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White Paper

Best Practices for Developing High Quality, On Time Submissions

Sponsors often struggle with submission planning. Read this white paper to learn how to develop…

CertaraJanuary 8, 2018

Publication

Model-informed Drug Development for Malaria Therapeutics

CertaraJanuary 6, 2018

On-Demand Webinar

How to Perform Level C IVIVC in Phoenix

Step-by-step guidance for Level C IVIVC studies.

CertaraDecember 13, 2017

Publication

Prediction of Olanzapine Exposure in Individual Patients Using Physiologically-based Pharmacokinetic Modeling and Simulation

CertaraNovember 30, 2017

Publication

Exposure-response of Veliparib to Inform Phase 2 Trial Design in Refractory or Relapsed Patients with Hematological Malignancies

CertaraNovember 1, 2017

Publication

A Distributed Delay Approach for Modeling Delayed Outcomes in Pharmacokinetics and Pharmacodynamics Studies

CertaraOctober 30, 2017

Publication

Influence of Molecular Size on the Clearance of Antibody Fragments

CertaraOctober 1, 2017

Publication

Clinical Pharmacology Tools and Evaluations to Facilitate Comprehensive Dose Finding in Oncology: A Continuous Risk-Benefit Approach

CertaraSeptember 15, 2017

On-Demand Webinar

Agreeing to Submission Document Timelines & Sticking to Them: Fairy Tale or Reality?

In this webinar, Steve Sibley defined best practices for establishing submission timelines that won’t change,…

CertaraSeptember 14, 2017

Publication

Medical Writing Competency Model—Section 2: Knowledge, Skills, Abilities, and Behaviors

CertaraAugust 30, 2017

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