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Top Stories
Value assessment initiatives are expected to have a major impact on drug use and reimbursement.
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Mylan reached a $485-million settlement with the Department of Justice over questioned raised about the Medicaid rebate classification of EpiPen.
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Subscribers can enjoy each full issue of Pharm Tech in print, or via Pharm Tech apps.
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Industry News
A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.
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HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.
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EXPERT INTERVIEW
Rajesh M. Dave, distinguished professor at the New Jersey Institute of Technology, sat down with Pharmaceutical Technology to discuss polymer thin films for drug delivery.
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The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
In a market where high-demand causes organizations to seek software systems that will fit into their complex business infrastructure, the pressure to find the right system often causes angst to many.
Learn some key elements to spotting a good FDA Compliance solution and techniques for achieving GMP Compliance.
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Supplier News
The company revealed its new Always Solving corporate identity following its eventual separation from Valvoline.
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Constantia Flexibles acquired a flexible packaging business from Lamp San Prospero SPA.
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Bio/Pharma News
The companies entered into a collaboration and license agreement for Crescendo's Humabody-based therapeutics.
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The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.
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Time is running out to join Natoli Engineering for their last Basics of Tablet Manufacturing and Troubleshooting training course, November 1 – 3. Training sessions include lectures and hands-on experiences in tablet design, tablet press setup and operation, tool rework and polishing, and more! If you are a tooling technician, tablet press operator, tablet press maintenance technician, or QC/QA personnel, this training is for you!
 Sign up NOW! |
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Regulatory News
The agency's Patient-Focused Drug Development program completed its commitment ahead of schedule.
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IVT's Analytical Procedures and Methods Validation is dedicated to developing and implementing processes that survive the lifecycle. Join your colleagues to understand regulatory trends (FDA, MHRA, USP and beyond), implement an effective method transfer strategy, perform an analytical methods comparability study, implement a QbD approach and more! With the influx of regulations affecting the analytical laboratory landscape, the need for compliance is crucial.
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FORMULATION
Excipients play a crucial role in the manufacturing of solid-dosage forms and the performance of the finished drug product.
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PEER-REVIEWED RESEARCH
This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.
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PACKAGING
The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
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SUPPLY CHAIN
As criminals duplicate the latest overt security technologies, pharmaceutical manufacturers are evaluating covert and layered approaches to fight counterfeiting, theft, and illegal product diversion.
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AAPS Exhibitor Guide
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Halo Pharma is a full-service contract manufacturing and development organization that partners with large pharmaceutical, biotech, and generic pharmaceutical companies.
AAPS Booth # 451
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Our Korsch XL 400 single- and multi-layer tablet technology ensures the highest regulatory standards quickly, flexibly, and reliably.
AAPS Booth # 1835
/ Learn more / |
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Leistritz' LHLG series air quench pelletizer mates with an extruder and enables die face cutting of pellets in air for water soluble, highly filled and foamed formulations as typically used for pharmaceutical products.
AAPS Booth # 1270
/ Learn more / |
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Natoli's tooling storage boxes are intended for storing, transportation, and cleaning of tooling while being safely secured in a single container.
AAPS Booth # 1353
/ Learn more / |
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For inhalation and nasal drug product development, Catalent's formulation expertise and experience have been successfully applied to multiple dosage forms.
AAPS Booth # 901
/ Learn more / |
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UPCOMING WEBCASTS
Biocompatibility Testing of Combination Devices – New Regulatory Guidance
Live Webinar: Thursday, November 3 at 8:00 am PDT
 Register now
Reversed Phase Liquid Chromatography using Surrogate/Additional Stationary Phases
Live Webinar: Wednesday, October 26 at 11am EDT
 Register now
A Wireless Approach to Monitoring Systems in Complex, Regulated Environments
Live Webinar: Tuesday, October 25 at 2:00pm EDT
 Register now
Strategies for IND Filing Success
Live Webinar: Friday, October 21 at 11:00am EDT
 Register now
Implementing On-Dose Anticounterfeiting Technologies for Solid-Dose Drug Products
Live Webinar: Friday, October 14, 11:00 AM EDT
 Register now
Don't Let Your Diluent be the Weakest Link in Your Drug Product
Live Webinar
Asia/Pacific Session: Thursday, October 13, 2016 at 3:00pm SGT (Singapore)/ 4:00pm JST (Tokyo/Korea)
US/EU Session: Thursday, October 13, 2016 at 10:00am EDT (New York City)/ 3:00pm BST (London)/ 4:00pm CEST (Berlin)
 Register now
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Events
November 7–8, 2016
November 13–17, 2016
November 16, 2016
more events |
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REFERENCE BOOKS |
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A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
/ Click here /
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eBOOKS
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Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems. |
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