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

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

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

Guidance Recap Podcast | Translation of Good Laboratory Practice Study Reports: Questions and Answers

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 | 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

Guidance Recap Podcast | 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

Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General Considerations

Guidance Recap Podcast | Population Pharmacokinetics