November 2016
Volume 40, No. 11 |
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| FOCUS |
Agnes Shanley
Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.
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Agnes Shanley
Recent astronomical price increases have driven accusations that some pharma companies are price-gouging.
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| METHOD DEVELOPMENT |
Wendy Saffell-Clemmer, Jacquelyn Karty
The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.
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PharmTech November Issue
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| CONTINUOUS MANUFACTURING |
Paul Lopolito, Elizabeth Rivera
A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.
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Sarang Oka, Sara Moghtadernejad, Zhanjie Liu, Douglas Hausner, Fernando Muzzio
Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.
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| DISSOLUTION TESTING |
Adeline Siew, PhD
A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.
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| PEER-REVIEWED RESEARCH |
David W. Osborne
This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.
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| FORMULATION |
Carrie Cao, PhD
A variety of strategies have been employed to deliver proteins and peptides in improved parenteral formulations and/or via noninvasive routes.
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| API SYNTHESIS & MANUFACTURING |
Cynthia A. Challener
FDA redefines cocrystals as APIs and not drug-product intermediates.
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| SUPPLY CHAIN |
Agnes Shanley
Vendor selection and materials testing are complex enough, but in today's volatile environment, risk mapping and monitoring are also crucial.
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| REGULATORY WATCH |
Jill Wechsler
Reliable, high-quality products require innovative analytics and production.
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| OUTSOURCING |
Jim Miller
CMO executives are focusing on M&A activity, new business models, and fundraising limits.
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| ASK THE EXPERT |
Siegfried Schmitt
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
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| FROM THE EDITOR |
Rita C. Peters
CPhI Pharma Award winners were recognized for sweating the details for the bigger picture.
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| PRODUCT SPOTLIGHT |
Sartorius Stedim Biotech's polyethersulfone membrane is now integrated into two new, sterile Sartocon benchtop and production-scale filtration assemblies.
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Dual-Shaft Mixers from Ross, Charles & Son are suitable for mixing 50-, 100-, and 200-gallon batches.
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Yarra 1.8µm SEC-X300 from Phenomenex is a high-resolution gel filtration chromatography (GFC)/aqueous size-exclusion chromatography (SEC) column for the separation of high molecular weight biomolecules on high-performance liquid chromatography and ultra-high pressure liquid chromatography systems.
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The InvivO2 workstations range from Baker Ruskinn allow researchers to conduct cell culture processes under a continuously controlled, physiologically relevant atmosphere.
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| Events |
November 13–17, 2016
November 16, 2016
March 8–10, 2017
more events
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