The Thyroid Pharmacist

JUNE 14, 2023

In honor of Father’s Day, I want to recirculate my original Men’s Health article — with some updates. This article is dedicated to all of the special men in your life. (I You may have seen this article last year, around this time — some things have changed! His wife had Hashimoto’s.)

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PQA

AUGUST 8, 2022

Between 2019 and 2021, PQS has significantly contributed to the industry’s further understanding of how to utilize pharmacy as a clinical practice by helping to bring awareness of the impact pharmacy staff can have on their communities.

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IDStewardship

AUGUST 29, 2022

In this article, an antimicrobial stewardship pharmacists provides five tips for new pharmacists. Article Posted 1 September 2022. References (articles that I cited in my blog post). United States of America: Centers for Disease Control and Prevention; [reviewed 2019 Dec 30; cited 2022 Aug 27]. SHsieh_rx on Twitter.

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pharmaphorum

MAY 26, 2022

For instance, in 2019, the Pharmacovigilance Risk Assessment Committee recommended that the marketing authorizations for fenspiride medicines be revoked, despite high efficiency in treating coughs, because fenspiride could cause heart rhythm problems. . This must be monitored, understood not to miss something important”, he adds. .

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The Checkup by Singlecare

DECEMBER 1, 2023

The FDA maintained this stance in 2019 after its Food Advisory Committee (FAC) reviewed the available evidence on color additives like Red 40 and their impact on children’s behavior. But his suggestions were dismissed.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published November 2019. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 Published 15 November 2021. 8] The proposed comprehensive QOS fulfills these conditions.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published November 2019. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. The authors propose using Module 2.3 Published 15 November 2021. 8] The proposed comprehensive QOS fulfills these conditions.

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ISPE

JANUARY 9, 2023

Hayes Marc Ramoneda Rueda 1 January 2023 In this article, potential Pharma 4.0™ This article is the second part of the “Reimagining CPV for a Pharma 4.0™ ™ World” article published in the May–June 2022 issue of Pharmaceutical Engineering ® . 1 In that article, the business requirements were analyzed. are discussed.

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ISPE

OCTOBER 27, 2022

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). However, for certain DHTs classified as devices or SaMD, ISO 14971:2019 specifies the terminology, principles, and process for application of risk management. tools (DHTTs).

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ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Pharmaceutical Engineering (May/June 2019).

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ISPE

OCTOBER 27, 2022

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). However, for certain DHTs classified as devices or SaMD, ISO 14971:2019 specifies the terminology, principles, and process for application of risk management. tools (DHTTs).

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The People's Pharmacy

MAY 8, 2023

In fiscal year 2019, the year before the COVID-19 pandemic limited travel and movement, the FDA inspected 37% of the nearly 2,500 overseas manufacturers; in 2022, the agency only inspected 6% of around 2,800.” According to ProPublica, the FDA visited 45% of the pharmaceutical plants there in 2019. Here’s the kicker.

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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. 2 October 2019. 11 September 2019. 6 November 2019.

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pharmaphorum

JANUARY 28, 2022

But never mind, 2021 was a blockbuster even compared to 2020 or 2019, with many sources saying there was twice as much, or nearly twice as much money raised this past year compared with the year before. In this article I’m looking at four 2021 healthcare funding reports: CB Insights, StartUp Health, Rock Health, and Silicon Valley Bank.

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ISPE

SEPTEMBER 11, 2023

This article provides background knowledge from literature and data from experiments to enhance the discussion. The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 ASHRAE Journal (2019): 38–54. Cleanrooms and Associated Controlled Environments—Part 3: Test Methods” 2019.

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pharmaphorum

FEBRUARY 9, 2021

In the final instalment of our series reviewing the t he 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), Leela Barham takes stock of the whole scheme after digging more deeply into its three objectives. It makes for an agreement which is neither a legal document nor a policy one. About the author.

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ISPE

MAY 11, 2023

Also, determining whether an intrusion occurred and documenting that intrusion adds to the challenges of performing aseptic technique properly (and perhaps adds to the subjectivity of the current control strategies). link] 7 ISO Standard 14971:2019. December 2019. ICH Harmonised Tripartite Guideline Q9: Quality Risk Management.”

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The Thyroid Pharmacist

JUNE 16, 2023

This article will explain how black seed oil, which has grown in popularity in the medical world, may be a game changer and get you one step closer to putting Hashimoto’s into remission. In this article, you will learn: What is black seed oil? Published 2019 May 12. Avicenna J Phytomed. 2016;6(1):21-33. [23] Nigella sativa L.

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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. In 2019, FDA released the draft guidance Quality Considerations for Continuous Manufacturing. 3 (2019): 253–67. Lee, and S. Gyurkes, A.

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ISPE

SEPTEMBER 10, 2023

In this article, we describe the assessment of lag time for global regulatory approvals of postapproval CMC changes for multiple products over a three-year period. en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf 9 European Commission.

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ISPE

OCTOBER 26, 2022

This article outlines a broad framework to evaluate different types of modalities that may be accommodated concurrently in a new or existing facility and then uses a case study to explain how the approach may be applied to an existing facility. For the purposes of brevity, this article doesn’t discuss safety.

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European Pharmaceutical Review

SEPTEMBER 22, 2022

This article will explore the advantages of using HCs, as well as several considerations for their effective use, including scientific methodology and regulatory guidance. NICE DSU technical support document 18: methods for population-adjusted indirect comparisons in submissions to NICE. Benefits of historical controls. Patel et al.

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European Pharmaceutical Review

JULY 1, 2022

The PSCI encourages commitment and accountability, as well as documentation. The government held an ethnicity pay reporting consultation in 2018 that closed in 2019 and, although a response is yet to be published, one is expected soon. No draft ordinance or order has been publicised as of the date of writing this article.

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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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ISPE

JULY 10, 2023

For the sake of readability, we will use it interchangeably for both interpretations throughout the article. Our article concludes with an outlook on how the use of LLMs may evolve, beyond the current hype. ChatGPT is commonly used to refer to the chatbot web interface, and the underlying model.

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ISPE

JANUARY 8, 2023

Lecture Notes in Computer Science 11700 (2019) Springer, Cham. In this article, we elaborate on the benefits and requirements on xAI from a GxP point of view, along with the development and production process, with a focus on strategies to ensure that the intention of use is met and to manage risks for safety that arise from xAI itself.

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ISPE

MAY 10, 2023

1 May 2023 Funded by the European Commission from 2019, the Smart Pharmaceutical Manufacturing Project (SPuMoNI) 1 harnesses the potential of state-of-the-art technologies for the pharmaceutical industry. This article discusses the main SPuMoNI accomplishments. Chis, Ph.D. Horacio Gonzalez-Velez, Ph.D. SPuMoNI homepage.

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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. vs. 398 U/mL). [1]

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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. 8 (November/December 2019):26–29. 3 (May/June 2019):10–21. Gerogiorgis, R.

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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. Published November 2019. 22 June 2023. EMA/321483/2020. 3 July 2020.

FDA 52

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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. and the impact on supply resiliency.

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The Thyroid Pharmacist

JULY 29, 2022

In this article, you will learn: How we are exposed to unhealthy air quality, indoors and outdoors. This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Check out my article on mold toxicity to learn more about reducing mold in your home. (I How airborne toxins can affect the thyroid.

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ISPE

MARCH 7, 2023

This article reviews two case studies that cover sustainable pack types and extension of shelf life. Published November 2019. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” 5 (2019): 517–521. Press Release.

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The Spirit Pharmacist

FEBRUARY 21, 2023

There have been a couple of small case series document LSD use in pregnancy and normal birth outcomes, although these are not high quality or conclusive by any means [23]. Clin Obstet Gynecol, 2019. Nevertheless, several case reports of ophthalmic or limb abnormalities born to mothers who used LSD exist in medical literature [19-22].

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Pharma Marketing Network

APRIL 30, 2021

At the time of writing this article, a search of clinicaltrials.gov found as many as 1,066 active or completed studies that include wearable devices. The rising popularity of these consumer wearables has been paralleled by a sharp increase in the use of digital technologies, including wearables, in clinical trials.

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ISPE

NOVEMBER 1, 2022

Quality management maturity (QMM) entered the discussion on ways to address the challenges in 2019 in the FDA report, “ Drug Shortages: Root Causes and Potential Solutions. ” Disclaimer : This article contains an abridged, unofficial summary of an FDA regulator’s presentation at a conference that has not been vetted by the agency.

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The Thyroid Pharmacist

DECEMBER 7, 2022

In this article, you will learn: How your family is exposed to flame retardants. On a positive note (and why I wrote this article), there are ways to reduce the prevalence of these chemicals in your home and reduce the toxic load in your body. Read this article about NAC for more information about how it can support thyroid health. [32].

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