An example of the timing and duration for some of the nonclinical activities that contribute to the registration of a new chemical entity via an IND and NDA is presented in the timeline on the following pages. This is a very brief outline that concentrates on the Safety Pharmacology, ADME and Toxicology aspects of the nonclinical development process discussed above. Many of the myriad formulation, medicinal chemistry, and pharmacology activities associated with the process of new drug development are not captured in this timeline. Also, the actual studies and timing of the studies required for each stage of drug development will vary on an individual case basis.

Download Tox Study Timing Chart in PDF version or MS Excel version (this Excel spreadsheet uses grouping. Please click the "+" sign to expand a section or "-" sign to collapse).

Download printable version of our booklet Preclinical Toxicology - Points to Consider in Program Design (PDF).