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Rho offers their expertise on why it is important to have a pre-IND meeting to ensure a successful IND.
With recent research from Rho, a CRO, it has been presented that a pre-IND meeting is important in order to ensure a successful IND (Investigational New Drug) and a productive pre-meeting can increase that likeliness according to the FDA.
It was mentioned that a pre-IND meeting should serve its purpose to agree on a development program, initial clinical study and nonclinical program in order to bring together a meeting package which will serve as the foundation of your IND. Some topics that should be covered before filing your IND include the topic of scientific or regulatory issues such as clinical trial design, toxicity concerns, unique metabolites, novel formulation, dosing limitations, species selection, and immunogenicity.
With Rho’s input, it has been shared that the pre-IND meeting must be timed wisely, prepared, and needs to provide an early read as well as build a relationship with the FDA in order for a successful IND to take place.
To learn more about Rho, please visit www.rhoworld.com.
Source: Rho (2018, March 27). Rho Offers Reasons Why You Need a pre-IND Meeting [press release]