FDA Guidance Recap Podcast

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

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

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

Highlights for FDA guidance documents straight from the authors

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

Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers

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—Podcast for Patients

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

Thoughts on newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”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

Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments