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PBPK for Drug-Drug Interactions (DDI)

Unlocking Efficiency in Drug Development with Simcyp PBPK Modeling  Complex drug-drug interactions (DDIs) are a significant roadblock in drug development. While crucial for safety, traditional methods like extensive clinical trials can be time-consuming, cost millions of dollars, and delay the delivery of potentially life-saving treatments to patients in need.  This white paper introduces Simcyp PBPK … Continued

https://www.certara.com/white-paper/pbpk-for-drug-drug-interactions-ddi/

Define-XML

Automate creation of define.xml – without coding Define-XML is a mandatory part of your regulatory submission for SDTM, SEND and ADaM datasets. But preparing your define.xml files, dataset metadata, aCRF, and reviewer’s guide, is a time-consuming manual task. Many studies fail because of faulty define.xml files. So, you need to make sure your submission is … Continued

https://www.certara.com/pinnacle-21-enterprise-software/define-xml/

How Drug Discovery Tools Aid Pharma Decision-Making

Learn how drug discovery tools can help pharmaceutical industry professionals make more informed decisions based on robust data analytics

https://www.certara.com/blog/how-drug-discovery-tools-aid-pharma-decision-making/

The State of AI in In Silico Trials and Drug Development – The Practical Application of AI in QSP [APAC Webinar]

The proliferation of AI models and GPTs has revolutionized how the life sciences industry consumes information and uses it for accelerating and validating research. By leveraging GPTs, researchers can complete what would normally be weeks long literature review and data extraction tasks in a matter of minutes or hours. In this webinar, Certara’s experts will … Continued

https://www.certara.com/webinar/the-state-of-ai-in-in-silico-trials-and-drug-development-the-practical-application-of-ai-in-qsp-apac-webinar/

SEND Dataset Services for FDA IND Submissions

Cleansing, mapping, programming and QC of in-scope nonclinical study data are all critical pieces of the regulatory submission process for both FDA Investigational New Drug (IND) Applications and New Drug Applications (NDAs). Certara’s expert biostats programmers provide submission ready CDISC SEND datasets and supporting documentation; these services are often utilized by biopharma companies without dedicated … Continued

https://www.certara.com/services/send-dataset-services-for-fda-ind-submissions/

Workshop in Japan: Simcyp Biopharmaceutics – Recent Advances and Applications

The impact and acceptance of Physiologically-Based Pharmacokinetic (PBPK) modelling continues to exhibit strong growth within the pharmaceutical industry, and PBPK approaches are increasingly being advocated by regulatory agencies to streamline drug development. The US FDA has released its draft guidance on this in Oct 2020: ‘The Use of Physiologically Based Pharmacokinetic Analyses.’ PBPK or Physiologically-Based … Continued

https://www.certara.com/live-events/workshop-in-japan-simcyp-biopharmaceutics-recent-advances-and-applications/

Why Medical Writing Services Use Style Guides & Lexicons

Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content for drug development and regulatory submissions.

https://www.certara.com/blog/why-medical-writing-services-use-style-guides-lexicons/

Certara.AI: Real World Applications

Report Review & Literature Screening A pharmaceutical company receives large volumes of unstructured documents from CROs, partners and departments across the organization that hold valuable data related to product attributes and the manufacturing life cycle. Manually analyzing these documents requires 2+ employees and 1+ full day of work per project, impacting over 200 total days of productivity … Continued

https://www.certara.com/certara-ai-real-world-applications/
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