FDA 2013 Clinical Investigator Training Course: Safety Considerations…
Considerations and Opportunities for Your Investigational Drug Service
Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity | RAPS
First Dose to Man : general principles (Estimating Safe Dose)
Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4–5 December 2014) - Musuamba - 2017 - CPT: Pharmacometrics & Systems Pharmacology - Wiley Online Library
A new pragmatic design for dose escalation in phase 1 clinical trials using an adaptive continual reassessment method | BMC Cancer | Full Text
Frontiers | Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA
5 Tips To Avoid An IND Clinical Hold: Regulatory Guidance And Insights | Premier Consulting
How to Choose the Maximum Recommended Safe Dose for First-Time-In-Human Clinical Trials
Estimating the Maximum Safe Starting Dose for First-in-Human Clinical…
Dose-Finding Schemes in Clinical Trials
Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs | SpringerLink
Groups suggest changes to FDA's guidance expanding eligibility criteria for oncology trials | RAPS
A Phase 1, Randomised, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Cannabidiol in Fed Healthy Volunteers | SpringerLink
Phase 0/microdosing approaches: time for mainstream application in drug development? | Nature Reviews Drug Discovery
1 US FDA general guide for FIH dose selection for a cytotoxic agent and... | Download Scientific Diagram
Exposure driven dose escalation design with overdose control: Concept and first real life experience in an oncology phase I trial - ScienceDirect
Immune checkpoint inhibitor-based combinations: is dose escalation mandatory for phase I trials? - Annals of Oncology
Initial Design Considerations of Trials of Immuno-Oncology: Domains and Elements
1 Current regulatory guidance on FIH dose selection and preclinical... | Download Table
FDA draft guidance aims to expedite first-in-human clinical trials for oncology drugs and biologics - Pearl Pathways
FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs
Expansion Cohorts Guidance Balances Drug Development With Safety, Rigor
Design and Conduct Considerations for First‐in‐Human Trials - Shen - 2019 - Clinical and Translational Science - Wiley Online Library
Guidance for Industry, Clinical Considerations for Therapeutic Cancer Vaccines
10 tips for improved drug development
Early-drug development in the era of immuno-oncology: are we ready to face the challenges? - Annals of Oncology
