The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, “ANDA Submissions – Content and Format” is intended to assist applicants in preparing complete and fileable abbreviated new drug applications (ANDAs) for submission to FDA. The primary purpose of this guidance is to … Continued
Anticipate risks and preview the range of expected results before millions in R&D dollars are spent and human subjects are exposed to experimental therapies.
PRINCETON, NJ – Sept. 26, 2018 – Certara announced today the launch of its BaseCase Portal cloud-based platform, that allows for the rapid creation of fully-customizable mobile apps that connect live to mathematical models and algorithms, and help HCPs optimize treatment for individual patients.
Watch this webinar to learn how RSABE for NTIDs can be performed in Phoenix WinNonlin using a reusable template.
The European Commission published a notice to stakeholders on September 6, reminding pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including the submission of clinical trial information to EudraCT. The submission of certain clinical trial information to the European Union (EU) database is a provision of an EU law which will no … Continued
近年の医薬品開発では、開発失敗のリスクや不確実性の増大に加えて、開発費用も膨張を続けており、その複雑性はますます増大しています。 そのため、定量的手法とレギュラトリーサイエンスに基づく戦略策定の重要性がより高まっています。当社のソリューションにおける戦略評価の最初のステップは、ギャップ分析とロードマップ作成です。Over the last couple of months, I’ve written a series of blog … Continued
PRINCETON, NJ – Sept. 13, 2018 – Certara announced today that it has acquired Pirana, a widely used product for connecting and organizing pharmacometric modeling results as well as providing interfaces to a range of software tools used in pharmacometrics modeling.
The minimum and optimal recommended hardware requirements are shown in this document. Optimal hardware requirements are recommended for ideal application performance with
large datasets and projects.
デュシェンヌ型筋ジストロフィー (DMD) は致死性の伴性劣性遺伝性の小児希少疾患であり、通常男児のみ発症します。進行性の筋変性、筋力低下をきたし、最終的には機能損失につながるのが特徴です。DMDは、筋肉の統合性の維持、および筋組織の分化を促すシグナルと成長の促進に必要なタンパク質である、ジストロフィン遺伝子の変異が原因となり発症します。… Continued
This webinar focused on the impact of RI on substrates of organic cation transporter 2 (OCT2), one of the major renal transporters which has been shown to be affected—both in activity and expression—in RI in pre-clinical species and in vitro systems.
