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April 02, 2020
Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.
Pharmaceutical Technology spoke with Jens Andersson, purchasing director at Cambrex Karlskoga, about the best way to ensure the security of the bio/pharmaceutical materials supply chain.
April 01, 2020
With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.
March 15, 2020
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
March 02, 2020
No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.
Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.
A brief overview of three notable cases of adverse drug reactions.
EU regulators have accelerated their efforts to use the mass of data emerging from the lifecycles of drugs as an effective basis for both the development and control of medicines.
Outsourcing stability testing to full-service providers can offer comprehensive benefits to bio/pharma companies.