The War between Scientific Specialists and Quality Assurance

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BY: KARIN LILTORP

Karin Liltorp

Have you ever been involved in a war between scientific specialists and quality assurance (QA)? Specialists say “this requirement does not make sense!” And QA says “the guideline states….” If they do not agree, QA usually has the last word, as they have to give the final approval. Continue reading

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

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