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Clinical Trials

Discovery & Development Clinical Trials

Cannabis Complex

| George E. Anastassov

How unravelling the complex chemistry of the cannabis plant can lead to new medicines

Business & Regulation Clinical Trials

Clinical Data Star

| Elisa Cascade

Sitting Down With Elisa Cascade, President of Data Solutions at DrugDev

Discovery & Development Biosimilars

The Power List 2017

We forge ahead to celebrate the fantastic individuals involved in bettering the pharma industry.

Manufacture Clinical Trials

Return of the Cells

| James Strachan

Can noise-induced hearing loss be treated by regenerating inner ear hair cells.

Manufacture Clinical Trials

Weeding Out Pain

| Stephanie Sutton

What does patient preference for pot over prescriptions mean for the pharma industry?

Manufacture Clinical Trials

The Human Challenge

| Adrian Wildfire

Human challenge studies could allow us to better predict vaccines' real-world efficacy.

Discovery & Development Clinical Trials

Parents Pass Placebos

| James Strachan

Is it ethical to use placebo controls in pediatric clinical trials?

Discovery & Development Standards & Regulation

CAR-T Tragedy

| James Strachan

More deaths in a cancer immunotherapy trial raise questions over CAR-T safety

Discovery & Development Business Practice

Use of microcalorimetry and its correlation with Size Exclusion Chromatography for rapid screening of the physical stability of large pharmaceutical proteins in solution

Learn how to use DSC to screen for physical stability of proteins in solution. The utility of microcalorimetry as a rapid screening tool for assessing the solution stability of high molecular weight pharmaceutical proteins was evaluated using model recombinant antibodies, Protein I and Protein II. Changes in the transition midpoint, Tm, were monitored as a function of pH and/or in the presence of excipients, and results were compared with traditional accelerated stability data from samples that were analyzed by size exclusion chromatography (SEC). The data from microcalorimetry were well correlated with those from SEC for predicting both optimal solution pH as well as excipient effects on solution stability. These results indicate that microcalorimetry can be an efficient screening tool useful in identifying optimal pH conditions and excipients to stabilize pharmaceutical proteins in solution formulations.

Discovery & Development Clinical Trials

Efficacy vs Effectiveness

| William Aryitey

Tightly controlled trials are poor predictors of real-world outcomes


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