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A c c e l e r a t o r  M a s s  S p e c t r o m e t r y
Research Services for Drug Development

 

Welcome

Brochures

Key Literature

Regulatory

EMEA position paper on clinical trials with a single microdose

FDA 21CFR Part 361.1 : Radioactive drugs for certain research uses

Poster Presentation: The Radioactive Drug Research Committee - Microdosing

Draft Guidance for Industry, Investigators, and Reviewers - Exploratory IND Studies- DRAFT GUIDANCE from the U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)

Guidance for Industry, Investigators, and Reviewers - January 2006 - U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)

Guidance for Industry - Safety Testing of Drug Metabolites - February 2008 - U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)