Optimal use and distribution of coronavirus disease 2019 (COVID-19) vaccines involves adjustments of dosing. Due to the rapidly evolving pandemic, such adjustments often need to be introduced before full efficacy data are available. As demonstrated in other areas of drug...
It is crucial for biotech developers to engage in early commercial market assessment to generate value for Regulators, Payers, and Clinicians. This approach should be integrated with a clinical development strategy that will help drive acquisition potential, co-development prospects, and...
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• The predictive performance of physiologically based pharmacokinetic(s) (PBPK) models for PK in renal impairment (RI) and hepatic impairment (HI) populations was evaluated using clinical data from 29 compounds with 106 organ impairment study arms were collected from 19 member...
PK Submit automates the time consuming, error-prone and complex task of creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions. It allows you to automatically create a complete electronic regulatory submission-ready package within minutes during the...
By Professor Piet van der Graaf, Ph.D., and Hugo Geerts, Ph.D. Neurodegenerative diseases (NDs) affect millions of people worldwide. In the US alone, five million people suffer from Alzheimer disease; 1 million from Parkinson disease; 400,000 from multiple sclerosis (MS);...
Certara's eCTD review software streamlines the regulatory submission review process to facilitate timely reviews of eCTD submissions.
GlobalSubmit PUBLISH eCTD publishing software is designed to simplify the process of creating & submitting eCTDs to regulatory agencies.
Hear our experts speak about the Direct Use of AI in Clinical Regulatory Document Development: Real-World Use during DIA MASC 2024.
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