Results 111 to 120 of about 22,949 (256)

Prescription Sequence Symmetry Analysis of Glucagon‐Like Peptide‐1 Receptor Agonists and Neuropsychiatric Conditions

Clinical Pharmacology &Therapeutics, EarlyView.
Glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) are increasingly prescribed for type 2 diabetes and weight management. However, conflicting evidence from preclinical, clinical, and pharmacovigilance studies suggests potential neuropsychiatric effects.
Maria J. Alfonso Arvez, Sam Wade, Darshna Goordeen, Jenni Ilomäki, Amanda J. Cross, Monica Langiu, George S. Q. Tan   +6 more
wiley   +1 more source

The Multiple Criteria Qualitative Value‐Based Pricing Framework “MARIE” for Novel Cell and Gene Therapy

Clinical Pharmacology &Therapeutics, EarlyView.
When setting the price of cell and gene therapies in Japan, the factors considered include the manufacturing and operating costs of the new drug or a comparator, leading to discrepancies between price and values, in particular those specific to cell and gene therapies.
Akina Takami, Ataru Igarashi
wiley   +1 more source

Adverse Reactions Identified after Approval of Novel Medicines: Analysis of 339 New Molecular Entities and Therapeutic Biologics

Clinical Pharmacology &Therapeutics, EarlyView.
Postmarketing safety surveillance data identify safety issues not identified in preapproval clinical trials. We describe the frequency of new safety issues overall and by labeling section and the relationship of the most commonly added safety issues with the cumulative number of prescriptions dispensed via retail pharmacies.
Ellen Pinnow, Brendan Day, Esther H. Zhou, Corinne Woods, Nana Dwumfour, Jenni Y. Lee, Ilynn Bulatao, Sanae Cherkaoui, Manish Kalaria, Sonja Brajovic, Nabila Sadiq, Farideh Sistani, Maggie Lee, Grace Chai, Gerald Dal Pan   +14 more
wiley   +1 more source

Post-Marketing Surveillance [PDF]

Journal of the Royal Society of Medicine, 1979
openaire   +1 more source

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

Clinical Pharmacology &Therapeutics, EarlyView.
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, José M.A. Moreira   +1 more
wiley   +1 more source

The Human and Environmental Side of HRM: A Systematic Review and Future Research Agenda

Corporate Social Responsibility and Environmental Management, EarlyView.
ABSTRACT Green Human Resource Management (GHRM) has received growing attention as organisations are leveraging HRM to address environmental and social challenges. Although prior research links GHRM to improved environmental and organisational performance, much of this literature focuses on performance‐oriented outcomes and gives limited attention to ...
Matilda Forkuo‐Dwomoh, Desmond Tutu Ayentimi, Roshni Narendran   +2 more
wiley   +1 more source

Analysis of Mandatory Post-Marketing Surveillance Studies Supports Revised Regulatory Requirements in Korea. [PDF]

Pharmacoepidemiol Drug Saf
Wolter K, Jeong SH, Woo JW, Kim E, Lee Y, Cha S, Moy E, Junor R.   +7 more
europepmc   +1 more source

Micro‐QuEChERS Extraction for Broad‐Spectrum LC‐QQQ‐MS Quantification of Nitazene Analogs in Plasma: A Validated Method With Casework Application

Drug Testing and Analysis, EarlyView.
Micro‐QuEChERS sample preparation coupled to LC‐QQQ‐MS enabled sensitive quantification of nitazene analogs in 100 μL of plasma. The validated method provided low detection limits and was successfully applied to an authentic intoxication case involving N‐pyrrolidino protonitazene, supporting clinical and forensic toxicology workflows.
Karla A. O. Souza, Náthaly C. B. F. Santos, Rafael Lanaro, Sara E. Walton, Alex J. Krotulski, Barry K. Logan, Mauricio Yonamine, Jose Luiz Costa   +7 more
wiley   +1 more source

Thrombotic Events in Patients With Paroxysmal Nocturnal Haemoglobinuria Using Eculizumab: A Post-Marketing Surveillance Sub-Analysis. [PDF]

EJHaem
Ikezoe T, Kawaguchi T, Hayashi H, Shimono A, Nishimura JI.   +4 more
europepmc   +1 more source

Antidepressant Misuse in Esports: A Review of Pharmacology, Adverse Effects, Pharmacokinetics and Biomatrix‐Based Detection for Anti‐Doping Applications

Drug Testing and Analysis, EarlyView.
This review highlights the misuse of antidepressants as potential cognitive‐enhancing agents in Esports. Despite pharmacological effects that overlap with those of psychostimulants, antidepressants remain an under‐recognised source of doping in Esports.
Kassim Ali Salum, Shao‐Hsin Hung, Meng‐Tsang Hsieh, Mei‐Chich Hsu, William Chih‐Wei Chang   +4 more
wiley   +1 more source