news
FDA releases new guidance for drug and biological product data
The FDA has released new draft guidance: “Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”
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Data integrity
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Tirzepatide maintains AC1 and weight control in type 2 diabetes patients
The highest dose of tirzepatide led to an A1C reduction of 2.58 percent and reduced body weight by 11.7kg in Phase III study.
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Video: tec5USA Anti-Counterfeit Solutions by Spectral Engines
All-in-one Drug Anti-Counterfeit Solution for improved pharma product security and brand protection, brought to big pharma companies via tec5USA.
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Data integrity is a key concern with microbial methods, says expert
Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.
video
Video: Fast BET assay Setup – See it in Action
See how QC analysts can easily set up fully compliant 21-sample BET assays in 9 minutes with less than 30 pipetting steps.
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Video: Automation of endotoxin assays
Want easy automation of BET assays and high throughput? Watch the video to see fast BET assay setup with centripetal microfluidic automation.
whitepaper
Application note: TOC Reference Materials – Make vs. Buy?
Explore the cost comparisons, risk reduction, and increased support that arise when using Sievers Certified Reference TOC Standards.
whitepaper
Application note: USP <643> TOC limit changes
This application note addresses the TOC limit changes in USP for packaged water. The new limits account for varying container volumes.
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Beware of false Raman spectroscopy results, says study
A new paper reveals a potential source of errors in the Raman spectroscopy analysis of chiral molecules that could lead to significant data misinterpretations, and a potential method to fix it.
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Worksheet: ARMM technology comparison
This worksheet can be edited to include specifications discovered during your evaluation of Alternative Rapid Microbiological Method Technologies.
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ICMRA set out recommendations for AI regulation in medicine
The ICRMA has set out recommendations to help regulators tackle the challenges posed by artificial intelligence (AI) in medicine.
video
On-demand webinar: The art of changing QC testing methods
Learn how you can go about changing QC test methods and how this can go a long way to helping your lab achieve data integrity compliance.
webinar
Improve efficiency and return on investment by adopting molecular spectroscopy techniques in pharma manufacturing
3 August 2021 | By Thermo Fisher Scientific
In this on-demand webinar, discover the differences between FTIR, NIR and Raman spectroscopy, learn how spectroscopy is applied in quality control labs and hear how implementation of these techniques increased efficiency and minimised costs.
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Case study: RMM to reduce plate counts
See how a pharma company maintained product quality and reduced risk by using an RMM analyser, while also meeting their goal of reducing plate counts by 25 percent.
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Case study: RMM for identifying contamination sources
See how a leading biopharma company used an RMM analyser in parallel to plate counts to find the root cause of periodic bioburden excursions in its water system.
