For the past several years, the FDA has emphasized the importance of modeling and simulation. Recent and ongoing innovations in the field, including advanced statistical and computational methodologies, continue to shape the way regulators and sponsors think about efficient drug development and especially clinical pharmacology. To keep up with this fast-paced and ever-changing world, it is critical to consider your clinical pharmacology plan as early as possible 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 2020 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: