Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
News|Articles|October 15, 2020
- Pharmaceutical Technology-10-15-2020
- Volume 2020 eBook
- Issue 3
Resources, Guidelines, and Guidance Documents
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
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Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
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Articles in this issue
almost 6 years ago
Enhancing Process Validation for Solid Oral Dosage Forms: Part 2almost 6 years ago
Due Diligence Assessment of CMC Activitiesalmost 6 years ago
Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?almost 6 years ago
Tackling Cybersecurity Challenges in Legacy Systemsalmost 6 years ago
Ending ‘Magical Thinking’ in Compoundingalmost 6 years ago
Viral Vector API Characterization of Product-Related Impuritiesalmost 6 years ago
Strong Quality Culture: A How-To for Busy Managersalmost 6 years ago
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This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.
In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
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Trending on Pharmaceutical Technology
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The FDA Finalizes Rule Recognizing Non-Animal Testing Methods, Building on Year-Long Reduction Push
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EU Clears AstraZeneca's Trixeo for Asthma, Opening New Manufacturing Demand for Single-Inhaler Triple Therapy
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Risk-Based Life Cycle Management of Master Production and Control Records to Strengthen Data Integrity and GMP Inspection Readiness Part 2: Practical Considerations for CGMP Documentation Systems
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Pharma Fundamentals: Digital Pathology in Drug Development, Part 1
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