The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).
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Former MHRA inspector Rachel Carmichael discusses outsourcing areas of your quality system including what would drive this decision, aspects of the operation that can be supported and measures to facilitate the process
This article delves into four health technology assessment agencies, analysing the opportunities and challenges for orphan drugs in France, Germany, England and Scotland.
NICE has decided to not recommend Mayzent (siponimod) for use on the NHS as a secondary progressive multiple sclerosis treatment because its clinical trial did not directly compare it to interferon beta-1b.
Learn why Ozonia MEMBREL electrolytic ozone technology is the ultimate solution for ultrapure water disinfection applications.
Learn the benefits of Ozonia MEMBREL electrolytic ozone technology in ultrapure water disinfection applications.
How implantable systems and microparticle depot injections are meeting the needs of long-acting drug delivery
Implantable systems and microparticle depots are used in many areas of drug delivery to release medicines at a controlled rate within the body. The use of these long-acting dosage forms eliminates the need for frequent administrations via traditional routes of administration, which ensures patient compliance and results in improved outcomes.…
Since making its debut in the pharmaceutical setting, the range of applications for which Raman microscopy imaging has been used continues to grow. Here, Harald Fischer, Damon Strom, Miriam Boehmler, Eleni Kallis and Thomas Dieing demonstrate the versatility of confocal Raman imaging by exploring a variety of real-world applications.
The impact of rapid microbiological methods (RMM) on the scientific community has been widespread and profound. Lucpah Nekati explains how their numerous benefits enable deeper understanding, faster and more easily.
Application note: Pharmaceutical analysis using UV-Vis: compliance with USP Chapter <857> and European pharmacopoeia (Ph. Eur. Chapter 2.2.25)
USP general chapter and Ph. Eur. chapter 2.2.25 guide instrument operational qualification protocols for UV-Vis spectroscopy. This technical note demonstrates how to ensure qualification as per global pharmacopoeias' requirements.
GW Pharmaceuticals's Epidyolex (cannabidiol) has been changed from a Schedule 2 drug to a Schedule 5 drug, making it exempt from virtually all controlled drug requirements.
Analytical procedures are necessary to develop products and manufacturing process, to measure critical quality attributes and to ensure the quality of final products.
bioBoaVista showcases its viral transport medium, that can stabilise samples, for efficient nasal tests for the diagnosis of COVID-19.
A new consortium has been formed for the study of COVID-19 vaccines after their approval, to monitor their safety and efficacy.
After nitrosamines were detected in sartan medicines, the EMA has released new recommendations about handling and reporting impurities in drugs.