On-Demand Webinar Archives

On-Demand Webinar

What Oncology Drug Developers Should Expect from the FDA’s Project Optimus

Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This…

CertaraJanuary 13, 2022

On-Demand Webinar

PBPK Modeling of Antibody-Drug Conjugates – Concept and Application

Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a…

CertaraJanuary 13, 2022

On-Demand Webinar

Certara University Express Webinar: Part 2: Introduction to RsNLME and overview of expanded workflow

Introduction to RsNLME and its capabilities for population PK/PD modeling.

CertaraJanuary 5, 2022

On-Demand Webinar

Certara University Express Webinar: Part 1: Introduction to RsNLME (R speaks NLME)

Introduction to RsNLME and its capabilities for population PK/PD modeling.

CertaraJanuary 5, 2022

On-Demand Webinar

Strategic Application of PBPK Modeling for Predicting DDIs & the Effects of Smoking & Organ Impairment

Olanzapine is a highly effective antipsychotic, but its uses are limited by the risk of…

CertaraDecember 23, 2021

On-Demand Webinar

Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3

On November 29th 2021, CDISC released updated versions of SDTM and ADaM, including standardized structures…

CertaraDecember 16, 2021

On-Demand Webinar

Predicting and Taming Immunogenicity: Strategies for your Biologic Drug

Immunogenicity is the ability of a foreign substance, such as a drug or vaccine, to…

CertaraNovember 19, 2021

On-Demand Webinar

External Control Arms – The Case for a Standardized Lexicon and Toolkit

Both the FDA and EMA have made statements that support the concept of using real…

CertaraOctober 12, 2021

On-Demand Webinar

Model-based DDI Extrapolation Strategy from Adults to Children – A Case Study with Risdiplam

Risdiplam (EVRYSDI) is approved for the treatment of patients with spinal muscular atrophy ≥ 2…

CertaraOctober 7, 2021

On-Demand Webinar

FDA’s Digital Transformation: The Future of Technology and How to Prepare

As Life-Science manufacturers embrace new technologies to speed time to market and products become more…

CertaraOctober 5, 2021

On-Demand Webinar

What Oncology Drug Developers Should Expect from the FDA’s Project Optimus

PBPK Modeling of Antibody-Drug Conjugates – Concept and Application

Certara University Express Webinar: Part 2: Introduction to RsNLME and overview of expanded workflow

Certara University Express Webinar: Part 1: Introduction to RsNLME (R speaks NLME)

Strategic Application of PBPK Modeling for Predicting DDIs & the Effects of Smoking & Organ Impairment

Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3

Predicting and Taming Immunogenicity: Strategies for your Biologic Drug

External Control Arms – The Case for a Standardized Lexicon and Toolkit

Model-based DDI Extrapolation Strategy from Adults to Children – A Case Study with Risdiplam

FDA’s Digital Transformation: The Future of Technology and How to Prepare

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