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Helping Sponsor Meet EMA Policy 0070 Requirements

Clinical Transparency & Disclosure, Regulatory, Case Study

Streamlining the Preparation of 1-Year and 2-Year PSURs

Regulatory, Case Study

Delivering High-Quality, Timely Responses to EMA Safety Queries

Certara Services, Regulatory, Case Study

CMC Writing Support Helps Client Lift Clinical Hold

Regulatory, Case Study

Enhancing Pharmacokinetics Workflows at Charles River

Case Study Resources - Featured, Certara Products, Certara Products - Phoenix, Certara Services, Modeling and Simulation, Modeling and Simulation - PK/PD, NCA, Pharmacokinetics, Pharmacometrics, PK/PD, pre-update, Case Study

Clinical Candidate Selection

Modeling and Simulation - QSP, Case Study

Phase 1 Interim Analysis

Modeling and Simulation - QSP, Case Study

Adopting CDISC Standards: Our Journey With CDISC

CDISC, Certara Products, Certara Products - Pinnacle 21, Data Standards, pre-update, Case Study

Inferring Target Occupancy for Pembrolizumab

Modeling and Simulation - QSP, Quantitive Systems Pharmacology (QSP), Case Study

Asciminib – PBPK Modeling Streamlines Development and Avoids Over 10 Clinical Trials

Certara Products - Simcyp, Modeling and Simulation - PBPK, Case Study

Optimizing Clinical Development: Saving Time and Costs

Biologics, Bispecifics, Immuno-oncology, Modeling and Simulation - QSP, TCE, Therapeutic Specialties, Case Study

Medicines that matter: Biohaven’s Nurtec™ drug development journey

Case Study LP - featured, Case Study Resources - Featured, Central Nervous System (CNS), Clinical Pharmacology, Pharmacometrics, Therapeutic Specialties, Case Study
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