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The proper filing of an investigational new drug (IND) application is required before projects can progress into first-in-human studies. Several parts of the process—like collecting appropriate chemistry, manufacturing, and control data—can be confusing. This PharmTech eBook on Preparing to File Your IND aims to help drug makers avoid common pitfalls in the IND application process, explain what’s needed to secure a successful IND approval, and break down the regulatory requirements for both IND filings and GMPs in early development. Download |