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Three strategies for managing loss of exclusivity successfully

pharmaphorum

Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. 6 The stakes were extremely high, with annual costs of insulin reaching $736 per patient in 2013, up threefold since 2002. RESULT: As of 2002, 40% of PRILOSEC patients had switched to NEXIUM, which notched up sales of $3.9

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

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Are Your Adrenals Sabotaging Your Health?

The Thyroid Pharmacist

In most cases of adrenal fatigue, the problems generally originate in a communication breakdown that occurs within the hypothalamic-pituitary-adrenal axis, otherwise known as the HPA axis. [2] The effects of chronic stress on health: new insights into the molecular mechanisms of brain-body communication. doi:10.1055/s-2002-34587. [21]

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Published 2002. You may unsubscribe from these ISPE communications at any time. Burke, PhD. 1 September 2022.