Guidance for Industry Clinical Considerations for Therapeutic Cancer Vaccines [excerpts]
Statistical Considerations for Clinical Trials During COVID-19: Background
Moving Beyond 3+3: The Future of Clinical Trial Design | American Society of Clinical Oncology Educational Book
A Phase 1 Dose-Escalation Study of the Cardiac Myosin Inhibitor Aficamten in Healthy Participants | JACC: Basic to Translational Science
PDF) Dose Escalation Methods in Phase I Cancer Clinical Trials
JCM | Free Full-Text | Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington's Disease Patients—A Randomized Phase 2 Clinical Trial
Early phase clinical trials to identify optimal dosing and safety - ScienceDirect
The changing landscape of phase I trials in oncology | Nature Reviews Clinical Oncology
Guidance for Industry
Phases of Drug Development Process, Drug Discovery Process | NorthEast BioLab
5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights > Premier Research
1 Current regulatory guidance on FIH dose selection and preclinical... | Download Table
Twitter \ Tatiana Prowell, MD على تويتر: "Tweet 1/2❗️ FDA Guidance on Conduct of #ClinicalTrials of Med Products during #COVID19 Pandemic for Industry, Investigators, & IRBs. Participant safety #1. Discusses protocol chng/violations,
Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs | SpringerLink
Dual Agent Dose Escalation Designs
Phases of clinical research - Wikipedia
A new pragmatic design for dose escalation in phase 1 clinical trials using an adaptive continual reassessment method | BMC Cancer | Full Text
Estimating the Starting Dose in Phase I - Dose Response
1 US FDA general guide for FIH dose selection for a cytotoxic agent and... | Download Scientific Diagram
Frontiers | Predicting Approximate Clinically Effective Doses in Oncology Using Preclinical Efficacy and Body Surface Area Conversion: A Retrospective Analysis
Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs | SpringerLink
Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics
Expansion Cohorts Guidance Balances Drug Development With Safety, Rigor
Phase 0/microdosing approaches: time for mainstream application in drug development? | Nature Reviews Drug Discovery
Moving Beyond 3+3: The Future of Clinical Trial Design | American Society of Clinical Oncology Educational Book
Dose Finding in the Clinical Development of 60 US Food and Drug Administration–Approved Drugs Compared With Learning vs. Confirming Recommendations - Lyauk - 2019 - Clinical and Translational Science - Wiley Online Library
