Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs | SpringerLink
On Biostatistics and Clinical Trials: June 2021
Clinical Development of Gene Therapies: The First Three Decades and Counting: Molecular Therapy - Methods & Clinical Development
How to design a dose-finding study using the continual reassessment method | BMC Medical Research Methodology | Full Text
Early phase clinical trials to identify optimal dosing and safety - ScienceDirect
How to Choose the Maximum Recommended Safe Dose for First-Time-In-Human Clinical Trials
Exposure driven dose escalation design with overdose control: Concept and first real life experience in an oncology phase I trial - ScienceDirect
EX-99.3
FDA draft guidance aims to expedite first-in-human clinical trials for oncology drugs and biologics - Pearl Pathways
10 tips for improved drug development
1 Current regulatory guidance on FIH dose selection and preclinical... | Download Table
FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs
Groups suggest changes to FDA's guidance expanding eligibility criteria for oncology trials | RAPS
Immune checkpoint inhibitor-based combinations: is dose escalation mandatory for phase I trials? - Annals of Oncology
Frontiers | Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA
1 US FDA general guide for FIH dose selection for a cytotoxic agent and... | Download Scientific Diagram
Guidance for Industry, Clinical Considerations for Therapeutic Cancer Vaccines
Statistical controversies in clinical research: building the bridge to phase II—efficacy estimation in dose-expansion cohorts - Annals of Oncology
Multiple Expansion Cohort Clinical Trials: A Shorter Path to Success for Oncology Drugs
5 Tips To Avoid An IND Clinical Hold: Regulatory Guidance And Insights | Premier Consulting
Dose-Finding Schemes in Clinical Trials
