Despite increased regulatory support for pediatric drug development, sponsors still face ethical, economic and practical constraints. Indeed, while children represent about 40% of the world’s population, only 10% of the drugs on the market have been approved for pediatrics. Children are not small adults, and all children are not the same. In particular, children under … Continued
Speaker Lora Killian provides insight on how EMA Policy 0070 will affect your organization and how to facilitate compliance, addressing many critical transparency and disclosure issues.
PRINCETON, NJ – Feb. 22, 2017 – Certara today announced that the Standards Council of Canada (SCC) has awarded Good Laboratory Practices (GLP) certification to its Certara Strategic Consulting (CSC) Montreal facility.
The current version of the database includes clinical safety and efficacy information on all biologics as well as newer synthetic DMARDs currently approved or in development for rheumatoid arthritis (RA). Information on older treatment options (MTX and other DMARDs) was included if they are used as active controls.
The current version of the database includes clinical safety and efficacy information on treatment options currently approved or in development for Chronic Kidney Disease (CKD) progression
in patients with Type 2 Diabetes Mellitus (T2DM) and overt albuminuria/proteinuria, as well as patients with IGA nephropathy.
The current version of the database contains information from randomized controlled trails on all current biologic and small molecule drugs that are evaluated for moderate-to-severe Crohn’s disease in patients that failed conventional treatment.
The Quantify AS Clinical Outcomes Database is developed to document clinical safety and efficacy information from randomized controlled trials investigating biologics currently approved or in development for ankylosing spondylitis (AS).
The Quantify Acute Lymphoblastic Leukemia (ALL) Clinical Outcomes Database documents clinical efficacy information in infants, children, and adults following salvage treatment for relapsed/refractory patients.
The current version of the database includes clinical safety and efficacy information on all symptomatic drugs as well as newer Abeta drugs currently approved or in development for Alzheimer Disease (AD).
One of the most challenging aspects of population pharmacokinetic/pharmacodynamic (PK/PD) modeling is the lack of computing power required to solve complex models in a reasonable time frame to support rapid drug development decisions. The explosion of cloud computing resources has provided access to significant computing power to solve these complex models. However, accessing these cloud … Continued
