pre-update Archives

Blog

Stepwise PIPs: A Solution for the Challenges of Pediatric Drug Development

Early paediatric investigation plan (PIP) submissions – an unnecessarily bitter medicine? In the European Union…

CertaraApril 14, 2023

White Paper

Why Performing Key CMC Activities Early Can Aid De-risking Your Drug Development Program

This white paper focuses on best practices for developing a CMC strategy for orally administered…

CertaraApril 13, 2023

Video

Milestone Achieved: Simcyp 100

CertaraApril 11, 2023

Brochure

Drug Discovery & Development with Deep Learning Advanced Analytics

Solutions to Meet All Needs: From Small Biotech to Large Global Pharma

CertaraApril 6, 2023

Blog

Considerations for Pricing & Formulary Access for DRG-Funded Hospital Drugs

In the United States, treatments or medical services that require the patient be admitted into…

CertaraApril 6, 2023

Press Coverage

Using Quantitative Systems Pharmacology Modelling to Accelerate Drug Development

Model informed drug development (in silico modelling) continues to be a game changer in accelerating…

CertaraMarch 29, 2023

Press Coverage

Model-Informed Drug Development (MIDD) – EMA’s Advancement

Modelling and simulation (M&S) plays a crucial role in drug development. It allows information from…

CertaraMarch 29, 2023

White Paper

Advancing Biopharmaceutics & Drug Formulation Using In Silico Modeling

Model-Informed Formulation Development (MIFD) Increases Speed and Certainty for New and Generic Drugs

CertaraMarch 22, 2023

On-Demand Webinar

Data-Backed Trial Design– Applying AI to Clinical Outcome Analysis

Global spending on clinical trials is expected to reach $68.9 billion per year by 2025…

CertaraMarch 17, 2023

Fact Sheet

eCTD Templates – A Springboard to Submission Success

CertaraMarch 17, 2023

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