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New Bill could enhance UK clinical trial regulation

European Pharmaceutical Review

He highlighted research by the Association of the British Pharmaceutical Industry (ABPI) from 2022, which found that between 2018 and 2020, “the median time between application for regulatory approval and delivery of a first dose to a participant in a trial increased by almost a month.”

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Anaemia in Chronic Kidney Disease

RX Note

External Links KDIGO CPG for Anemia in Chronic Kidney Disease, 2012 KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease, 2006 KDOQI US Commentary on the 2012 KDIGO Clinical Practice Guideline for Anemia in CKD, 2013 Recombinant human erythropoietins: very rare risk of severe cutaneous adverse (..)

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Drug Allergy

RX Note

A person who takes a certain drug may experience rashes, while another person who takes the same drug may not have any adverse reactions. Collectively, drug allergy, intolerance and nonimmune drug hypersensitivity reactions have been estimated to comprise 25% of all adverse drug events.

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Hypertension

RX Note

Resistant Hypertension Resistant hypertension is defined by a patient whose BP is not controlled on three or more drugs (including a diuretic). After excluding medication non-adherence and isolated office hypertension, a quick check on the possible causes of resistant is required.

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The 7 Most Common Nutrient Deficiencies in Hashimoto’s

The Thyroid Pharmacist

Most people with Hashimoto’s have deficiencies in these nutrients, and I’ve seen very limited adverse reactions with supplementation (please check the special considerations/cautions sections under each supplement heading to learn about adverse reactions). (12-16). Published 2018 Mar 20. Published 2018 Jul 2.

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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

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Timing of Medication

RX Note

Selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors can cause either activating or sedating adverse reactions. Some adverse reactions can be used as an advantage. 2018 What time of day should I take my medicine?,