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Monthly Archives: November 2014

Uncertain, unknown or essentially unknowable?

‘Understanding what is uncertain, what is unknown or what is essentially unknowable, and what to do about it in a reimbursement submission’ – this was the key topic for discussion of the Australian Chapter of the International Society for Pharmacoeconomics … Continue reading

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Alternatives to Bioequivalence Trials

Earlier this week, Dr Greg Pearce, one of our senior regulatory consultants, presented at the ARCS Melbourne education seminar. His topic was the science and practical application of in vitro alternatives to conventional bioavailability and bioequivalence (BABE) clinical trials in … Continue reading

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Local pharma expertise and know how: why you need it

Entering a new marketplace – whether for a medicine, a cosmetic, a device or a complementary medicine – is challenging, time consuming, expensive and often just difficult. There are stringent regulations to be met, local insights to be grasped, specific … Continue reading

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What treatment switching means to the future of clinical trials

More and more frequently, treatment switching is occurring in clinical trials, particularly in the area of oncology. Not surprisingly, patients are demanding to be switched (most commonly) from the control treatment arm of a trial to the experimental treatment or … Continue reading

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Avoid Safety Data Exchange Agreements headaches

Safety Data Exchange Agreements (SDEAs) are an integral part of the collaboration we see in the pharmaceutical industry these days. Where multiple companies work together to develop and market drugs and devices, large amounts of information are collected by a sometimes … Continue reading

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