Tag: IND

  • Clinical Dose Optimization

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    Alicia
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    In Oncology In oncology, dose finding trials started using 3+3 dose escalation/expansion to select the recommended phase 2 dose (RP2D) and determine the maximum tolerated dose (MTD) in the 1990s. The earliest treatments for cancer – cytotoxic chemotherapies – had a steep dose-response curve and limited drug target specificity. Due to the lack of available…

  • FDA Expanded Access Programs

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    Alicia
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    History and Background Expanded Access Programs (EAP) are governed by 21 CFR 312, Subpart I and are also referred to as “compassionate use.” They are designed to allow use of investigational drugs outside a clinical trial for subjects who do not meet the requirements of active running trial(s). There are 3 types of EAP: individual…

  • Is a Pre-IND Meeting really needed?

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    Alicia
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    If polled, most executive teams would say they don’t want to take the time to do a Pre-IND meeting before submitting an initial investigational new drug (IND) application. I get it, it takes time, and time is money. But consider it can take MORE time to get your IND through the Food and Drug Administration…