Results 61 to 70 of about 10,049 (144)

Safety Issues With the Use of Antimicrobials in Current Clinical Practice [PDF]

open access: yesКлиническая микробиология и антимикробная химиотерапия, 2015
Due to increased use of antibiotics in current clinical practice it is very important to evaluate all risks of antimicrobial therapy. Pharmacovigilance plays a vital role in ensuring that doctors, together with the patient, have enough information about ...
Kuzmina A.V.   +3 more
doaj  

Operationalizing Precision Medicine in Drug Development: Predictive Biomarkers, Companion Diagnostics, and Regulatory Pathways

open access: yesClinical Pharmacology &Therapeutics, Volume 120, Issue 4, Page 914-929, October 2026.
Precision medicine offers the opportunity to improve the benefit–risk profile of new therapies by prospectively identifying patients most likely to respond or least likely to experience harm; however, its systematic integration into drug development remains inconsistent outside oncology.
Ingrid Holst‐Laubjerg   +1 more
wiley   +1 more source

Cyclooxygenase-2 inhibitors: promise or peril?

open access: yesMediators of Inflammation, 2002
The discovery of two isoforms of the cyclooxygenase enzyme, COX-1 and COX-2, and the development of COX-2-specific inhibitors as anti-inflammatories and analgesics have offered great promise that the therapeutic benefits of NSAIDs could be optimized ...
Laurel J. Mengle-Gaw   +1 more
doaj   +1 more source

Beyond Blind Trust in Hospital Data Warehouses: Evaluating Real‐World Data Accountability

open access: yesLearning Health Systems, Volume 10, Issue 4, October 2026.
ABSTRACT Introduction The reliability of real‐world evidence (RWE) depends on data accuracy and secondary users' ability to evaluate how data are generated and transformed. Although recent frameworks emphasize provenance, transparency, and auditability, their practical assessment in routine hospital settings remains unclear.
Akemi Morohashi   +6 more
wiley   +1 more source

Long‐Term Safety and Efficacy of Obeticholic Acid in Patients With Primary Biliary Cholangitis: Final Results of the POISE Long‐Term Safety Extension

open access: yesAlimentary Pharmacology &Therapeutics, Volume 64, Issue 8, Page 1083-1096, October 2026.
In the POISE open‐label extension, patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid received long‐term obeticholic acid (OCA) treatment. Findings demonstrated a safety profile consistent with the known characteristics of OCA, with no unexpected safety signals, while supporting sustained efficacy ...
Christopher L. Bowlus   +8 more
wiley   +1 more source

Beyond the CE Mark: A Call to Action for Minimum CGM Accuracy Standards in Central and Eastern European Nations

open access: yes
Diabetes, Obesity and Metabolism, EarlyView.
Tomasz Klupa   +14 more
wiley   +1 more source

Target‐Specific Dermatological Adverse Event Reporting With T‐Cell–Engaging Bispecific Antibodies: A Pharmacovigilance Analysis of FAERS and Canada Vigilance, 2016–2026

open access: yesCancer Medicine, Volume 15, Issue 9, September 2026.
ABSTRACT Background T‐cell–engaging bispecific antibodies are increasingly utilised in haematological malignancies and are beginning to be adopted in solid‐tumour treatment protocols. Cytokine release syndrome and neurotoxicity are well recognised, but target‐specific dermatological adverse event reporting patterns remain poorly defined.
Saikat Mandal   +2 more
wiley   +1 more source

Trends in the use of validated claims-based algorithms in Japanese post-marketing database studies

open access: yesFrontiers in Pharmacology
BackgroundIn pharmacoepidemiological research, misclassification is a concern with claims-based algorithms (also called computable phenotypes). Validating them is crucial, particularly within regulatory settings.
Chieko Ishiguro, Takahiro Nonaka
doaj   +1 more source

Dimethyl Fumarate‐Associated Acute Hepatocellular Injury Assessed for Causality Using the Updated RUCAM: A Biopsy‐Supported Case Report

open access: yesClinical Case Reports, Volume 14, Issue 9, September 2026.
ABSTRACT Dimethyl fumarate may rarely cause severe hepatocellular injury. In a 26‐year‐old woman, liver enzymes rose soon after treatment initiation, and biopsy supported DILI. Updated RUCAM assessment yielded 6, indicating probable causality, supported by dechallenge.
Ophir Lavon, Maram Salameh
wiley   +1 more source

Payload‐Based Clinical Pharmacology Review of Approved Antibody–Drug Conjugates: Commonalities and Considerations for Streamlined Development

open access: yesClinical Pharmacology &Therapeutics, Volume 120, Issue 3, Page 614-638, September 2026.
Antibody–drug conjugates (ADCs) combine the specificity of an antibody with the potency of a cytotoxic drug. Thirteen ADCs, utilizing seven unique cytotoxic payloads and targeting 11 distinct antigens, are currently approved by the US Food and Drug Administration as of June 2025, representing a rapidly growing and highly promising class of anticancer ...
Sijie Lu   +6 more
wiley   +1 more source

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