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Top Stories
A new framework featured in the Journal of Clinical Oncology will help physicians compare clinical trial results—and costs—of popular cancer medications.
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Kythera announces that it entered into a definitive agreement to be acquired by Allergan for $2.1 billion.
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Industry News
NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.
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Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.
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Supplier News
A new SGS Life Science Services laboratory outside Paris is designed for bio/pharmaceutical quality control testing.
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MFG Tray names ChemTech International as its first Master Pharmaceutical Distributor.
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Ion exchange resins have long been in the formulator's toolkit, but only recently has there been an increased interest in their use as excipients. Dow AMBERLITE™ and DUOLITE™ ion exchange resins have a broad range of applications, including taste masking, tablet disintegration, modified release, and the formulation of poorly soluble or unstable drug compounds.
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Bio/Pharma News
Kite announces that it will collaborate with bluebird bio to develop and commercialize second-generation T-cell receptor product candidates for HPV-associated cancers.
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The ruling will facilitate the market entry of generic versions of Copaxone, a widely prescribed drug to treat multiple sclerosis.
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Regulatory News
The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.
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The International Conference on Harmonization finalizes Q&A document on APIs.
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Successful Binding of Peroxide Sensitive APIs
Live Webinar: Tuesday, July 7th 2015 at 10 am EDT In this live webinar, Bernd and Jan will showcase how you can formulate your peroxide-sensitive drug using a binder that combines high binding strength with no peroxide formation at all.
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QUALITY
The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.
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REGULATORY BEAT
The pharmaceutical industry wants to speed up the variations process by eliminating redundant assessment by different national agencies in the European Union.
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MANUFACTURING
Stronger pipelines, the need for complex chemistries, and the rise of small- to mid-size innovators are driving demand for small-molecule APIs.
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TROUBLESHOOTING
Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.
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PEER–REVIEWED
This study examines the efficacy of a particle characterizing technology to capture particle images under dynamic conditions and to calculate particle size distribution data both in-line and at-line during fluid-bed granulation and milling.
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OUTSOURCING
Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.
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Solubility Enhancement Solutions Using Predictive Analytics & Molecular Modeling
On Demand Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
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Webcasts
On Demand
With increased inspection scrutiny on data integrity, it is critical that managers and scientists in GXP regulated laboratories understand the current regulatory position. Discover the criteria for data integrity and learn how to assess and improve laboratory data management processes to ensure compliance with current regulations.
Sponsored by: Mettler Toledo
On Demand Learn basics of water activity and the role it plays in the chemical stability, microbial content, and physical properties of pharmaceutical products. Hear experts discuss compendial and regulatory requirements for water-activity determination, and practical applications of water activity in marketed pharmaceuticals.
Sponsored by: Decagon Devices
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Practical Guidance for Successful Mammalian Cell Banking and Cell Line Characterization
On Demand Join us for this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
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on pharmtech tv
External Lubrication in Tablet Production
Trends and Concerns in Capsule Production
Focus on Biobetters, Part 2
Feeding Powders in Pharmaceutical Processes
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Events
July 16, 2015 | New Brunswick, NJ
July 22–25, 2015 | Barcelona, Spain
August 12–13, 2015 | Philadelphia, PA
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REFERENCE BOOKS
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Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations. / Learn more /
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eBOOKS
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This eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.
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