Regulatory/QbD
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Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimpl…
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Getting it Right from the Start in the Drug Development Process
Proper process understanding allows researchers to critically identify factors that impact the drug substance and product as well as minimize or maint…
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Principles & Methodology Handbooks
Find practical tips and in-depth information about common methodologies used in the lab.