BROADENING THE DEFINITION OF TOLERABILITY IN CANCER CLINICAL TRIALS TO BETTER MEASURE THE PATIENT EXPERIENCE

November 7, 2018

Robust safety and tolerability data are essential in cancer therapeutic studies, and some trials are specifically designed with a key objective of demonstrating improved safety and tolerability. The development of a clinical trial framework and data elements to demonstrate comparative safety and tolerability requires a suite of endpoints and approaches to enable meaningful interpretation of results for regulatory and clinical decision-making.

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Nanomi

Over Nanomi: Nanomi ontwikkelt Nano en Microdeeltjes voor de farmaceutische industrie door middel van onze microfluidic Monosphere Technology. Wij zijn het “center of excellence for complex injectables” van Lupin ltd, een internationaal Indiaas farmaceutisch concern. Nanomi is een internationale, hightech omgeving met een leuke, informele werksfeer. Company Profile: Nanomi, based in Oldenzaal, is a drug delivery company developing pharmaceutical products based on nano- and microparticles. These particles are developed by using Nanomi’s microfluidic Monosphere Technology, enabling the manufacturing of very unique and uniform custom-made particles for a broad range of pharmaceutical products. In 2014 Nanomi was acquired by Lupin and became its center of excellence for complex injectables. Nanomi offers a highly innovative as well as dynamic environment and benefits from its parent company that was founded in 1968. Lupin is an innovation led transnational pharmaceutical company developing

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A Brief Synopsis of Modern Randomization Methodologies and Technologies

whitePaper | December 9, 2022

Randomized, double-blind clinical trials are the gold standard for adequate and well-controlled studies in modern times. However, prior to the late 1940s, randomization and blinding were not used in medicine and as result, bias was common.

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The Next Generation of Rare Disease Drug Policy

whitePaper | April 7, 2022

The United States defines a rare disease as a condition affecting fewer than 200,000 people in the country or one in which “there is no reasonable expectation” of recovering research and development costs.1 Examples of rare diseases include genetically-linked cancers, cystic fibrosis, and debilitating pediatric conditions like Gaucher disease and spinal muscular atrophy

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Paving the way for pharma R&D to use FAIR data

whitePaper | December 16, 2019

The use of FAIR (Findable, Accessible, Interoperable and Reusable) data in drug discovery and development could be transformational. But the pharma industry has been slow to embrace FAIR data — partially because of difficulties in establishing the necessary infrastructure and because of internal culture.

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Effects Of X-Ray Inspection On Pharmaceutical Products

whitePaper | December 12, 2019

X-ray inspection of pharmaceutical products and over-the-counter (OTC) medications are steadily increasing in use as pharmaceutical manufacturers worldwide strive to safeguard their brand reputations, protect consumers' welfare and comply with national and international regulations and legislation.

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Understanding the true cost of transparency reporting

whitePaper | December 14, 2022

When the regulatory hammer came down on pharmaceutical and life sciences (PLS) companies in the 2010s, it introduced new complexities for these businesses.

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Manual No More: Automating the Scientific Data Lifecycle

whitePaper | May 23, 2022

The world’s scientific data today is a morass. 50-80% of research scientist and data scientist time is spent wrestling with data before they can focus on highervalue AI/ML and advanced analysis to help bring new life-saving therapeutics to market.

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Spotlight

Nanomi

Over Nanomi: Nanomi ontwikkelt Nano en Microdeeltjes voor de farmaceutische industrie door middel van onze microfluidic Monosphere Technology. Wij zijn het “center of excellence for complex injectables” van Lupin ltd, een internationaal Indiaas farmaceutisch concern. Nanomi is een internationale, hightech omgeving met een leuke, informele werksfeer. Company Profile: Nanomi, based in Oldenzaal, is a drug delivery company developing pharmaceutical products based on nano- and microparticles. These particles are developed by using Nanomi’s microfluidic Monosphere Technology, enabling the manufacturing of very unique and uniform custom-made particles for a broad range of pharmaceutical products. In 2014 Nanomi was acquired by Lupin and became its center of excellence for complex injectables. Nanomi offers a highly innovative as well as dynamic environment and benefits from its parent company that was founded in 1968. Lupin is an innovation led transnational pharmaceutical company developing

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