In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. Regulatory Pathway 505(b)(2) versus 505(b)(1) In the
Without concrete guidelines, it can be confusing when determining what nonclinical studies are needed for a Pre-Investigational New Drug application (PIND) meeting. However, in our experience, the answer is this: it is critical that the nonclinical program provides sufficient data to allow the FDA to
As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics. High-quality IND-enabling studies demonstrate that a drug is reasonably safe for use in humans and that it exhibits sufficient pharmacological activity
