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Recently Posted Blogs
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- Analytical Discussion
AstraZeneca today announced a collaboration with the Montreal Heart Institute (MHI) in Quebec, Canada, to search the genomes of up to 80,000 patients for genes associated with cardiovascular diseases and diabetes, their complications and treatment outcomes. This is one of the largest such screens of its type to date and will drive understanding of the biological mechanisms underlying these conditions […]
F2 parameter is widely used parameter in drug dissolution testings where it is often used to predict similarity of two dissolution profiles. F2 factor In short, two profiles are considered identical when f2=100. An average difference of 10% at all measured time points results in a f2 value of 50. A public standard of f2 value between 50-100 to indicate similarity […]
The FDA cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation. This expanded use allows healthcare providers to use one or two negative Xpert MTB/RIF Assay test results to help them determine whether a patient showing signs and symptoms of pulmonary TB should continue to be […]
Pharmaceutical Technology‘s 2015 Solid Dosage and Excipients 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. Issue topics include: Advances in Tableting Analytical Techniques for Efficient OSD Formulation Improving Pharmaceutical Palatability Improving Efficiency in Hot Melt Extrusion and Spray […]
The new ICH Q3D Guideline for Elemental Impurities has initiated reviews and changes in quality testing programs in bio/pharmaceutical companies around the world. Companies need to assess the risks of potential elemental impurities in their process and materials streams. In this webcast, experts review the requirements of elemental impurities guidelines, practical recommendations to address implementation challenges, and key considerations for […]
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment. Register free: www.pharmtech.com/pt/stabilitySponsored by Patheon
This webcast invites all pharmaceutical scientists and formulators from R&D and analytical departments that have an interest in the solubilization of poorly soluble drugs, and in understanding the importance of choosing a proper dissolution method in the solubilization tests to reveal the full potential of the tested solubilization method. Register free www.pharmtech.com/dissolutionSponsored by BASF
Strategies and case studies on Systematic and Efficient Analytical Method Development for A Speedy Clinical Product Development presented by experts at Patheon. Learn how to accelerate your first-in-man studies with a deliberate approach to analytical method development for early stage drug products. Register free www.pharmtech.com/efficientSponsored by Patheon
Recently Posted Blogs
- All
- Analytical Discussion
AstraZeneca today announced a collaboration with the Montreal Heart Institute (MHI) in Quebec, Canada, to search the genomes of up to 80,000 patients for genes associated with cardiovascular diseases and diabetes, their complications and treatment outcomes. This is one of the largest such screens of its type to date and will drive understanding of the biological mechanisms underlying these conditions […]
F2 parameter is widely used parameter in drug dissolution testings where it is often used to predict similarity of two dissolution profiles. F2 factor In short, two profiles are considered identical when f2=100. An average difference of 10% at all measured time points results in a f2 value of 50. A public standard of f2 value between 50-100 to indicate similarity […]
The FDA cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation. This expanded use allows healthcare providers to use one or two negative Xpert MTB/RIF Assay test results to help them determine whether a patient showing signs and symptoms of pulmonary TB should continue to be […]
Pharmaceutical Technology‘s 2015 Solid Dosage and Excipients 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. Issue topics include: Advances in Tableting Analytical Techniques for Efficient OSD Formulation Improving Pharmaceutical Palatability Improving Efficiency in Hot Melt Extrusion and Spray […]
Member Activity
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Pharma Live wrote a new post
Channel strategy and orphan drugsA channel strategy is a plan for guiding decisions about a product’s distribution channel, ie the chain of intermediaries that it passes from its production through to delivery to the end user. While channel strategy...
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Pharma Live wrote a new post
What is the difference between patents and exclusivity? Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug...
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Pharma Live wrote a new post
What XML resources are available at the USPTO to process bulk data? Bulk data uses different versions of XML depending on the year of data publication. Links to older versions of the documentation may be found at http://www.uspto.gov/learning-and-resources/xml-resources/xml-resources-retrospective. The USPTO generally does...
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Pharma Live wrote a new post
How long does a granted patent stay valid? The maximum term of a European patent is 20 years from its filing date. The patent may lapse earlier if the annual renewal fees are not paid or if the patent is...
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Pharma Live wrote a new post
Gilead Sciences ($GILD) has been able to withstand scathing criticism at home over the prices of its hep C cures, negotiate with stingy price watchdogs abroad and face down criticism in developing countries by giving generics producers access to...
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Pharma Live wrote a new post
Wm. Bolthouse Farms, Inc., Bakersfield, CA, inventive container permits point-of-use mixing of separate, compartmentalized ingredients without rupturing the main container seal. The food package can be a cup and can include an exterior sealing enclosure, an interior barrier, the...
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Pharma Live wrote a new post
Wyeth, which was acquired by US- based pharma major Pfizer Inc, has suffered a major setback in India with the country’s patent office rejecting the company’s application for an injectable form of its renal cell cancer drug, Temsirolimus, marketed...
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Pharma Live wrote a new post
OF ALL the goods and services traded in the market economy, pharmaceuticals are perhaps the most contentious. Though produced by private companies, they constitute a public good, both because they can prevent epidemics and because healthy people function better...
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Pharma Live wrote a new post
The debate over the Trans-Pacific Partnership (TPP) has taken center stage in policy circles in recent weeks. Its proponents promise a major economic bonanza from expanded trade. It’s not clear that the economics supports this claim. The United States Department...
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Pharma Live wrote a new post
On February 6, 2015, the Food and Drug Administration (FDA) published in the Federal Register (FR) a comprehensive proposed rule (80 FR 6802) to amend agency regulations governing Abbreviated New Drug Applications (ANDAs) and 505(b)(2) New Drug Applications (505(b)(2)...
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Otsuka Pharmaceuticals Company Limited’s application, 4 March 2015, Dr Lawrence Cullen, for the United Kingdom’s Intellectual Property Office (UKIPO), held that it was not possible to grant an application for a paediatric extension for patent protection when the conditions for...
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Pharma Live wrote a new post
The Court of Justice of the European Union (CJEU) delivered its ruling in Case C‑577/13, Actavis Group PTC EHF, Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG, this being a request for a preliminary ruling from the Patents...
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Pharma Live wrote a new post
The Japanese Patent Act was revised on May 14, 2014 to provide for post-grant oppositions within one year of the rule change, i.e., by May 14, 2015 (the exact effective date has not yet been set). Under the new opposition system,...
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Pharma Live wrote a new post
The U.S. Patent and Trademark Office (USPTO) recently launched the Patent Application Alert Service (PAAS), a free electronic tool aimed to keep the public apprised of the publication of patent applications. Through the tool, a user can create customized email alerts...
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Pharma Live wrote a new post
U.S. patent applicants often have an interest in expediting the patent examination process. The desire to speed examination can result from issues related to the availability of an inventor, possible infringing activity by a third party, business conditions or...
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Pharma Live wrote a new post
On January 9, 2015, the Federal Register published final rules implementing changes to patent term adjustment (PTA) in view of Novartis v. Lee, which the Federal Circuit decided last January. The new rules affect patents where a request for continued examination (RCE)...
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Pharma Live wrote a new post
the United States District Court for the Southern District of Indiana joined the District of Delaware and Eastern District of Texas as the first courts to consider a generic drug manufacturer’s motion to dismiss a Hatch-Waxman patent infringement action...
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Pharma Live wrote a new post
COPENHAGEN, May 20 (Reuters) – Novo Nordisk said on Wednesday it rejected claims by U.S. rival Baxter International that it had infringed patents on drugs to treat the bleeding disorder haemophilia, the Danish company said on Wednesday. Baxter had said...
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Pharma Live wrote a new post
Pfizer Inc. (NYSE:PFE) is trying to overcome the patent cliff that has seen its recent quarter results suffer by adopting its classic strategy of forging marketing alliances and making acquisitions. The pharma giant recently agreed to buy a stake in...
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Pharma Live wrote a new post
As our television screens toggle between pundits squabbling over Obamacare’s insurance rules and ads for erectile dysfunction remedies, another health care battle rages in village clinics and corporate boardrooms. Behind the seductive commercials for breakthrough treatments, multinational brands and...
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