How D360 platform helps your decisions for small molecule and biologic drug development and a preclinical translational research

9:00 am – 10:00 am CST (China Standard Time) Drug development requires understanding of complex chemical, biological, logical, and computational data from multiple data sources. Whether you are accessing data from a single source or need a more comprehensive enterprise data integration solution, the D360 toolkit and additional products provide you with the flexibility to … Continued

Understanding Key Components of a Clinical Evaluation

In 2016, the European Commission (EC) released MEDDEV 2.7/1 Revision 4 (MEDDEV) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, which was the first indication of sweeping regulatory changes that would occur in Europe affecting medical devices. This guideline was published and went into immediate effect without a transition … Continued

Simplify Your Submissions Review Process With an Anytime, Anywhere eCTD Viewer

Your organization has numerous stakeholders responsible for reviewing the content of your drug submissions which requires approving eCTD submission content quickly, fielding agency questions on the fly, and often entails referencing in-stream as well as historical submissions to do so. The trouble is, without the right eCTD viewing software in place, simple yet critical review … Continued

What does the Clin Pharm Plan for a Biologic Look Like?

Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and safe therapeutic solutions for patients. Due to their molecular and biological specificities, their clinical and pharmaceutical development present some particularities and challenges in comparison to the development of new molecular entities. Thanks to three decades of experience in the development … Continued

Thought Leadership Series: Leveraging FDA expedited review programs

August 25, 2021 at 2:00 p.m. ET The U.S. FDA offers four distinct programs to speed the development and availability of drugs that address an unmet medical need in the treatment of a serious or life-threatening conditions: Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy. Additionally, other programs, such as the Regenerative Medicine Advanced … Continued

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

Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate

The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing the Flame of a Healthy Debate” published in ASCPT’s CPT Pharmacometrics & Systems Pharmacology exposes the different perspectives around origin, use and ongoing advancement of modeling & simulation software for regulatory purposes. Concepts of quality, data reproducibility, model qualification (model … Continued

Small Molecules, Biologics, and Vaccines: Three Uniquely Divergent Roads to FDA CMC Approval

In chemistry, manufacturing, and controls (CMC) regulatory writing, there is a difference in the level of detail required for New Drug Applications (NDAs) and Biologic License Application (BLAs) supporting different types of products. The expectations tend to diminish as time elapses and the regulatory authority becomes more familiar with a specific type of medicinal product. … Continued

Plain Language Summaries & Patient Engagement in Pediatrics

Plain language summaries (PLS) of clinical trial results ensure that study participants are informed about study results and that they understand the value of their contribution to science and public health. Patient engagement is key to support PLS development. Factoring patient insights and experience into PLS development drives improvement of PLS quality, readability, and comprehension. … Continued

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