Pharmacokinetic Parameters for Sparse and Intensive Sampling – Nonclinical and Clinical Studies
Source category: Submission Standards
Author collections: Shallabh Mehta
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 23
Browse practical work on assembling, validating and documenting clinical data for regulatory review. Conference examples reflect their publication date; consult current agency guidance when deciding how an approach applies to a new submission.
622 papers · Showing 441–460
PP08 The Last Time? Efficiently Scheduling the Pieces of Your Submission Deliverables
Source category: Poster Presentations
Author collections: Charity Quick
PP18 The Importance of Work Instructions When Creating Reviewer's Guides
Source category: Poster Presentations
Practical Guidance for ADaM Dataset Specifications and Define.xml
Source category: Submission Standards
Author collections: Jack Shostak
Process optimization for efficient and smooth e-data submissions to both FDA and PMDA
Source category: Submission Standards
Author collections: Akari Kamitani · Yoshitake Kitanishi
Progression-Free Survival (PFS) Analysis in Solid Tumor Clinical Studies
Source category: Submission Standards
SA01 Development of the Standard BIMO Process to Create the Clinsite Dataset
Source category: Submissions and Agencies
SA01 The EMA, Health Canada and the FDA: Three Agencies Tackle Data Sharing: Synergies and Differences
Source category: Submissions & Agencies
Author collections: Jean-Marc Ferran
SA02 Lessons Learned from an FDA Real- time Oncology Review Pilot Programme: A Novartis & Roche Perspective
Source category: Submissions and Agencies
SA02 Machine-readable Data Not Required for the EMA...Really?
Source category: Submissions & Agencies
Author collections: David Izard
SA03 ADaM Submission – How to Work with the Inconsistencies Between the FDA and PMDA Requirements
Source category: Submissions and Agencies
Author collections: Marianne Carames
SA03 High-quality Study Data Standards for Submission
Source category: Submissions & Agencies
Author collections: Majdoub Haloui · Ellen Asam
SA04 Processing Big Data from Multiple Sources
Source category: Submissions and Agencies
Author collections: Berber Snoeijer · Vijay Pasapula
SA04 Submission of Software Programs to Regulatory Agencies
Source category: Submissions & Agencies
Author collections: Maria Dalton
SA05 Approach of Programming Production Harmonized with Submission
Source category: Submissions & Agencies
Author collections: Chengxin Li
SA05 How Metadata Can Help Drive the Creation of Tables, Figures and Listings
Source category: Submissions and Agencies
Author collections: Judith Goud · Stephen Castellano
SA06 Developing SEND for CBER – Collaborative Workstream Initiative
Source category: Submissions & Agencies
Author collections: Lisa Lin · Susan DeHaven
SA06 Integrated Data and Document Anonymisation for Efficient Data Sharing
Source category: Submissions and Agencies
Author collections: Ali Dootson · Cathal Gallagher
SA07 Navigating FDA Requirements: ISS/ISE Build Strategies
Source category: Submissions and Agencies
Author collections: Priyank Patel
SA07 The Benefits, Challenges and Myths of SEND
Source category: Submissions & Agencies
Author collections: Lou Ann Kramer