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Brexit Impact on EudraCT Postings

The European Commission published a notice to stakeholders on September 6, reminding pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including the submission of clinical trial information to EudraCT. The submission of certain clinical trial information to the European Union (EU) database is a provision of an EU law which will no … Continued

Improve Your Approach to Sharing Clinical Trial Data

Transparency and disclosure of clinical trial data has been a hot topic, growing in prominence and strategic discussions over the past few years. Disclosing clinical trial information and creating transparency around clinical trial results are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur … Continued

Understanding CTIS: Europe’s New Clinical Trial Information System

After almost twenty years with EudraCT, it’s time to say goodbye to Europe’s old clinical trial database and embrace the new Clinical Trial Information System (CTIS). CTIS will be the single-entry point for submitting, assessing, authorizing, supervising, and reporting a clinical trial in all Member States of the EU (Figure 1). It will be used … Continued

Ministry of Health of Ukraine Order 1528 for Public Release of Trial Results

By Nirpal Virdee, Global Head of Transparency & Disclosure  Over the past several years, Ukraine has taken significant steps with its healthcare services in hopes of matching the high quality, modern healthcare provided in leading western countries. The Ministry of Health (MoH) of Ukraine continues to invest heavily in this ambitious goal. New legislation in … Continued

3 Major Implications of New European Clinical Trial Regulations

Have you heard the buzz around the new European Union Clinical Trial Regulations (EU-CTR) for transparency and disclosure of clinical trial data? The goal of the EU-CTR is to create a more favorable environment for clinical research in Europe, as well as maintain the highest patient safety standards, and increased transparency of clinical trial information … Continued

Regulatory Writing Experts Can Make You a Lean, Mean Pharma Machine

Getting your body into shape has a lot in common with helping implement regulatory medical writing best practices at a biopharmaceutical organization. Specifically, there are a number of similarities between engaging a regulatory writing consultancy and hiring a physical trainer. Unlike “Hans and Franz” of Saturday Night Live fame, who just want to “Pump YOU … Continued

How to Navigate “EMA Policy 70: Publication of Clinical Data” and Ensure Compliance

The issue of transparency and disclosure of clinical trial data has been growing over the past few years. Clinical trials are essential in offering new therapies to patients. However, individuals participating in these trials put themselves at risk, and therefore, the medical community is obligated to derive as much benefit from that risk as possible. … Continued

Considering Age Variation When Coining Drugs as High Versus Low Hepatic Extraction Ratio

The hepatic extraction ratio (EH) is commonly considered an “inherent attribute” of drug. It determines the main physiological and biological elements of the system (patient attributes) that are most significant in interindividual variability of clearance. The EH consists of three age-dependent parameters: fraction of unbound drug in blood (fu.B), hepatic intrinsic clearance of unbound drug … Continued

Prediction of Intestinal First-pass Drug Metabolism

Despite a lower content of many drug metabolising enzymes in the intestinal epithelium compared to the liver (e.g. intestinal CYP3A abundance in the intestine is 1% that of the liver), intestinal metabolic extraction may be similar to or exceed hepatic extraction. Modelling of events on first-pass through the intestine requires attention to the complex interplay … Continued

Capturing Structure-activity Relationships from Chemogenomic Spaces

Modeling off-target effects is one major goal of chemical biology, particularly in its applications to drug discovery. Here, we describe a new approach that allows the extraction of structure-activity relationships from large chemogenomic spaces starting from a single chemical structure. Several public source databases, offering a vast amount of data on structure and activity for … Continued
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