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Exceling at Accelerating in Rare Disease Drug Development

By: Rajesh Krishna, PhD, FAAPS and Steve Sibley According to the National Institutes of Health, more than 30 million people in the United States are affected by a rare disease. Defined in the Orphan Drug Act as any disease that affects less than 200,000 people in the United States, rare diseases total more than 7,000 … Continued

Certara Hosts Seminar on Drug Discovery Challenges in Japan and How Modeling and Simulation Can Solve Them

“Quantitative decision-making with data rather than empirical thinking” – Certara’s Modeling & Simulation technology contributes to accelerate new drug development Certara G.K. held an online press seminar on 2022년 8월 31일 수요일, in Tokyo, on the optimization of the drug development process and the role of a drug discovery consulting company. In Japan, local demand … Continued

The Challenging Road to Developing an Integrated Platform for Drug Discovery and Precision Medicine Using the Power of Pharmacometrics

We have often seen Dr. Hwi-yeol (Thomas) Yun, Associate Professor/Adjunct Professor at the College of Pharmacy and Bio-AI Convergence Research Center of Chungnam National University, listed as a guest presenter at key Pharmacometrics conferences across the Asia-Pacific region, as well as at local Korean events. In 2020, he also presented to a large audience at … Continued

Getting Results Faster – Supporting Physicians and Pharmacists with Biosimulation Technologies

Certara’s Phoenix biosimulation software platform is widely used for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and population PK analysis. Recently, we have seen how Certara software helps customers accelerate collaboration across their divisions and groups for better clinical results. Today, we interviewed Sun Hua, Associate Chief Pharmacist at Yijishan Hospital, Drug Evaluation Center, Wannan Medical College, … Continued

Certara Completes Acquisition of Pinnacle 21

Complementary technologies accelerate and help assure success in the drug development process Princeton, N.J., 10월 4, 2021 – Certara, Inc. 글로벌 바이오시뮬레이션 선두기업(Nasdaq: CERT), a global leader in biosimulation, today announced the completion of the previously announced transaction to acquire Pinnacle 21, a leading provider of SaaS solutions for clinical data fitness, regulatory compliance and submission readiness.  … Continued

Overcome Research Hurdles: Expert Guidance for Complex Generic Drug Development

Do expensive bioequivalence studies stall your generic drug pipeline? Unlock the secrets to streamlined generic drug approval with our expert-authored white paper. Discover how physiologically-based pharmacokinetic (PBPK) modeling can revolutionize your approach to demonstrating bioequivalence, especially for complex generics. Virtual Bioequivalence (VBE) leverages advanced computer modeling to simulate drug behavior in the body, offering a … Continued

Strategic Evidence & Value Communication Symposium

Join us on 2021년 4월 21일 수요일, from12:00 PM – 2:00 PM EDT for Certara’s first annual Strategic Evidence & Value Communication Symposium. Across two panel discussions, a host of Certara and industry experts will debate and explore various best practices to ensure effective communication of product value, as well as the expanded use of Real World Evidence to accelerate market access decision-making.

Purity is a Virtue: A Practical Guide to the Reporting of Impurities

Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and how to include them in their regulatory applications. This webinar is designed to increase the understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take away messages. We will start by defining the various … Continued

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