ISPE

JULY 5, 2023

This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization. End-to-end continuous processes flow from starting materials to finished dosage forms. Updated 19 April 2016. 4 a b Byrn, S., Jayjock, N.

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ISPE

MARCH 8, 2023

This article proposes recommendations for industry and RAs to address the identified problems. Microbial Contaminants From 2007 to 2021, 90 cases of contamination due to microorganisms were reported, with 61 caused by bacteria, 5 , 6 , 7 , 8 , 9 , 10 , 23 by viruses, 11 , 12 and 6 by fungi. 6 (2021): 2923–2936. link] 3 Liu, H.,

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Viseven

SEPTEMBER 14, 2023

Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. Prior to e-procurement, GlaxoSmithKline (GSK) , a global pharma brand, used old school paper cataloguing and communications over the phone.

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The Thyroid Pharmacist

JANUARY 6, 2023

The past few years have been so hard on many of us, including me, and I wanted to share this article with you, with the hope that it will offer you some new information to help you cope if you are struggling with depression. This article focuses on some of the low-hanging fruits that can help many people with depression feel better.

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The Checkup by Singlecare

DECEMBER 6, 2023

Propylene glycol is primarily limited to injectable and rectal dosage forms of some medications, including diazepam, digoxin, lorazepam, phenobarbital, phenytoin, and sulfamethoxazole. When to talk to a healthcare provider about metronidazole interactions This article is not a complete list of metronidazole interactions.

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The Checkup by Singlecare

FEBRUARY 6, 2024

In that case, close observation is necessary for signs of withdrawal upon discontinuing fluconazole, and there might be a need to adjust the fentanyl dosage. Breastfeeding women prescribed fluconazole should openly communicate the risks and benefits, or possible alternatives, with their medical provider.

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The Checkup by Singlecare

JANUARY 12, 2024

Therefore, any onset of symptoms should be managed by immediate communication with a healthcare professional. Some dosage forms of ondansetron contain sodium benzoate, a metabolite of benzyl alcohol. When to talk to a healthcare provider about ondansetron interactions This article is only a partial list of ondansetron interactions.

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The Checkup by Singlecare

FEBRUARY 8, 2024

If deemed necessary to combine, the dosages and durations of the contributing medications should be reduced and kept to a minimum. When to talk to a healthcare provider about olanzapine interactions This article is not a complete list of olanzapine interactions nor a complete list of possible side effects.

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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. 1 (2021):48. 6540 (2021):341–42. 3 a b c Algorri, M.,

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The Thyroid Pharmacist

OCTOBER 6, 2023

Thus, this article was due for an update, as it was initially published in 2019. Many readers in my community report symptoms of histamine intolerance, which can be challenging to differentiate from other food sensitivities and imbalances in the digestive system. It took me some time to sort everything out and get to my root causes.

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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. These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Humic extract, the main ingredient, contains fulvate, which helps the cells in our gut better communicate with each other and bacteria.

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ISPE

MARCH 29, 2023

Published 15 November 2021. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g., The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

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ISPE

MARCH 29, 2023

Published 15 November 2021. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g., The authors propose using Module 2.3 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

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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. The information required in these declarations include product information (name, strength, dosage form), manufacturer, packager and license holder, and drug product manufacturing site name and country.

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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. 16 (20 September 2021): 9026–41. You may unsubscribe from these ISPE communications at any time. Figure 1 shows a typical block flow sequence of unit operations.

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ISPE

MAY 10, 2023

This article discusses the main SPuMoNI accomplishments. 6 (Note: The terms “pharmaceutical” and “pharma” interchangeably employ throughout this article.) End-to-End Continuous Manufacturing of Pharmaceuticals: Integrated Synthesis, Purification, and Final Dosage Formation.” Big Data Research 24 (15 May 2021): 100172.

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The Thyroid Pharmacist

JANUARY 13, 2023

In this article, I’ll discuss: What is the connection between thyroid issues and adrenal dysfunction? 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] What causes adrenal dysfunction?

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ISPE

SEPTEMBER 8, 2023

This article describes the goal of the initiative, characterizes the anticipated challenges to innovation, summarizes the industry’s need to innovate, and discusses regulatory initiatives that are currently in progress, including learnings from the recent pandemic. 11 June 2021. Innovative Manufacturing Technology WG (IMT-WG).”

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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). This article highlights the regulatory expectations of raw materials, the challenges of postapproval changes. 5 (September/October 2021). and the impact on supply resiliency.

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The Thyroid Pharmacist

FEBRUARY 10, 2023

In this article, you’ll learn: Common causes behind low libido (and how the thyroid can affect this) Why conventional approaches to low libido don’t typically work in those with Hashimoto’s Natural solutions to increase low libido in both men and women What is Libido, and What Can Affect It? There are many natural solutions.

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The Thyroid Pharmacist

JANUARY 20, 2023

For the purposes of this article, I’d love to do a deep-dive focus on adaptogenic herbs, as one way to increase our body’s resilience and lower the impact of all types of chronic stress. This article features a long list of adaptogens, each of which has fascinating and unique properties.

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