De Young & Hayden Pharma Development Resources

Resources

Critical Steps of Pharmaceutical Development (DYH checklist)
FDA "Animal Rule"
FDA Guidance: 505 (b)
How to Prepare for an Important Meeting with Regulatory Authorities (DYH guide)
ICH CTD Overview
MHLW R egulation
Overview of Statistical Significance (the basics)

Following are links to a few documents and websites that we have found either to be useful or
interesting. As a matter of convenience, we have gathered them here.

Selected Documents

Selected Websites