November 03, 2022
Cover Story
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Data analytics, modular equipment, digital tools, and risk-based validation improve speed, flexibility, and quality.
November 03, 2022
Peer-Reviewed Research
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Advancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.
November 03, 2022
Development
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High-concentration injectable formulations present unique challenges.
November 03, 2022
Development
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Opportunities and developments in particle engineering are providing developers with the tools to advance drug candidates successfully.
November 03, 2022
Manufacturing
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The state of oral solid dose manufacturing is influenced by new approaches, novel technologies, and the structural evolution of the raw materials market.
November 03, 2022
Manufacturing
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Adherence to detail and thorough project management are required for successful tech transfer and scale up.
November 02, 2022
Analytics
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Replacing a step in sample preparation with an automated approach improves both method precision and productivity.
November 02, 2022
Regulatory Watch
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The DGA seeks to increase trust in data sharing, strengthen mechanisms to make data more available, and overcome obstacles to the reuse of data, which are vital ingredients to the intersectoral use of health data.
November 02, 2022
From The Editor
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Industry and the government must work closely to ensure the UK remains a competitor in the clinical research field.
November 02, 2022
Outsourcing
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In this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.
November 02, 2022
Manufacturing
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Pharma companies set goals and adopt more sustainable alternatives.
November 02, 2022
Regulatory Watch
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FDA keeps its user fees but fails to gain important reforms.
November 02, 2022
Ask the Expert
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Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.
November 02, 2022
From The Editor
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Content is king in publishing, but interpretation is imperator.
November 02, 2022
Product Spotlight
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The ROSS VersaMix Multi-Shaft Mixers are designed for processing medium-to-high viscosity applications up to several hundred thousand centipoise.
November 02, 2022
Product Spotlight
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HeliFlex from Freudenberg Medical is a high purity TPE designed for biopharmaceutical fluid transfer applications.
November 02, 2022
Product Spotlight
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Akadeum’s Life Sciences isolation kit uses microbubbles to reduce leukopak production time.
November 02, 2022
Product Spotlight
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Evoqua’s Sophis digital services is a holistic monitoring and analysis solution for pharmaceutical water management.
November 02, 2022
From the CEO
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Next year's "FDA Voices" series will cover core topics FDA staff are prioritizing.