PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking

This webinar was presented on June 30, 2021 by David R. Taft, Ph.D. Professor, Pharmaceutics, Long Island University, NY, USA. Here is a summary of his presentation: • Tizanidine is an alpha2-adrenergic agonist, used to treat spasticity associated with multiple sclerosis and spinal injury. Tizanidine is primarily metabolized by CYP1A2 and is considered a sensitive … Continued

Combining active pharmaceutical ingredients (APIs): MPT Development & Regulatory Considerations

This fourth webinar in the “Let’s Talk MPTs” learning 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 pharmaceutical ingredients (APIs) into an MPT product. Speakers • Deven Shah – Chemistry, Manufacturing, & Control (CM&C) Lead at Certara• … Continued

Three Pathways have emerged in Innovative Access Agreements

The days of simply determining the market demand for a new drug as a function of price and choosing the revenue or profit optimizing point are gone. In our new environment, an explicit rationale, the “value-based price” has become a prerequisite for enabling conversation with payers while policy-makers seem poised to limit the pricing corridors … Continued

Outcomes Based Agreements

The days of simply determining the market demand for a new drug as a function of price and choosing the revenue or profit optimizing point are gone. In our new environment, an explicit rationale, the “value-based price” has become a prerequisite for enabling conversation with payers while policy-makers seem poised to limit the pricing corridors … Continued

Pharmacometrics & Clinical Pharmacology FOMO: Why the Future of Research is in Africa

Use of clinical pharmacology and pharmacometrics approaches has become the gold standard for informing optimal dosing of investigational drugs in various patient populations. At the same time, the demand for clinical pharmacologists and pharmacometricians is outstripping the current supply of practitioners as well as the number of students being trained in these disciplines in North … Continued

De-risk your program with evidence-based secondary pharmacology insights

Safety issues account for about a quarter of the attrition in drug projects and can arise from either the primary or secondary pharmacology. To address secondary pharmacology, researchers typically screen their small molecule compounds against a broad panel of off-target receptors. The challenge is in interpreting the readouts to understand which receptor interactions will contribute … Continued

ASCPT Micro-Recruitment Session

Ever wondered what a career as a drug development consultant is like? In this session, Suzanne Minton, PhD, Director of Content Strategy interviewed Mark Lovern, PhD, Senior Vice President of Quantitative Science Services at Certara. Mark provided an overview of the software and services that Certara supports and discussed what it’s like to work as … Continued

Stakeholder perspectives: current and potential benefits

Amongst the real world data sources in Europe, the French Healthcare database SNDS is the largest and potentially the most comprehensive healthcare data resource, covering ~65 million lives, more than 99% of the French population and about 10% of Europe. Watch this short video by Nadia Quignot, Director, Decision Analytics & Real World Evidence at … Continued

Similarities and differences between SNDS and other claim databases

Amongst the real world data sources in Europe, the French Healthcare database SNDS is the largest and potentially the most comprehensive healthcare data resource, covering ~65 million lives, more than 99% of the French population and about 10% of Europe. Watch this short clip by Nadia Quignot, Director, Decision Analytics & Real World Evidence at … Continued

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