If you’ve heard about eCTD authoring template suites before, but you’re not sure what they do or whether they would be beneficial to your pharmaceutical company or CRO, you’ve come to the right place. Here I will explain what an...
In this webinar, Dr. Ioannis Loisios-Konstantinidis from Novartis, Switzerland discussed: Opportunities and challenges in conducting virtual bioequivalenceIVIVE-PBPK in biopharmaceuticsAn quantitative risk assessment approach for virtual bioequivalenceRole of inter-occasion variability and pharmacokinetic properties in virtual bioequivalence
Amongst the real world data sources in Europe, the French Healthcare database SNDS is the largest and potentially the most comprehensive healthcare data resource, covering ~65 million lives, more than 99% of the French population and about 10% of Europe....
Creating submission-ready regulatory documents that are consistent in presentation, appropriate in content, and formatted to be eCTD compliant the first time comes with its unique challenges. To address these challenges, Certara Synchrogenix paired its technical experts with its regulatory writers...
Amongst the real world data sources in Europe, the French Healthcare database SNDS is the largest and potentially the most comprehensive healthcare data resource, covering ~65 million lives, more than 99% of the French population and about 10% of Europe....
Amongst the real world data sources in Europe, the French Healthcare database SNDS is the largest and potentially the most comprehensive healthcare data resource, covering ~65 million lives, more than 99% of the French population and about 10% of Europe....
Amongst the real world data sources in Europe, the French Healthcare database SNDS is the largest and potentially the most comprehensive healthcare data resource, covering ~65 million lives, more than 99% of the French population and about 10% of Europe....
Safety issues account for about a quarter of the attrition in drug projects and can arise from either the primary or secondary pharmacology. To address secondary pharmacology, researchers typically screen their small molecule compounds against a broad panel of off-target...
The pharmaceutical has made massive investments in complex biologics, a drug class that includes oligonucleotide therapeutics, immuno-oncology therapies, vaccines, antibody-drug conjugates, bispecific antibodies, and cell and gene therapies. These drugs can be challenging to develop for multiple reasons. Certara provides...
Several clinical pharmacology considerations must be accounted for when developing drugs for NAFLD and NASH.
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