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Episode | Date |
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Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
7:34
Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
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May 25, 2023 |
Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
11:22
Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
|
May 24, 2023 |
Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs
Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs
|
May 22, 2023 |
Guidance Recap Podcast | Podcast for Patients — Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs
14:14
Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs—Podcast for Patients
|
May 19, 2023 |
Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications
12:45
Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications
|
May 15, 2023 |
Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
12:17
Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
|
Feb 10, 2023 |
Guidance Recap Podcast | Multiple Endpoints in Clinical Trials
11:49
Guidance Recap Podcast | Multiple Endpoints in Clinical Trials
|
Oct 20, 2022 |
Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children
14:52
Thoughts on newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”
|
Sep 23, 2022 |
Guidance Recap Podcast | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
8:41
Guidance Recap Podcast: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
|
Jul 26, 2022 |
Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
11:29
Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
|
Jun 29, 2022 |
Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
8:51
Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
|
Jun 24, 2022 |
Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General Considerations
8:02
Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations
|
Apr 14, 2022 |
Guidance Recap Podcast | Population Pharmacokinetics
6:24
Guidance Recap Podcast: Population Pharmacokinetics
|
Feb 04, 2022 |
Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
12:20
Recap Podcast: Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
|
Dec 27, 2021 |
Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products
13:06
Guidance Recap Podcast: Benefit-Risk Assessment for New Drug and Biologic Products
|
Sep 29, 2021 |
Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics
6:59
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
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May 21, 2021 |
Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast
11:33
The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors.
|
Dec 15, 2020 |
Guidance Recap Podcast | Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance
6:54
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript
|
Feb 28, 2020 |
Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance
14:05
Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript
|
Feb 28, 2020 |