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Case Study: Cmed’s Mobile Data Management Solution

The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers.

The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
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Pharmaceutical and Medical Industry Increasingly Demands Automated Testing Solutions

After the manufacturing processes in pharmaceutical and medical industries reached a high level of automation in recent years, manufacturers are more committed to automating their testing processes as well. Production-related tests as well as tests for product release are to be largely automated. In addition to higher specimen throughput, an increase in reproducibility through the elimination of operator influence is a main objective for manufacturers. Zwick Roell offers various levels of automation for testing syringes, insulin pens, and auto injectors.
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CPhI & P-MEC India 2018

12-14 December 2018, India Expo Mart, New Delhi, India

CPhI & P-MEC India (December 12-14, 2018) – organised by UBM (part of Informa PLC) – announces that the 12th edition of Asia’s largest Pharma exhibition is moving to the India Expo Mart, New Delhi. The new venue will see the exhibition now hosted in a single venue, bringing it closer to the Indian regulatory and legislative capital. New Delhi is also the country’s main international transport hub and will encourage an increased international attendance. In total, more than 50,000 people from 122 countries are expected, along with nearly 1,500 exhibitors.
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