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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2004. About the author.

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Root Causes of Depression and Hashimoto’s

The Thyroid Pharmacist

A study in 2004 found an association between the presence of a mood disorder, and the presence of thyroid peroxidase (TPO) antibodies. (5) Around 60 percent of readers whom I surveyed, reported an improved mood after switching to a T3/T4 combo medication like Nature-Throid, WP Thyroid, Armour, or a compounded T4/T3 version.

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Accommodating Multiple Modalities in the Same Facility

ISPE

EU human tissues and cells directive 2004/23/EC; 7. Manufacturing of (or with) high-potent compounds in adjacent suites may be possible with the appropriate engineering controls and risk assessments based on toxicity data. Published March 2004. Published October 2004. FDA CFR Title 21 Parts 211, 600, and 1271; 8. ,

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. September 2004. Nature Communications 12, no. September 2004. Journal of Pharmaceutical Sciences 111, no. 3 (2022):593–607.

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How Thyroid Disease Affects Men

The Thyroid Pharmacist

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. In fact, in 2006, the Centers for Disease Control reported that the average American has 116 out of the 148 commonly tested synthetic compounds in their body. BMC Psychiatry.

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CMC Requirements for New Drug Registration in Latin America

ISPE

Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing. “By April 2004. 012166 from 2004. Published 8 March 2022.

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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. The use of structured content and data management in CMC regulatory submissions could potentially provide a direct link to proactively manage risks in the supply chain and communicate with regulators.