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Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.
This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.
Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.
May 02, 2018
Choice of carrier can have a significant impact on the capsule filling process as well as the performance of the DPI formulation.
Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.
Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.
Public health authorities and the biomedical research community are seeking new strategies to address global health threats.
A skilled workforce is needed to deliver on technology’s promising medical advances.
Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.
The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.
April 30, 2018
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.