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- Per-Episode Audience
Est. listeners per new episode within ~30 days
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5,001 - 25,000 - Active Followers
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501 - 5,000
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On the show
Recent episodes
Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products
Mar 25, 2026
Unknown duration
Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
Oct 22, 2025
Unknown duration
Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
Oct 16, 2024
Unknown duration
Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
Sep 18, 2024
Unknown duration
Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
Jul 15, 2024
Unknown duration
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| Date | Episode | Description | Length | ||||||
|---|---|---|---|---|---|---|---|---|---|
| 3/25/26 | Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products | Guidance Recap Podcast | Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products | — | ||||||
| 10/22/25 | Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments | Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments | — | ||||||
| 10/16/24 | Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development | Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development | — | ||||||
| 9/18/24 | Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies | Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies | — | ||||||
| 7/15/24 | Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics | Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics | — | ||||||
| 4/22/24 | 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 | — | ||||||
| 4/16/24 | 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 | — | ||||||
| 3/26/24 | Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates | Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates | — | ||||||
| 12/21/23 | Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development | Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development | — | ||||||
| 12/11/23 | Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins | Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins | — | ||||||
Want analysis for the episodes below?Free for Pro Submit a request, we'll have your selected episodes analyzed within an hour. Free, at no cost to you, for Pro users. | |||||||||
| 11/21/23 | Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers | Highlights for FDA guidance documents straight from the authors | — | ||||||
| 10/19/23 | Guidance Recap Podcast | Benefit-Risk Assessment for New Drug and Biologic Products | Guidance Recap Podcast: Benefit-Risk Assessment for New Drug and Biologic Products | — | ||||||
| 5/25/23 | Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products | Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products | — | ||||||
| 5/24/23 | Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers | Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers | — | ||||||
| 5/15/23 | Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications | Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications | — | ||||||
| 10/20/22 | Guidance Recap Podcast | Multiple Endpoints in Clinical Trials | Guidance Recap Podcast | Multiple Endpoints in Clinical Trials | — | ||||||
| 9/23/22 | Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children | Thoughts on newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.” | — | ||||||
| 7/26/22 | Guidance Recap Podcast | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products | Guidance Recap Podcast: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products | — | ||||||
| 6/24/22 | Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations | Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations | — | ||||||
| 4/14/22 | Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General Considerations | Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations | — | ||||||
| 2/4/22 | Guidance Recap Podcast | Population Pharmacokinetics | Guidance Recap Podcast: Population Pharmacokinetics | — | ||||||
| 12/27/21 | Guidance Recap Podcast | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers | Recap Podcast: Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers | — | ||||||
| 5/21/21 | Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics | 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 | — | ||||||
| 12/15/20 | Guidance Recap Podcast | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products Podcast | The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors. | — | ||||||
| 2/28/20 | Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance | Guidance Recap Podcast | In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Final Guidance - Podcast Transcript | — | ||||||
Showing 25 of 26
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Chart Positions
4 placements across 4 markets.
Chart Positions
4 placements across 4 markets.