Results 31 to 40 of about 3,641 (145)

Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis

AAPS Open, 2017
Background While medication labels are considered the authoritative resource for medication information, emerging research suggests that patient-generated health data (PGHD) are a valuable tool to understand the ways in which patients experience ...
David A. Blaser, Stephanie Eaneff, James Loudon-Griffiths, Stephanie Roberts, Paulina Phan, Paul Wicks, James Weatherall   +6 more
doaj   +1 more source

Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

Clinics, 2014
OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify ...
Fabiana Rossi Varallo, Helaine Carneiro Capucho, Cleópatra da Silva Planeta, Patrícia de Carvalho Mastroianni   +3 more
doaj   +1 more source

Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope for the treatment of adult patients with growth hormone deficiency

Therapeutic Advances in Endocrinology and Metabolism, 2012
Objective : To describe the rationale and design of PATRO Adults, a postmarketing surveillance study of the long-term efficacy and safety of somatropin (Omnitrope ® ) for the treatment of adult patients with growth hormone deficiency (GHD).
Paolo Beck-Peccoz, Francesco Minuto, Alfonso Leal-Cerro, Markus Zabransky, Günter Stalla   +4 more
doaj   +1 more source

Safety and Effectiveness of Dulaglutide in the Treatment of Type 2 Diabetes Mellitus: A Korean Real-World Post-Marketing Study [PDF]

Diabetes & Metabolism Journal
Background To investigate the real-world safety and effectiveness of dulaglutide in Korean adults with type 2 diabetes mellitus (T2DM). Methods This was a real-world, prospective, non-interventional post-marketing safety study conducted from May 26, 2015
Jeonghee Han, Woo Je Lee, Kyu Yeon Hur, Jae Hyoung Cho, Byung Wan Lee, Cheol-Young Park   +5 more
doaj   +1 more source

Exposure‐adjusted safety and efficacy of GLP‐I and GLP‐1/GIP receptor agonists compared with non‐GLP‐I for weight management and type 2 diabetes: Based on FDA medical and statistical reports of 34 280 safety and 36 312 efficacy subjects

British Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to contextualize glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists safety and efficacy regarding weight management (WM); we analysed Food and Drug Administration (FDA) Medical Reviews to analyse 14 medications using patient‐exposure year normalization and ...
Aishwarya Prasad, Anshu Arora, Arun Arora, Jeena Vaid, Arif Khan   +4 more
wiley   +1 more source

Enhancing Postmarketing Surveillance of Medical Products With Large Language Models

JAMA Network Open
ImportanceThe Sentinel System is a key component of the US Food and Drug Administration (FDA) postmarketing safety surveillance commitment and uses clinical health care data to conduct analyses to inform drug labeling and safety communications, FDA advisory committee meetings, and other regulatory decisions.
Michael E, Matheny, Jie, Yang, Joshua C, Smith, Colin G, Walsh, Mohammed A, Al-Garadi, Sharon E, Davis, Keith A, Marsolo, Daniel, Fabbri, Ruth R, Reeves, Kevin B, Johnson, Gerald J, Dal Pan, Robert, Ball, Rishi J, Desai   +12 more
openaire   +2 more sources

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

MDDC: An R and Python package for adverse event identification in pharmacovigilance data

Scientific Reports
The safety of medical products continues to be a significant health concern worldwide. Spontaneous reporting systems (SRS) and pharmacovigilance databases are essential tools for postmarketing surveillance of medical products.
Anran Liu, Raktim Mukhopadhyay, Marianthi Markatou   +2 more
doaj   +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

LC-Q-TOF-MS driven identification of potential degradation impurities of venetoclax, mechanistic explanation on degradation pathway and establishment of a quantitative analytical assay method

Journal of Analytical Science and Technology, 2020
Venetoclax is a selective orally active Bcl-2 protein inhibitor very recently approved by USFDA to treat chronic lymphocytic leukemia and other hematological malignancies.
Dhruvisha Pokar, Amit Kumar Sahu, Pinaki Sengupta   +2 more
doaj   +1 more source