Everything You Need to Know About SDTM
Find out all you need to know about CDISC SDTM, from the SDTM implementation guide to a step-by-step process for SDTM dataset creation.
Tag: 医薬品開発
Blueprint for pandemic response: Focus on translational medicine, clinical pharmacology and pharmacometrics
Perhaps the most important lesson learned from the COVID‐19 pandemic is that of preparedness. Enhanced surveillance systems for early threat detection will be crucial to maximizing response time for implementation of public health measures (…)
Scientists work toward an elusive dream: a simple pill to treat Covid-19
By Damian Garde The world has vaccines that can prevent most cases of Covid-19. It even has drugs that can help with the most serious symptoms of the disease. Now what it needs is a Tamiflu for SARS-CoV-2. It would be a pill, exquisitely (…)
Combining APIs: MPT Development & Regulatory Considerations
This third webinar in the “Let’s Talk MPTs” discussion series will provide MPT product developers and other stakeholders an overview of clinical development and regulatory considerations when developing products that combine one or more active ingredients into an MPT product. Speakers Dr. Virna Schuck, PhD is Senior Director of Clinical Pharmacology at Certara and has over 16 years … Continued
Purity is a Virtue: 不純物報告に関する実践ガイド
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
Certara Senior Executive Inducted as Fellow of the Royal College of Physicians
UK fellowship honors people who have made significant contributions to the practice or science of medicine PRINCETON, NJ.— 2021年1月28日 – Certara, Inc., the global leader in biosimulation, today announced that Craig Rayner, Pharm.D., MBA, has been inducted as a fellow of the Royal College of Physicians of Edinburgh in Scotland. Dr. Rayner is … Continued
Chemistry World: 脳により良い治療を
Major pharmaceutical companies have long been downsizing their central nervous system (CNS) research and development programmes. Between 2009 and 2014, there was a 52% drop in CNS drug discovery and development programmes pursued by large pharma, with almost all companies showing a decline. That situation has continued, despite great unmet needs remaining in mental health and other … Continued
Scientific Computing World: COVID-19の医薬品開発における核となるソフトウェア
ACRP: Researchers Urged to Add to Knowledge of COVID-19’s Course in Children and Pregnant Women
BioWorld: COVID-19 drug development: Optimizing activity during the worst of times
At the best of times, drug development is, of course, a complex problem. It is all the more demanding still in the middle of a pandemic, when the threat to human life is increasing exponentially, and health care systems are buckling under an extraordinary burden. Optimizing the development of drugs and vaccines in order to … Continued
