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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Conversations in Drug Development Trends

The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

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Deliberate Dysentery

Codon

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

Vaccine 108
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The Cost of Knowledge: Evaluating Open vs. Paid Data for Pharma

DrugBank

These data sources are known for being highly referenced and usable for specific research activities; further yet, a number of recognizable open sources, along with their identifiers, are considered industry standard resources. Paid Knowledge Bases Paying for access or licensing a knowledge base can be a difficult decision to make.

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New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

“Notably, the 70 percent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial. INDIANAPOLIS, Jan. Across 1,035 patients, there were 11 events (2.1