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March 4, 2025: PRIM-ER Team Develops Innovative Statistical Techniques for Stepped-Wedge Trials

Rethinking Clinical Trials

Stepped-wedge designs can be advantageous when simultaneous rollout of the intervention to all clusters is infeasible, or when withholding the intervention from any cluster would be unethical, or when there is a risk of contamination between intervention subjects and control subjects. Learn more about PRIM-ER.

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Making sub-visible particles visible

Bio Pharma Dive

Sub-visible particles can lower the effectiveness of a drug, which is why regulatory authorities are demanding processes be developed, validated and set up in such a way as to minimize all forms of contamination.

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MIT Scientists Develop Food Sensor That Can Detect Spoiled or Contaminated Food

XTalks

MIT engineers have designed a food sensor , made from an array of silk microneedles, that can pierce through the plastic packaging of foods to sample for bacterial contamination and spoilage. Two kinds of specialized “bioinks” react to the bacterial presence and certain pH levels, which respectively detect contamination and spoilage.

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The right viral safety program can guard against costly bioburden incidents in biopharma development

Bio Pharma Dive

Viral contamination threatens biopharmaceutical development, making viral clearance and safety essential for risk mitigation.

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Some food contamination starts in the soil

Scienmag

Credit: Matt Limmer When most people hear “food contamination,” they think of bacteria present on unwashed fruits or vegetables, or undercooked meat. However, there are other ways for harmful contaminants to be present in food products.

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In the News: July 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. This prospectively developed comparative evidence was used to great advantage by Astellas as RWE in its submission for this new approval.

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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. In contrast, most biologics are complex mixtures that are difficult to completely identify or characterize.