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| home > white papers > R&D to Product: How to Reduce Costly Scale-Up Problems - Natoli Engineering Company, Inc. |
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 WHITE PAPERS |
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Natoli Engineering Company, Inc.
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R&D to Product: How to Reduce Costly Scale-Up Problems
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When scaling a new drug formulation from the development side of R&D into manufacturing, there is often a reality check with respect to process scaleup and performance of the formulation at production levels. Problems with capping/lamination and sticking/ picking are often first realized when a formulation is introduced to a level of compression required to supply market demand.
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News and Press Releases |
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The global pharmaceutical solutions company on a mission to help manufacturers keep their supply chains moving
The current crisis in Europe has led to increasing energy insecurity and shortages of raw materials, which are creating severe pharmaceutical manufacturing supply line disruptions. In some cases, supplier lead times have doubled, prices are no longer certain, and orders are subject to cancellations or delays.
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White Papers |
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Case Study: Cmed’s Mobile Data Management Solution
Cmed Clinical Services
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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