“Pacific Pharma Group offers efficient product development through thoughtful design.”
Resources I. Ethics, Human Rights, and Safety Declaration Of Helsinki Code of Federal Regulations 21 part 50 Protection of Human Subjects ICH E2A: Expedited Reporting II. Investigational New Drug Application CFR 312 Investigational New Drug Application III. 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 IV. 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ICH E6: Good Clinical Practices ICH E8: Considerations for Clinical Trials Roffey et al, Review of ADME Studies FDA Draft Guidance: Drug Interaction Studies ICH E15: Genomics V. Japanese Bridging Studies: ICH E5: Guidelines
I. Ethics, Human Rights, and Safety Declaration Of Helsinki Code of Federal Regulations 21 part 50 Protection of Human Subjects ICH E2A: Expedited Reporting
II. Investigational New Drug Application CFR 312 Investigational New Drug Application
III. 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
IV. 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ICH E6: Good Clinical Practices ICH E8: Considerations for Clinical Trials Roffey et al, Review of ADME Studies FDA Draft Guidance: Drug Interaction Studies ICH E15: Genomics
V. Japanese Bridging Studies: ICH E5: Guidelines
