EX-99.3
Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs | SpringerLink
Design and Conduct Considerations for First‐in‐Human Trials - Shen - 2019 - Clinical and Translational Science - Wiley Online Library
Expansion Cohorts Guidance Balances Drug Development With Safety, Rigor
Moving Beyond 3+3: The Future of Clinical Trial Design | American Society of Clinical Oncology Educational Book
Guidance for Industry, Clinical Considerations for Therapeutic Cancer Vaccines
Immune checkpoint inhibitor-based combinations: is dose escalation mandatory for phase I trials? - Annals of Oncology
Exposure driven dose escalation design with overdose control: Concept and first real life experience in an oncology phase I trial - ScienceDirect
Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity | RAPS
FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs
10 tips for improved drug development
A Phase 1, Randomised, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Cannabidiol in Fed Healthy Volunteers | SpringerLink
Frontiers | Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA
On Biostatistics and Clinical Trials: Phase I Dose Escalation Study Design: "3 + 3 Design"
FDA 2013 Clinical Investigator Training Course: Safety Considerations…
Dose-Finding Schemes in Clinical Trials
1 Current regulatory guidance on FIH dose selection and preclinical... | Download Table
Initial Design Considerations of Trials of Immuno-Oncology: Domains and Elements
On Biostatistics and Clinical Trials: June 2021
Early phase clinical trials to identify optimal dosing and safety - ScienceDirect
5 Tips To Avoid An IND Clinical Hold: Regulatory Guidance And Insights | Premier Consulting
1 US FDA general guide for FIH dose selection for a cytotoxic agent and... | Download Scientific Diagram
