Tag: 希少疾患
6MWTにおける変動性を理解する：デュシェンヌ型筋ジストロフィー病態進行モデルの開発
Watch this webinar with Drs. Lora Hamuro and Joga Gobburu to learn how they developed a natural history progression model for DMD using the 6MWT.
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.
Using Model-informed Drug Development Approaches to Accelerate Orphan Drug Development
Orphan drugs are used to treat rare diseases and disorders. This year marks the 35th anniversary of both the landmark Orphan Drug Act, a law passed by the US FDA that created legal and financial incentives for pharma and biotech to pursue rare disease R&D, and the formation of the National Organization for Rare Disorders … Continued
The Modernization of Orphan Drug Development
Orphan drugs affect 350,000 people worldwide, including 10% of the US population and 1 in 25 Europeans. Model-informed drug development (MIDD) approaches, such as PBPK and PopPK have been embraced by sponsors and regulators, and play a key role in modernizing and accelerating orphan drug development.
Certara: A Proud Member of MDGH’s New Drug Application for River Blindness Team
PRINCETON, NJ – Dec. 20, 2017 – Certara today congratulated Medicines Development for Global Health (MDGH), a not-for-profit global health company, on the submission of its new drug application (NDA) for moxidectin as an oral treatment for river blindness (onchocerciasis).
Obeticholic Acid—From PK Model to Drug Label
Watch this webinar with Jeffrey Edwards to learn how he used physiologic pharmacokinetic modeling to understand the relationship between systemic and hepatic exposure of OCA in patients with and without hepatic impairment. By watching this webinar, you will learn how pharmacokinetic modeling can support optimal dosing for patients with organ impairment and facilitate regulatory approval.
Population Pharmacokinetic Modeling of Teduglutide to Support Dosing in Pediatric Patients with Short Bowel Syndrome
Changing the Game in Drug Development: A Selection from Certara’s Best of Blogs
A selection of short essays from our blog containing insights from our thought leaders on how modeling and simulation has impacted and is continuing to reshape our approach to drug development.
Certara’s Best of Blogs 2016
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.
