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Top Stories
A Federal circuit appeals court ruled that a biosimilar manufacturer must wait six months after FDA approval to commercially launch its medication.
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Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.
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A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting.
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GSK accelerates delivery timeline for US quadrivalent flu vaccine.
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PharmTech editors want to know about your information needs and preferences. Tell us in the annual reader survey.
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CPHI PHARMA AWARDS
The 2015 CPhI Pharma Awards honors innovation in all phases of small-molecule and large-molecule drug development.
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Just released – Tablet Press Replacement Parts and Accessories Catalogs
In addition to efficient, durable and highly-performing tablet compression tooling, Natoli Engineering Company also offers tablet press replacement parts for most makes and models of machines as well as tablet compression accessories to clean, maintain, analyze, and protect your tooling. Download a PDF of our new catalogs or request a quote online at natoli.com.
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Industry News
Industry experts from Biocon, PBOA, PCI, and Pharmatech Associates join CPhI annual report for 2015.
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AAPS Foundation announces 2015 new investigator grant and graduate student fellowship winners.
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Supplier News
Evans Analytical Group expands into the pharmaceutical/biopharmaceutical industry with acquisition of ABC Laboratories.
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AMRI expands its API portfolio and European presence through acquisition of Gadea’s Crystal Pharma Group.
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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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Bio/Pharma News
Sanofi’s new business-unit structure focuses on growth drivers.
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Mylan issued a voluntary withdrawal of calcium chloride intravenous infusion 10% w/v 10mL prefilled syringe due to difficulties in administration.
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Regulatory News
FDA releases a report that analyzes why some diseases are lacking treatment options.
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The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
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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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FORMULATION
Prodrugs and drug-delivery systems controlled by time, pH, and osmosis, are being used to prevent drug degradation in the stomach and large intestine and ensure drug release in the colon.
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PACKAGING AND LABELING
Electronic pharmaceutical tablet counters meet demands for accuracy, flexibility, speed, compact size, easy cleanability, and quick changeover.
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Webcasts
On Demand
This webinar, led by Milton Boyer, senior vice-president of drug product manufacturing at AMRI, will review and challenge the changing paradigms in the CMO/drug sponsor relationship. It is clear that both CMOs and drug sponsors are being held responsible for the actions of the other. Responsibilities once thought to be clearly defined are changing, with new guidance and expectations revealed in 483s and FDA warning letters.
Sponsored by: AMRI
On Demand
Ion exchange resins have long been in the formulator’s toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.
Sponsored by: Dow
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on pharmtech tv
Biologics Development and Manufacturing Trends Part 1
Biologics Development and Manufacturing Trends Part 2
Cell Therapies
Building Biopharmaceutical Manufacturing Processes
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Events
August 12–13, 2015 | Philadelphia, PA
August 18–20, 2015 | Philadelphia, PA
September 7–9, 2015 | Seoul, Korea
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REFERENCE BOOKS
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This three-volume set of comprehensive pharmacology reference guides cover solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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