It is an exciting and innovative time for drug development. For the past several years, FDA Commissioner Scott Gottlieb has continued to emphasize the importance of modeling and simulation. 2017 and 2018 saw a number of historic milestones with regard to new innovations and advanced statistical and computational methodologies. To keep up with this fast-paced, and ever-changing world of drug development, it is critical to consider your clinical pharmacology plan early on in your program.
In this Clinical Pharmacology Planning Toolkit, you will find three essential items that will assist you in planning for a successful clinical pharmacology program in 2019 and beyond.
- Overview of the costs involved in your clinical pharmacology program
- Clinical pharmacology planning timeline & template
- FDA’s Question-Based Review document
Complete the form below to request your Clinical Pharmacology Planning Toolkit: