FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|July 2, 2021
- Pharmaceutical Technology, July 2021 Issue
- Volume 45
- Issue 7
Airborne Particle Counter
The Lasair Pro Airborne Particle Counter from Particle Measuring Systems is designed to meet data Integrity and regulatory requirements.
The Lasair Pro Airborne Particle Counter from Particle Measuring Systems supports a range of applications including clean area monitoring and classification while meeting international cleanroom certification standards.
The instrument is designed to meet increasing data Integrity and regulatory requirements, featuring integrated audit trail capabilities.
Sampling activities can be programmed and managed locally or remotely. Collected data are securely saved and transferred to meeting data integrity-related standards such as 21 Code of Federal Regulations Part 11.
The instrument can store up to 10,000 data samples and can be configured for up to 100 users. An NFC card can be used for unlimited users.
Articles in this issue
over 5 years ago
Complex Biomolecules Require Analytical Evolutionover 5 years ago
Meeting Future Analytical Requirements for Novel Biotherapeuticsover 5 years ago
Subunit Vaccines and the Fight Against COVID-19over 5 years ago
Formulating Tablets Layer by Layerover 5 years ago
Innovations Meet Growing Demand for Prefilled Syringesover 5 years ago
Survey of QPs on Remote Certificationover 5 years ago
Assessing Legacy Drug Qualityover 5 years ago
Considering Annex 1 Revisions: Expert InsightsRelated to this article
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.
Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Jane Zhang of ETCH Sourcing explains why geopolitics, transparency, and partnership now weigh as heavily as cost and quality when companies choose suppliers, in this episode of Ask the Expert, moderated by Susan J. Schniepp of Nelson Labs.
Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
Jaenisch, Muraru, and Pandey discuss new skills for QC and regulatory teams, plus patient trust, as new approach methodologies reshape pharma.
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