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Majority of metformin drugs have acceptable nitrosamine levels, finds study
With recalls on metformin products containing nitrosamines ongoing, a study suggests >80 percent of metformin APIs and final drug products are within safe limits.
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Regulation & Legislation
whitepaper
Executive summary: Building a patient centric clinical supply chain
Learn strategies to improve supply chain efficiency, reduce risk and respond to local, regional and global challenges.
news
Emergent destroyed almost 400mn COVID-19 vaccines due to quality issues, finds report
US Government investigation report suggests Emergent Biosolutions destroyed almost 400 million doses of COVID-19 vaccine and worked to conceal quality issues from the FDA.
whitepaper
ebook: Early drug development strategies for clinical success
Learn the benefits of collaboration between the pharmaceutical scientists and clinical supply services teams.
webinar
Implementing state of the art technology to characterise polysaccharide vaccines
12 May 2022 | By Bruker
In this on-demand webinar, experts will discuss state of the art technology to characterise polysaccharide vaccines and relative implementation in biopharma development and manufacturing.
whitepaper
Whitepaper: Data integrity and 21CFR.11 for 7000RMS implementation
Learn about 21CFR.11 and Annex 11 requirements and how you can implement a rapid bioburden analyser designed to meet compliant operation needs.
whitepaper
Article: Strategies for comparator sourcing
Best practices for leveraging the resources of sourcing vendors are vital to anticipating and avoiding clinical supply delays.
news
Fenfluramine found effective in preventing drop seizures from LGS
Phase III trial shows fenfluramine as an adjunct to existing anti-epileptic treatment is effective in reducing the frequency of drop seizures from Lennox-Gastaut Syndrome (LGS).
article
The latest on pharmaceutical counterfeiting
Here, EPR’s Hannah Balfour discusses the latest reports on pharmaceutical counterfeiting and falsification, exploring global and European crime rates, as well as recent counterfeiting incidents reported by Big Pharma.
video
On-demand webinar: Mould contamination, investigation and remediation challenges
Most industries face mould contamination issues, including medical products, hospitals, cosmetics, paint, among others. Learn more about mould and what you can do to combat it.
news
EMA’s human medicines committee (CHMP) April 2022 meeting highlights
At its latest meeting, EMA’s human medicines committee (CHMP) recommended the approval of four medicines, seven extensions of therapeutic indication and laid out recommendations for diabetes treatment outside of the EU.
whitepaper
Article: Choosing a CDMO for high potent manufacture
How to select a CDMO partner for the development and commercial manufacture, packaging and launch of products containing highly potent APIs.
article
European Pharmaceutical Review Issue 2 2022
Features in this issue discuss how bioprocessing must adapt to meet the needs of autologous cell therapies, the role of mass spectrometry in enhancing antibody consistency and the economic benefits of embracing continuous manufacturing. Also in this journal, articles exploring the development of precision medicine for chronic diseases, why acoustic…
news
Draft guidance to improve US clinical trial diversity
The new clinical trial guidance asks sponsors to submit a Race and Ethnicity Diversity Plan outlining how they plan to enrol participants from underrepresented populations.
news
CFD airflow stimulations can help enhance cleanroom contamination control, finds study
Researchers used computational fluid dynamics (CFD) simulations to assess their cleanroom airflow and suggest improvements that would reduce contamination levels.
