Frontiers | Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA
Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs | SpringerLink
Initial Design Considerations of Trials of Immuno-Oncology: Domains and Elements
Expansion Cohorts Guidance Balances Drug Development With Safety, Rigor
Guidance for Industry, Clinical Considerations for Therapeutic Cancer Vaccines
On Biostatistics and Clinical Trials: June 2021
Phase 0/microdosing approaches: time for mainstream application in drug development? | Nature Reviews Drug Discovery
Statistical controversies in clinical research: building the bridge to phase II—efficacy estimation in dose-expansion cohorts - Annals of Oncology
Groups suggest changes to FDA's guidance expanding eligibility criteria for oncology trials | RAPS
1 Current regulatory guidance on FIH dose selection and preclinical... | Download Table
Early-drug development in the era of immuno-oncology: are we ready to face the challenges? - Annals of Oncology
EX-99.3
Adaptive Design Methods in Clinical Trials - ppt download
Design and Conduct Considerations for First‐in‐Human Trials - Shen - 2019 - Clinical and Translational Science - Wiley Online Library
Immune checkpoint inhibitor-based combinations: is dose escalation mandatory for phase I trials? - Annals of Oncology
How to Choose the Maximum Recommended Safe Dose for First-Time-In-Human Clinical Trials
1 US FDA general guide for FIH dose selection for a cytotoxic agent and... | Download Scientific Diagram
First Dose to Man : general principles (Estimating Safe Dose)
On Biostatistics and Clinical Trials: Phase I Dose Escalation Study Design: "3 + 3 Design"
Exposure driven dose escalation design with overdose control: Concept and first real life experience in an oncology phase I trial - ScienceDirect
Multiple Expansion Cohort Clinical Trials: A Shorter Path to Success for Oncology Drugs
Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs | SpringerLink
Early phase clinical trials to identify optimal dosing and safety - ScienceDirect
Frontiers | Predicting Approximate Clinically Effective Doses in Oncology Using Preclinical Efficacy and Body Surface Area Conversion: A Retrospective Analysis
Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity | RAPS
10 tips for improved drug development
Considerations and Opportunities for Your Investigational Drug Service
