News
Academy
Publications
All PublicationsE-Books
Media
Editorial PodcastsEditorial VideosPeer ExchangePractice AcademySponsored PodcastsSponsored Videos
More
Conferences
Conference CoverageConference Listing
Columns
All ColumnsA Closing ThoughtClinical Trial InsightsView from BrusselsView from Washington
Resources
AdvertiseBlogsEventsFront & CenterPartner PerspectivesWhite Papers
Webcasts

Subscribe

  • News
  • Academy
  • Publications
  • Media
  • Conferences
  • Columns
  • Resources
  • Webcasts
  • Subscribe
  • Clinical Operations & Strategy
    • Decentralized Clinical Trials
    • Trial Design
    • Investigative Sites
    • CRO/Sponsor
    • Risk-Based Monitoring
    • Protocol Design
    • Clinical Trial Supply Chain
    • Study Start-Up
    • Early Phase Development
  • DEI
    • Industry Initiatives
    • Diversity Action Plans
    • Recruitment
  • Data Management
    • Analytics
    • Electronic Data Capture
    • Real World Evidence
    • Metrics & Benchmarks
  • Patient Participation
    • Integrated Research
    • CRAACO
    • Enrollment
  • Regulatory
    • Institutional Review Board & Ethics Committee
    • FDA
    • EMA
  • Technology
    • Artificial Intelligence/Machine Learning
    • eClinical
    • mHealth
Spotlight -
CNS Drug Development Resources|
Conference Coverage|
Peer Exchange|
DE&I|
Editorial Videos
Advertisement

Justin Hay, PhD

Advertisement

Senior Director, Certara

Articles by Justin Hay, PhD

FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers

ByJulie Bullock, PharmD,Krithika Shetty, PhD,Amandine Manon, PharmD,Justin Hay, PhD
April 24th 2023

January 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.

Advertisement

Latest Updated Articles

  • FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers
    FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers

    Published: April 24th 2023 | Updated:



Advertisement
Advertisement

Trending on Applied Clinical Trials Online

1

Preparation Tips to Minimize Impact of Regulatory Inspections for IRT Systems

2

Integrating AI Across Legacy Clinical Trial Systems

3

Reimagining Clinical Operations Through Artificial Intelligence

4

Balancing Human Oversight and Automation in AI-Driven Trials

5

2025 SCRS Global Site Solutions Summit: How Standardized CDAs Can Accelerate Site Activation

  • About
  • Advertise
  • Contact Us
  • Editorial Contacts
  • Do Not Sell My Personal Information
  • Privacy Policy
  • Terms and Conditions
Contact Info

259 Prospect Plains Rd, Bldg H
Cranbury, NJ 08512

609-716-7777

  • Applied Clinical Trials
  • BioPharm International
  • Cannabis Science and Technology
  • Chromatography Online
  • Nutritional Outlook
  • Pharmaceutical Commerce
  • Pharmaceutical Executive
  • Pharm Tech
  • Spectroscopy Online
  • Turbo Machinery Magazine
IS1
Brand Logo

© 2025 MJH Life Sciences®

All rights reserved.

Home
About Us
News
Contact Us