Sat.Jul 02, 2022

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Application of RSD Charts for Content Uniformity Data in Continued Process Verification

PharmaTech

This article is focused on introducing a control chart technique using relative standard deviation (RSD) statistics (i.e., RSD chart); in other words, a coefficient of variation chart for continued process verification.

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Treatment with Ofatumumab Increases Number of Patients Who Achieve No Evidence of Disease Activity for MS

Pharmacy Times

New data show that after 4 years of treatment, 78.8% of patients who continuously received ofatumumab achieved no evidence of disease activity-3 (NEDA-3) compared to 51.8% of those who switched from teriflunomide to ofatumumab.

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Automating Biopharma Manufacturing

PharmaTech

Automation and digitalization work together in the digital plant.

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Formulating Biologics: A Learning Curve

PharmaTech

Biologics are forming a greater proportion of the development pipeline, but there are still some formulation difficulties to overcome to ensure clinical and commercial success.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Bottoms Up! Research into Bowel Cancer Therapies Gain Funding Boost

PharmaTech

Dame Deborah James’ legacy and the millions raised through her campaigning will undoubtedly be a big boost to clinical research, ultimately providing new and promising treatments for bowel cancer patients.

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The Difference between Electronic Records Retention and Archiving

PharmaTech

An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.

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FDA Advances Quality Initiatives to Combat Drug Shortages

PharmaTech

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

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Robotic Injectable Drug Processor

PharmaTech

Steriline’s Robotic Nest Filling Machine is designed to minimize human intervention in aseptic processing of injectable drugs.

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Innovations in Single-Cell Proteomics Drive Advances in Disease Research

PharmaTech

Single-cell analytical technologies can deepen the understanding of cell biology and, therefore, disease mechanisms.

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Trends in International Arbitration: The Fallout from COVID-19

PharmaTech

As a result of the disruptions caused by the COVID-19 pandemic, global arbitration has adapted to a ‘new normal’.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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The European Union’s New Pharmaceutical Strategy for Europe

PharmaTech

A new strategy aims to bring in legislative reforms that will impact medicinal product regulation within Europe.

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Getting Proactive with Pharma Packaging

PharmaTech

Technological advances are progressing pharmaceutical packaging to overcome the challenges of the future.

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Material Management and the Impact on Extractables and Leachables

PharmaTech

By understanding potential material change, the impact on patient safety can be understood and mitigated.

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Process Development Struggles with Molecular Diversity

PharmaTech

As we reach further afield in the molecular universe, we encounter new types of problems to resolve.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Advancing Accessibility through Point-of-Use Manufacturing

PharmaTech

Point-of-use manufacturing may lead to a big change in the accessibility of medicines globally.

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Challenges to Formulation Development for Highly Potent APIs

PharmaTech

Lack of toxicity data and poor physicochemical properties must be overcome.

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What is Wrong with the Neuroscience Drug Market?

PharmaTech

Pharma should expand on successful cell therapies in oncology by applying these development and manufacturing methods to neuronal cell therapies.

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Fully Enclosed Mixing/Melting System

PharmaTech

The ROSS Mixing/Melting and Holding Tank System can generate up to 10 psig internal pressure to produce potent and reactive materials.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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How Can We Come Up Short So Often?

PharmaTech

Systemic inefficiencies in the pharmaceutical industry undermine problem-solving efforts.

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Prefilled Syringes Show Strong Growth

PharmaTech

Demand spurs innovations in syringes and syringe fill/finish operations.

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Aseptic Tubing Connector

PharmaTech

The AseptiQuik G DC connector is a single, sterile connection technology that can connect and disconnect tubing aseptically.

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