Clinical pharmacology plans are not “one size fits all.” Selecting which studies are needed for approval is largely dictated by the nuances of the drug, disease and by the medical need for the drug. This is especially true for oncology. For example, the time from the first-in-human dose to approval is shorter for oncology relative to other indications and the medical need is substantial.
This webinar will cover the paths for successful oncology clinical pharmacology development programs, for both large and small molecule therapeutics. At the end of this webinar attendees should have a better appreciation of 1) the role that clinical pharmacology plays in oncology drug development 2) more insights on when certain studies should be implemented early-on in development and 3) what studies are likely not necessary for approval.