IND Preparation
Focus and attention to details are some of the requirements in an Investigational New Drug (IND) preparation. An IND application allows a pharmaceutical company to test an experimental drug in humans during clinical trials.
A standard IND application should contain preclinical data to assess whether the drug can be tested safely in humans, the chemical composition and manufacturing methods to be used to manufacture the drug, the procedures on how the clinical studies will be done based on the qualifications of the clinical investigators, and the steps that will be taken to get the consent of the research subjects.
To further ensure the process will meet the requirements of the FDA, a good step is to schedule a preclinical discussions with the FDA. This is preceded by preparation of a Pre-IND Briefing Book in which a summary of pharmacology and the preclinical plan can be submitted for their review . This can often lead to a better understanding of any additional research experiments and animal testing that could be required by FDA at the time of the IND submission.
PharmaDirections provides the scientific and regulatory experts to guide you through this process and to prepare the documents for submission. One of our key contributions is evaluating the existing data at the time of the Pre-IND preparation and proposing the questions that will be critical for the FDA's review. Our activities could include any of the following:
- Develop the preclinical strategy and plan
- Prepare for the Pre-IND meeting
- Write and submit the Pre-IND Briefing Book and questions
- Participate in the Pre-IND meeting with the FDA
- Prepare the entire IND, submit it and defend any questions the FDA raises
- Conduct any or all of the IND enabling program