Can Clinically Relevant Dissolution Specifications Be Developed for All Drug Products?


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By Kenneth Norris

APQ1What progress has been made on establishing clinically relevant specification implementation, and what are the opportunities to align on the application of scientific approaches? Asking end product testing to adequately serve as a quality control and as a clinically relevant surrogate has always been a challenge. Because the dissolution test has been identified as a potential basis for granting biowaivers, it is a logical test to establish clinically relevant acceptance criteria. Continue reading

Pediatric Medicines Are Not Child’s Play!


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By: Jennifer Walsh

Jennifer WalshSince the introduction of pediatric regulations in the USA (Pediatric Research Equity Act and Best Pharmaceuticals for Children Act) and Europe, there has been a huge  increase in the number of medicines that have information about their use for children. However, despite the expansion of research in the development of pediatric medicinal products, there is still an unmet need for off-patent medicines for children. Incentives in the form of funding support and data protection have not markedly increased the number of off-patent pediatric product licences.  Continue reading

What’s the Big Deal? Pharma Mergers and Acquisition Take Off


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By: Charchil Vejani

Charchil VejaniThe pharmaceutical industry seems besieged on all sides, with declining research and development (R&D) productivity, expiring patents on blockbuster products, and relentless downward pricing pressure forcing companies to look closely at the bottom line. One effect of this onslaught has been an upsurge in the levels of merger and acquisition (M&A) activities as players within the industry consolidate to cut costs, expand research pipelines, and lengthen geographic reach. Many pharmaceutical industry mergers and acquisitions have occurred in the past year. Deals in the pharmaceutical industry has increased in 2015 and it is worth $300 million. Before 2015, Western European and the Canadian market were attractive for such deals, but in 2015, this trend began to move toward the U.S. market and emerging markets such as India and China. Continue reading

Can’t You Feel My Pain? Those Left Behind in the Purple Rain


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By: Robert G. Bell

Robert G. BellI remember the summer of 1984, watching “the kid” on the silver screen sear a riff with that Cloud guitar as he stepped to the mic and sang “I never meant 2 cause u any sorrow, I never meant 2 cause u any pain.” But the kid did cause us a whole lot of sorrow and a whole lot of pain. Now the kid is gone and can never explain, why we won’t ever hear you laughing or singing purple rain.

On April 21, 2016, one of the most talented musicians this world has ever seen, Prince Rogers Nelson, died of fentanyl overdose. The many years of touring and dancing in high-heeled boots left the musician with chronic hip pain that was managed with potent narcotic opioids such as fentanyl. Perhaps due to the chronic hip pain, Prince’s last tour was the Piano and Mic tour where his stage movements were a bit more subdued when compared to his previous tours, but the shows were powerful as well as unique as the music this man created. Continue reading

Smartphones for Research


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BY: Prathap Shastri

Quick Perspective GraphicQuick Perspective on Google’s new app lets users conduct scientific research on their phones

This is avaliant effort by Google to introduce an Android app to facilitate experiments based on sound and light measurement. With such advancements in technology, I will not be surprised if there will be a day when we can start to use apps on our smartphones and tablets to collect and integrate data from HPLC and mass specs, and also possibly perform electrocardiographic monitoring using smartphones in the hospitals! Smartphone-compatible medical devices are already making into market and there has been an increased amount of research on bringing smartphones to clinic. It will be great to see technology blend with researchers’ needs and facilitate experiments in the labs as well!

Do you have any creative ideas on how you would like to use your smartphones in your day-to-day research?

PRATHAP SHASTRI works for the ADME/DMPK group at Charles River Laboratories in Ashland, Ohio. Prior to joining Charles river laboratories, he worked at Seventh Wave Laboratories working as a principal investigator for the PDM group.

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