The authors present an update to the Wyeth/BASF experience with the IPEC Novel Excipient Safety Evaluation Procedure.
Tocophersolan or TPGS was developed 60 years ago as a water-soluble form of vitamin E. The author gives an overview of TPGS, including its interesting properties, examples found in the literature, and a brief summary of the regulatory status and marketed formulations.
Training cleanroom operators can be one of the most challenging aspects to maintaining cleanroom conditions. PTE speaks to Neal Wesley, technical director at SCM Pharma, to find out the best practices for training and ensuring continued compliance.
The authors discuss a novel particle engineering technology based on mechano-chemical activation.
Formulating an injectable solution containing both hydrophilic and hydrophobic drugs is a challenge.
Formulating an injectable solution containing both hydrophilic and hydrophobic drugs is a challenge.
Formulating an injectable solution containing both hydrophilic and hydrophobic drugs is a challenge.
Formulating an injectable solution containing both hydrophilic and hydrophobic drugs is a challenge.
A revision and modernization of the IPEC Significant Change Guide incorporates concepts of risk assessment.
Market changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain.
Market changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain.
Novartis announces that its lung cancer drug, Zykadia, gained European Union approval.
Small- to medium-sized companies are expected to drive near-term growth of the global biomanufacturing outsourcing market.
This paper answers a major concern of manufacturers: Do x-rays affect the quality and efficacy of a drug during product inspection?
USP is developing new guidelines to help organizations prioritize risk and ensure raw material quality.
A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.