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| Titre | Date | Durée | |
|---|---|---|---|
| Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations | 07 Jul 2026 | 00:08:51 | |
Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations | |||
| Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development | 22 Jun 2026 | 00:14:54 | |
Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development | |||
| Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products | 25 Mar 2026 | 00:13:01 | |
Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products | |||
| Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments | 22 Oct 2025 | 00:08:57 | |
Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments | |||
| Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development | 16 Oct 2024 | 00:12:09 | |
Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development | |||
| Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies | 18 Sep 2024 | 00:18:04 | |
Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies | |||
| Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations | 24 Jul 2024 | 00:24:04 | |
Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations | |||
| Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics | 15 Jul 2024 | 00:14:56 | |
Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics | |||
| Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials | 22 Apr 2024 | 00:12:15 | |
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 | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing | 16 Apr 2024 | 00:12:04 | |
Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing | |||
| Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates | 26 Mar 2024 | 00:12:02 | |
Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates | |||
| Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins | 11 Dec 2023 | 00:13:29 | |
Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins | |||
| Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers | 21 Nov 2023 | 00:13:39 | |
Highlights for FDA guidance documents straight from the authors | |||
| Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products | 19 Oct 2023 | 00:12:55 | |
Guidance Recap Podcast: Benefit-Risk Assessment for New Drug and Biologic Products | |||
| Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products | 25 May 2023 | 00:07:34 | |
Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products | |||
| Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers | 24 May 2023 | 00:11:22 | |
Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers | |||
| Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications | 15 May 2023 | 00:12:45 | |
Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications | |||
| Guidance Recap Podcast | Multiple Endpoints in Clinical Trials | 20 Oct 2022 | 00:11:49 | |
Guidance Recap Podcast | Multiple Endpoints in Clinical Trials | |||
| Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children | 23 Sep 2022 | 00:14:52 | |
Thoughts on newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.” | |||
| Guidance Recap Podcast | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products | 26 Jul 2022 | 00:08:41 | |
Guidance Recap Podcast: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products | |||
| Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General Considerations | 14 Apr 2022 | 00:08:02 | |
Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations | |||
| Guidance Recap Podcast | Population Pharmacokinetics | 04 Feb 2022 | 00:06:24 | |
Guidance Recap Podcast: Population Pharmacokinetics | |||
| Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers | 27 Dec 2021 | 00:12:20 | |
Recap Podcast: Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers | |||
| Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics | 21 May 2021 | 00:06:59 | |
Dr. Dan Rubin, statistician, Division of Biometrics IV in CDER’s Office of Biostatistics sharing some thoughts draft guidance Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics | |||
| Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast | 15 Dec 2020 | 00:11:33 | |
The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors. | |||
| Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance | 28 Feb 2020 | 00:14:05 | |
Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript | |||
| Guidance Recap Podcast | Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance | 28 Feb 2020 | 00:06:54 | |
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript | |||
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