Formulation Development Featured Articles
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New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies
5/16/2024
The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.
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The EU’s Ban On TiO2 In Food May Impact Pharma. Here’s What You Should Know.
4/18/2024
Titanium dioxide (TiO2) is used as a food additive and OSD pharmaceutical excipient. In 2020, the European Food Safety Authority noted data gaps regarding particle size, which can affect its toxicological properties, so the European Commission banned it as a food additive. Here's how this could impact pharma.
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Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms
4/16/2024
Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more.
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Modeling Complex Human Immune Response In A Novel Intestine-Chip
4/9/2024
Learn about immune cell recruitment, why it is important when researching inflammatory bowel disease (IBD) and other diseases, how Organ-Chips benefit IBD research, and more.
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2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
4/9/2024
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
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Beyond mAbs: Level Up Your Knowledge Of Antibody-Derived Molecules
3/27/2024
Learn about monoclonal antibodies (mAbs) and current variants as well as how to set your purification strategy.
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Biopharma Resilience: Mass Immunization Programs
3/21/2024
Explore the challenges involved with mass immunization programs, what role government can play in facilitating vaccination programs, how technology is transforming the biopharma industry, and more.
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Process Development With “The End In Mind” For Startups
3/20/2024
We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.
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2024 LIMS Trends
3/15/2024
The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.
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Emerging Trends And Opportunities In Orally Inhaled Drug Products
3/8/2024
From targeting niche diseases to delivering cutting-edge medications, inhaled therapies are poised to become a cornerstone of modern medicine. Explore the intricacies of inhaled drug delivery.