25本のエピソード

The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors. Through conversations with FDA staff, this podcast is intended help communicate salient key points and background information about a subset of cross-cutting guidance documents on topics that seek to modernize and accelerate drug development.

FDA Guidance Recap Podcast U.S. Food and Drug Administration

    • 行政

The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors. Through conversations with FDA staff, this podcast is intended help communicate salient key points and background information about a subset of cross-cutting guidance documents on topics that seek to modernize and accelerate drug development.

    Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials

    Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials

    Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials

    • 12分
    Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing

    Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing

    Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing

    • 12分
    Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates

    Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates

    Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates

    • 12分
    Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development

    Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development

    Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development

    • 15分
    Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins

    Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins

    Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins

    • 13分
    Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers

    Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers

    Highlights for FDA guidance documents straight from the authors

    • 13分

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