Pharmacy Times

JUNE 11, 2025

1,2 Image Credit: © stockdevil - stock.adobe.com Results from 2 single-dose, open-label, randomized phase 1 crossover studies of healthy adults served as the basis for this approval. These trials were designed to establish bioequivalence between zanubrutinib capsules and zanubrutinib tablets.

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Pharmacy Times

JUNE 11, 2025

Its efficacy was evaluated in the 2 multicenter, single-arm open-label phase 2 clinical trials TRUST-I (NCT04395677) 3 and TRUST-II (NCT04919811). Taletrectinib is an oral, potent, central nervous system (CNS)–active, selective, next generation ROS1 inhibitor approved for the treatment of adults with advanced ROS1+ NSCLC.

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Pharmacy Joe

SEPTEMBER 7, 2022

Milrinone labeling suggests a renal dose adjustment for patients with creatinine clearance between 10 and 50 mL/min but has no recommendations or data available for patients with ESRD or who are receiving CRRT.

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Pharmacy Joe

FEBRUARY 15, 2023

Such a recommendation, even though it is labeled as weak and based on very low-quality evidence is likely to make its way into hospital protocol in the form of automatically discontinuing a C diff test for a patient with recent laxative use. Members of my Hospital Pharmacy Academy have access to practical trainings on C.

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Pharmacy Joe

OCTOBER 3, 2021

A group of authors recently published in NEJM the results of a randomized, multicenter, open-label, parallel-group trial in the UK examining this issue. If your department does not handle albumin use, consider passing this article on to the physician chief who supervises the laboratory department that handles requests for albumin.

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Pharmacy Times

JUNE 23, 2025

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. In the 505(j) ANDA approval pathway, on the other hand, submissions can be multisource generic drugs; however, this pathway requires bioequivalence to the RLD.

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Pharmacy Joe

SEPTEMBER 7, 2022

Milrinone labeling suggests a renal dose adjustment for patients with creatinine clearance between 10 and 50 mL/min but has no recommendations or data available for patients with ESRD or who are receiving CRRT.

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Pharmacy Times

JUNE 27, 2025

Although no formal contraindications are listed in AstraZeneca’s US labeling, perioperative management may require holding acalabrutinib 3 to 7 days before and after surgery to minimize bleeding risk. Hepatotoxicity and drug-induced liver injury are additional risks that require monitoring. Cancer Therapy Advisor. June 21, 2024.

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