FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
|Articles|October 1, 2010
Pharmaceutical Technology Europe
- Pharmaceutical Technology Europe-10-01-2010
- Volume 22
- Issue 10
Quantitative open-access HPLC analysis: a new calibration approach
A novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high?performance liquid chromatography without having to prepare standards.
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A novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high‑performance liquid chromatography without having to prepare standards. The authors discuss the approach taken to develop the tool, its associated protocols and how it can be used to calculate data.
Articles in this issue
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Validating Single-Use Systemsabout 16 years ago
EGA Position On The EC's Proposal For A Falisifed Medicines Directiveabout 16 years ago
Green is the wordabout 16 years ago
Newsabout 16 years ago
The Pros And Cons Of Single-Use Systemsabout 16 years ago
Europe: A Future Leader in Vaccines?about 16 years ago
Developing A Quality Agreement Template For Single-Use Systemsabout 16 years ago
Online Monitoring Of Continuous Hot Melt Extrusionabout 16 years ago
An All-Round Excipient For Direct CompressionAdvertisement
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Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.
FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.
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Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
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