Top Stories
The NIH has launched a Phase I clinical trial in humans of an investigational Zika vaccine.
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FDA approved Natco and Alvogen's generic Tamiflu to treat and prevent influenza.
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Industry News
A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.
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Sanofi Pasteur will deliver the first of more than 65 million influenza vaccines to the United States throughout the 2016–2017 flu season.
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EXPERT INTERVIEW
Richard Denk, head sales containment at SKAN, spoke with Pharmaceutical Technology about trends in handling high potency APIs.
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Supplier News
The company will install new vial-filling and lyophilization capacity, including an isolator-based filling machine. The new filling equipment will result in a five-fold increase in the company's current filling capacity.
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MilliporeSigma will provide support to Y-mAbs for the development of its monoclonal antibody for the treatment of pediatric brain cancer.
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Revitalize your pesticide quantitation workflows
Compelling productivity and efficiency enhancements are available for laboratories performing targeted pesticide quantitation. The Thermo Scientific™ Pesticide Explorer Collection is a comprehensive set of LC-MS solutions with tested methods, designed for laboratories performing routine quantitation, targeted and non-targeted screening of pesticide residues in food matrices.
Choose one of four solutions to implement triple quadrupole or high-resolution accurate-mass Orbitrap™ MS methods.
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Bio/Pharma News
The collaboration will focus on methods to eradicate cancer stem cells.
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Opdivo did not meet primary endpoints in Phase III trials investigating the drug as a monotherapy for untreated advanced non-small cell lung cancer in patients whose tumors expressed PD-L1.
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Natoli Engineering Company maintains a large selection of replacement parts for nearly every tablet press on the market—ready for immediate worldwide delivery. By stocking more than 250,000 replacement parts on our premises, we're able to save our customers up to 50% of the cost of Original Equipment Manufacturers. Check out our extensive parts and accessories catalog online at
 Natoli.com |
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Regulatory News
The report addressed how the agency might support medicine development for patients' unmet medical needs.
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The cyclin dependent kinase inhibitor received Breakthrough Therapy Designation as a first line treatment for advanced breast cancer.
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How to Define and Build a Risk Management Strategy for Quality and Compliance Management Systems
With increasing oversight on compliance regulations and standards, complexity becomes a growing theme, whether in Quality Management or general compliance.
In this white paper learn about how compliance is necessary, and it can be a significant investment on an organization.
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MANUFACTURING
PharmTech's 2016 survey shows general satisfaction with existing solid-dose and parenteral manufacturing equipment, and slow adoption of continuous manufacturing processes.
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EQUIPMENT
New technology introduced in 2016 aids innovation growth for pharmaceutical manufacturing.
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IVT's 22nd Annual Validation Week provides the most up-to-date and comprehensive information on new global regulations, technology advances and industry case models for developing, implementing and deploying validation procedures enterprise-wide. This year's conference features brand new perspectives, a can't-miss FDA Keynote Address, compelling insights into regulatory warnings and trends and validation tools, techniques and strategies that directly apply to your actual work situations.
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PEER-REVIEWED RESEARCH
This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
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New Trends in Hygienic Diaphragm Valves that Improve Reliability
LIVE WEBCAST: Thursday, September 22, 2016 at 11:00 am EDT
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Webcasts
On Demand
In this educational webcast, learn about regulatory expectations and practical approaches to stability testing of drug substances and drug products for clinical trials, packaging, storage, and transportation.
Sponsored by SGS Life Science Services |
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Sustained-Release Formulation: Overcoming Key Challenges Like Alcohol-Induced Dose Dumping
LIVE WEBCAST: Tuesday, September 13, 2016 | 11 am EDT | 10 am CDT | 8 am PDT
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On Demand
When lab workloads seem too high to handle, analysis results or approvals are late, or lead times are exceeded, it is time to take a closer look at a lean lab approach, especially before investing in new resources such as equipment, premises, or personnel.
Sponsored by Mettler Toledo
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Understanding the Relationship between Critical Quality Attributes and the Microstructure of Topical Semi-Solid Formulations
LIVE WEBCAST:Thursday, September 8, 2016 at 11 am EDT | 10 am CDT | 8 am PDT
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Events
August 17-18, 2016
September 12-14, 2016
September 18-21, 2016
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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.
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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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