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March 01, 2012
This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment.
Taste-masking is an important consideration to ensure patient compliance.
FDA answers key questions about the October 2011 guidance on using physical–chemical identifiers in solid oral dosage products to help prevent and avoid counterfeiting.
February 02, 2012
As biopharmaceutical development and commercialization increases, companies are expanding their cold-chain capabilities.
A new class of nanoparticles hold promise for preventing premature drug release and offering greater accuracy and effectiveness in drug delivery.
February 01, 2012
A technical forum featuring Catalent Pharma Solutions, SAFC, and Neuland Laboratories.
January 02, 2012
The authors designed an upper punch with a removable punch tip to determine a tablet formulation's propensity to stick by weighing the mass of powder adhered to the punch tip.
Challenges remain, particularly for early-stage biopharmaceutical companies.
Some recent advances involve strategies for accelerating reaction discovery, approaches for inducing chirality and stereochemical analysis, and applications in nanotechnology for protein elucidation.
Creating a successful antibody-drug conjugate requires careful selection of the drug, antibody, and linker.