The Inflation Reduction Act (IRA), one of the key legislative achievements the Biden-Harris administration, aims to expand benefits and reduce costs for Medicare beneficiaries. Among its provisions, the IRA introduced…
Certara’s Dr. Fran Brown, Senior Vice President of Drug Development Science, is quoted in this WIRED article about the FDA’s recent rejection of Lykos Therapeutics’ proposed MDMA treatment for post-traumatic…
When it comes to efficient clinical study build, content is king. Most importantly: metadata content. Metadata is the building blocks of your study. It’s the forms, terminologies and datasets you…
aCRFs are a mandatory requirement of the FDA, and therefore a key submission deliverable for any clinical trial. Creating quality annotated case report forms (aCRFs) takes time and attention to…
Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic steatohepatitis (NASH) is one type of NAFLD. Individuals with obesity and type 2 diabetes appear…
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The FDA’s Project Optimus initiative aims to reform dose optimization and selection for oncology therapies to maximize the efficacy of a drug as well as the safety and tolerability. Quantitative…
Many companies in the life sciences industry are slow to adopt new technologies. This is often down to budget restrictions, greater operational burden, and uncertainty with meeting complex regulatory requirements. …
Strategic Mechanisticモデリングソリューションは、免疫療法のバイオテクノロジー企業が新規治療法の臨床開発を加速させるのに役立ちます。
RADNOR, PA – 2024年8月15日 – Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) はCERT), a global leader in model-informed drug development, today announced the launch of Phoenix™ version 8.5. Phoenix is the pharmaceutical…
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