Ethics, Human Rights, and Safety
Declaration Of Helsinki
Code of Federal Regulations 21 part 50 Protection of Human Subjects
ICH E2A: Expedited Reporting
Investigational New Drug Application
Microdose Studies and Exploratory IND’s
FDA guidance: Exploratory IND Jan 2006
EMEA guidance: 2004
FDA Guidance: Unique Human Metabolites Feb 2008
Lappin, et al, CREAM Sudy
Sarapa et al, Absolute Bioavailability
Vuong, Ruckle, et al, ZDV Study
Robinson, Review of Microdose Study Experience
CCR Editorial Reviewing Microdose Experience
First Time In Humans and Phase I Study Design
Buoen, 2005, Review of Phase I Single Ascending Dose Study Designs
Duff Report, and First Time In Humans with Biologics
ICH E6: Good Clinical Practices
ICH E8: Considerations for Clinical Trials
Roffey et al, Review of ADME Studies
FDA Draft Guidance: Drug Interaction Studies
ICH E15: Genomics