives guideline was developed help protect clinical trial participants patients receiving marketed products from potential adverse effects while avoiding unnecessary use animals other resources provides definition general principles recommendations background have been performed worldwide many years as part evaluation there however no internationally accepted definitions design conduct term first appeared in topics timing trials m preclinical biotechnology derived that should be conducted support therapeutics humans details including their were ...