| LIPID-BASED FORMULATION |
Adeline Siew, PhD
Lipid-based formulations offer a means of addressing the physicochemical and biological challenges of poorly soluble APIs.
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| PEER-REVIEWED RESEARCH |
Stan Altan, Yilje Dong, Mary Ann Gorko, Niels Vaever Hartvig, Mark Johnson, Gregory Larner, Stacy Sherling
Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
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| SOLID-DOSAGE MANUFACTURING |
Jennifer Markarian
A twin-screw extruder can be used as a continuous wet granulator.
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| IMPROVING FREEZE DRYING |
Jeff Kenvin
Non-destructive surface area measurement can improve stability testing.
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| ANALYTICS |
Amber Lowry
Experts discuss analytical procedures for the lot release testing of small-molecule pharmaceuticals.
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| PACKAGING |
Hallie Forcinio
Barrier materials, scavengers, and good seal integrity maximize shelf life of oral solid-dosage drug packaging.
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| SUPPLY CHAIN SECURITY |
Agnes Shanley
Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.
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| OUTSOURCING DEVELOPMENT |
Susan Haigney
Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.
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| US REGULATORY WATCH |
Jill Wechsler
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
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| GUEST EDITORIAL |
Binodh DeSilva
Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.
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| STATISTICAL SOLUTIONS |
Christopher Burgess
This article applies the basics of stability, performance, and capability to modern process performance and capability indices.
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| ASK THE EXPERT |
Susan J. Schniepp
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
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