Episodes
Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
Published 10/16/24
Published 09/18/24
Published 07/24/24
Published 07/15/24
Guidance Recap Podcast | E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-approval Clinical Trials
Published 04/22/24
Published 04/22/24
Guidance Recap Podcast | Pharmacokinetics Study Design Considerations in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing
Published 04/16/24
Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates
Published 03/26/24
Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development
Published 12/21/23
Guidance Recap Podcast | Drug-Drug Interaction Assessment for Therapeutic Proteins
Published 12/11/23
Highlights for FDA guidance documents straight from the authors
Published 11/21/23
Guidance Recap Podcast: Benefit-Risk Assessment for New Drug and Biologic Products
Published 10/19/23
Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
Published 05/25/23
Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
Published 05/24/23
Published 05/22/23
Guidance Recap Podcast | Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs—Podcast for Patients
Published 05/19/23
Guidance Recap Podcast | Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications
Published 05/15/23
Published 10/20/22
Thoughts on newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”
Published 09/23/22
Guidance Recap Podcast: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
Published 07/26/22
Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
Published 06/29/22
Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
Published 06/24/22
Guidance Recap Podcast: Bioavailability Studies Submitted in NDAs or INDs – General Considerations
Published 04/14/22
Guidance Recap Podcast: Population Pharmacokinetics
Published 02/04/22
Recap Podcast: Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
Published 12/27/21
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