Tag: 医薬品開発
Pharmacokinetic/ Toxicokinetic Services
As your partner for drug development and regulatory strategy, Certara has expanded its services to offer GLP-compliant pre-clinical PK/TK NCA analysis and reporting.
Certara Acquires Analytica Laser, a Leader in Market Access, Health Economics and Outcomes Research (HEOR), and Real-world Evidence Solutions
PRINCETON, NJ – Apr. 12, 2018 – Certara today announced that it has acquired Analytica Laser, a global research consultancy that uses health economics and outcomes research (HEOR) and real-world data to provide the highest level of scientific evidence of the value of medicines and health technologies.
Certara 2017年のベストブログ
A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.
医薬品開発の大変革
当社 Certara はイノベーターとして、当社のお客様の新薬開発や、アンメット・メディカルニーズへの対応、既存治療法の異なる患者集団への展開、規制対応の成功とマーケット・アクセスそれぞれの観点からの科学的情報の説明、リスク・ベネフィットプロファイルの最適化、競合環境における治療法の差別化、さらには何百万ドルという研究開発 (R&D) 費の削減などの支援に注力しています。
Certara Introduces New Investigator Awards Program in Australia
PRINCETON, NJ – Dec. 8, 2017 – Certara announced that Leigh Farrell, PhD, Vice President of Corporate Strategy and Business Development, is presenting the inaugural Certara New Investigator Awards in association with the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT).
Value-focused Drug Development Strategies of the Future
Mounting healthcare and R&D costs, high drug attrition rates leading to decreased numbers of new molecular entity approvals, and growing demands from regulators and payers indicate that a paradigm shift is needed to improve efficiency and productivity across the drug development continuum.
Certara-Monash University Industry Fellowship Program Receives Funding from MTPConnect
MELBOURNE, AUSTRALIA – 2017年10月26日 – MTPConnect today announced it will provide provisional funding to the Certara-Monash University Industry Fellowship Program over two years, with proposed matched funding coming from Certara.
医薬品研究開発における新たな問題：A Practical Approach for Pediatric Drug Programs
In this webinar, Dr. Barry Mangum from Paidion Research and Dr. JF Marier from Certara discussed how pediatric considerations fit into the overall drug development program. They also made recommendations for addressing issues from both a practical and scientific perspective. Anonymized case studies were presented with a review of historical issues with a focus on solutions for today (ie, licensed comparators differences in US and EU, importation issues, and endpoint selection).
