ISPE

MARCH 8, 2023

This article proposes recommendations for industry and RAs to address the identified problems. 23 Packaging-Related Contaminants Eighteen studies reported contaminants from drug packaging. 28 , 29 , 30 , 31 One key cause was attributed to the incompatibility between the packaging materials and the product.

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The Thyroid Pharmacist

AUGUST 19, 2022

In this article, I’ll dive a little bit deeper into: How infections can act as Hashimoto’s triggers. 2-5) I’ll share more about this later in this article, but for now, I wanted to mention that this is why I look at hundreds of studies and patient cases before I dismiss a trigger after just one study. pylori affects Hashimoto’s.

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ISPE

SEPTEMBER 11, 2023

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities.

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The Thyroid Pharmacist

OCTOBER 27, 2023

3] You can learn more about the HPA axis and adrenals here in the linked article. Follow package instructions. Follow package directions for each supplement. If you’re experiencing these symptoms, reduce your dosage to ⅛ teaspoon daily, increasing usage slowly, as tolerated, to get to the recommended label usage.

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The Thyroid Pharmacist

MARCH 3, 2023

In this article, I’d like to dive a little deeper into the many benefits of magnesium for those with Hashimoto’s, including: How the body uses magnesium The magnesium and thyroid connection Causes and symptoms of magnesium deficiency Conventional and natural treatment options How Does Magnesium Work in the Body? 2014;12(3):44-64. 2014.11.002.

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ISPE

MAY 9, 2023

This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America. In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from.

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ISPE

MARCH 29, 2023

This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements.

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ISPE

MARCH 29, 2023

This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

JULY 6, 2023

This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach to risk management can help CM achieve its full potential. Deep Learning for Continuous Manufacturing of Pharmaceutical Solid Dosage Form.”

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HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

OCTOBER 27, 2022

In this article, we’ll explore some innovations and improvement opportunities in the science, manufacturing processes, and facilities that produce these therapies. Oligos generally have excellent stability in aqueous solutions, and lyophilized oligos are dissolved in aqueous formulation buffers for preparation of the final dosage form anyway.

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The Thyroid Pharmacist

MARCH 10, 2023

I’ve focused a great deal on resolving this with my previous articles on resolving fatigue. I will cover the fundamentals of sleep hygiene for completeness’ sake, but if you’ve been doing ALL of the “basic” things and are still not sleeping, this article will hopefully provide you with additional root cause relief.

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ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. Reader note: This article was originally submitted to Pharmaceutical Engineering® in January 2022.

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Documentation FDA Packaging Communication 52

Pharmaceutical Technology

FEBRUARY 23, 2023

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

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