結果 : fda phase 2 clinical trial guidance
3:54

The Four Phases of Clinical Trials | Diversity in Clinical Trials | AKF

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FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy

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FDA Webinar on the Infant Formula Transition Plan for Exercise of Enforcement Discretion (Part 1)

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Overview of the FDA Product-Specific Guidance Program

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Designing First-In-Human Trials for Small Molecules and Biologics

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FDA Approval Considerations with Dr. Paul Kluetz

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FDA Webinar on New Infant Formula Transition Plan (Part 2)

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Industry Panel Insights on FDA's Guidance and Inclusive Clinical Trials

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Navigating clinical trials in pulmonary hypertension

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FDA’s guidance on clinical trials with psychedelic drugs

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Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6of14) REdI 2018

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FDA Clinical Investigator Training Course (CITC) 2023, Day 1 – Part 2

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FDA Clinical Trial Guidance During COVID-19

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Vol 6 - A Brief Guide to Understanding: FDA's CMC Guidance for Phase 2 and 3 INDs

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Clinical Hold in ALL Study, FDA Draft Guidelines, Expanded Approval in Hodgkin Lymphoma

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FDA's current thinking on cGMP compliance for Phase I Investigational Drug and Biologic products

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Most Common Issues with CDISC-SEND Data in FDA Toxicology Review – Sep. 12, 2019

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Worried about Your Next FDA Meeting? Key Tips to Make It a Success

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Impact of FDA guidelines for risk based monitoring on clinical trials

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51:57

Webinar — Comparing CTA Submission (EMA/Health Canada) to IND Applications (FDA) for Phase I Trials

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