pre-update Archives

Publication

Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling

While the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration…

CertaraJuly 21, 2023

Blog

Simcyp™ Compound Summaries Library: What is it & why should you use it?

In the world of pharmacokinetic/dynamic (PBPK/PD) modelling, compound PBPK models are incorporated into compound files…

CertaraJuly 21, 2023

On-Demand Webinar

RAPS Sponsored Webcast: How to Plan for a Successful EMA Policy 0070 Submission

In September 2023, the European Medicines Agency (EMA) will reinstate their Policy 0070 requirement to…

CertaraJuly 20, 2023

Blog

Change Management – An Important Part of Good Manufacturing Practice (GMP)

You are having a good day as a quality assurance professional at a small pharmaceutical…

CertaraJuly 14, 2023

Press Release

Certara to Report Second Quarter 2023 Financial Results on August 9th, 2023

PRINCETON, N.J.— July 13, 2023-- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today…

CertaraJuly 13, 2023

Poster

Exploring Amyloid Antibodies Treatment Guidelines in Alzheimer’s Disease Using A Quantitative Systems Pharmacology Approach

CertaraJuly 12, 2023

On-Demand Webinar

AAPS eChalk talk: FDA Modernization Act – What Does it Mean for Pharmaceutical Scientists?

Historically, the FDA has required drug discovery and development programs to include animal testing. With the…

CertaraJuly 12, 2023

Brochure

Introduction to compound summaries and overview of the Simcyp™ compound library

CertaraJuly 11, 2023

White Paper

Understanding the Impact of FDA Modernization Act 2.0 on Drug Development

Learn how the FDA Modernization Act 2.0 will change the drug development landscape by allowing…

CertaraJuly 6, 2023

On-Demand Webinar

How QSP brings insights and accelerates bispecific antibody drug development

Wednesday, August 9th 2023 More than 50 bispecific antibodies are in oncology clinical development with…

CertaraJune 29, 2023

pre-update

Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling

Simcyp™ Compound Summaries Library: What is it & why should you use it?

RAPS Sponsored Webcast: How to Plan for a Successful EMA Policy 0070 Submission

Change Management – An Important Part of Good Manufacturing Practice (GMP)

Certara to Report Second Quarter 2023 Financial Results on August 9th, 2023

Exploring Amyloid Antibodies Treatment Guidelines in Alzheimer’s Disease Using A Quantitative Systems Pharmacology Approach

AAPS eChalk talk: FDA Modernization Act – What Does it Mean for Pharmaceutical Scientists?

Introduction to compound summaries and overview of the Simcyp™ compound library

Understanding the Impact of FDA Modernization Act 2.0 on Drug Development

How QSP brings insights and accelerates bispecific antibody drug development

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