Logo Image
News
Academy
Publications
All PublicationseBooks
Media
Editorial PodcastsEditorial VideosPeer ExchangePractice AcademyShortsSponsored PodcastsSponsored Videos
More
Conferences
Conference CoverageConference Listing
Columns
All ColumnsA Closing ThoughtClinical Trial InsightsView from BrusselsView from Washington
Resources
AdvertiseBlogsEventsFront & CenterPartner PerspectivesWhite Papers
Events
Webcasts
Event Calendar

Subscribe

  • News
  • Academy
  • Publications
  • Media
  • Conferences
  • Columns
  • Resources
  • Events
  • Subscribe
  • Event Calendar
  • 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 -
Conference Coverage|
Peer Exchange|
DE&I|
Editorial Videos|
Clinical Operations & Strategy|
Patient Participation
Advertisement

Amandine Manon, PharmD

Advertisement

Director, Clinical Pharmacology and Translational Medicine, Certara

Articles by Amandine Manon, PharmD

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

    April 24th 2023



Advertisement
Advertisement

Trending on Applied Clinical Trials Online

1

Real-Time Clinical Trials Depend on a Scalable EHR-to-EDC Connection

2

What It Actually Means to Embed AI Across the Clinical Operating Model

3

FDA Launches Rare Disease Framework Initiative to Reimagine Drug Development for Small Patient Populations

4

2026 SCRS Global Site Solutions Summit: What Does Al-Assisted Patient Matching Look Like?

5

Building Trust Into Oncology Real-World Evidence: Q&A with Saamir Pasha and Carole Berini, Ontada

  • 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

  • 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

© 2026 MJH Life Sciences®

All rights reserved.

Home
About Us
News
Contact Us