|
Adeline Siew, PhD
Jean-Yves Balfin, product manager at Korsch AG, speaks to Pharmaceutical Technology Europe about the ins and outs of multilayer tableting.
/ read more /
| OUTSOURCING |
Susan Haigney
Industry experts discuss the challenges of performing glycan analysis and how companies can gain specific expertise from outsourcing partners.
/ read more /
| PEER-REVIEWED RESEARCH |
Haiyan Grady, Michael J. Kukulka, Takako Ono, Sai V. Nudurupati
This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.
/ read more /
| MANUFACTURING |
Chris O'Callaghan, Ian Jones, Piyush Patel, Edward Godek
A process control system based on PAT can compensate for variations in particle size, resulting in more consistent coating thickness.
/ read more /
Feliza Mirasol
Modular manufacturing systems offer a less costly way to increase capacity while reducing time-to-market.
/ read more /
| QUALITY |
Dennis Stephens, Helen Williams, Megan McMahon, Fenghe Qiu, Cherokee Hoaglund Hyzer, Elke Debie, Yan Wu, Hanlin Li, Jin Wang
A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
/ read more /
| SUPPLY CHAIN |
Agnes Shanley
Air transport continues to be the most secure way to ship valuable therapies, but it is also the riskiest. Standards are helping to improve service quality.
/ read more /
| EXTRACTABLES AND LEACHABLES |
Adeline Siew, PhD
Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.
/ read more /
| ASK THE EXPERT |
Susan J. Schniepp
The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.
/ read more /
|
|
