Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
|Articles|July 2, 2016
- Pharmaceutical Technology-07-02-2016
- Volume 40
- Issue 7
Data Integrity Solution Improves Quality and Compliance
The LabX from Mettler Toledo has the ability to connect different laboratory instruments to one management system.
The LabX from Mettler Toledo has the ability to connect different laboratory instruments to one management system. This ability to connect and archive data assists in eliminating administrative bottlenecks and the risk of transcription and recalculation error in manual processing. LabX helps to ensure that all data produced by lab equipment meet fundamental quality elements and criteria for scientific soundness to meet GMP 21 CFR 211. By allowing analytical instruments to send data electronically, the process of data generation, plausibility checks, and data transfer is automated. LabX provides automatic results evaluation and stores complete data sets, including meta data for later reference and use.
Articles in this issue
over 10 years ago
FDA and Manufacturers Intensify Concerns about Data Integrityover 10 years ago
Planning a Biologics Facility Start Upover 10 years ago
Solid-Dosage Packaging Trendsover 10 years ago
Quality System for a Regulatory Affairs Departmentover 10 years ago
Data Integrity Challenges in Manufacturingover 10 years ago
Bio/Pharma Funding Challenges Could Hurt CDMOs in 2017over 10 years ago
Cleaning Bioreactors and Fermenters with CIP Systemsover 10 years ago
Maximize Efficiency in Tooling Maintenanceover 10 years ago
Recognizing Pharma Industry Excellenceover 10 years ago
Expanding the Chiral ToolboxRelated to this article
Sanjay Konagurthu, PhD, senior director of Science and Innovation at Thermo Fisher Scientific, explains what teams need to do to ensure the usefulness of AI and what strides have been made with AI in regulatory submissions.
Pauric Bannigan, Intrepid Labs, explains where AI speeds formulation decisions, why data is the bottleneck, and how active learning trains models with far less data.
The new initiative aims to apply traceable AI and science to expand care worldwide by translating discovery into tools that accelerate drug development.
Sanjay Konagurthu, PhD, senior director, Science and Innovation at Thermo Fisher Scientific, provides an update on the progress of AI and machine learning used in drug delivery.
Stephanie Johnson, Pfizer, explains how off-platform triggers, single-owner risk registers, and traceable prior knowledge keep protein formulation programs on track.
Stephanie Johnson, Pfizer, discusses how platform formulations moved 2 Pfizer protein programs to IND in 8 months by redistributing, not removing risk.
Shubhajit Paul, a senior research fellow in Boehringer Ingelheim’s Department of Material Analytical Sciences, spoke with PharmTech at AAPS PharmSci 360 to explain how tabletability prediction can be improved for roller-compacted formulations.
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