Results 81 to 90 of about 19,507 (228)

Long‐Term Safety and Efficacy of Pegvaliase in Japanese Adults With Phenylketonuria: Final Results of a Phase III Trial

JIMD Reports, Volume 67, Issue 3, May 2026.
ABSTRACT Phenylketonuria (PKU) is an inborn error of metabolism leading to phenylalanine (Phe) accumulation and consequent neurological, neurocognitive, and psychiatric symptoms. Pegvaliase, a pegylated recombinant phenylalanine ammonia lyase that metabolizes Phe, effectively reduced blood Phe in phase III studies in the United States. This multicenter,
Yoko Nakajima, Mika Ishige, Tetsuya Ito, Takashi Hamazaki, Mitsuhiro Kuwahara, Lawrence Lee, Haruo Shintaku   +6 more
wiley   +1 more source

Pharmacovigilance in Action: Utilizing VigiBase Data to Improve Clozapine Safety

Patient Preference and Adherence
Carlos De las Cuevas,1 Emilio J Sanz,2,3 Jose de Leon4,5 1Department of Internal Medicine, Dermatology, and Psychiatry and Instituto Universitario de Neurociencia (IUNE), Universidad de La Laguna, La Laguna, Canary Islands, Spain; 2Department of Physical
De las Cuevas C, Sanz EJ, de Leon J
doaj  

Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence

BMJ Open
Objectives To compare the premarket and postmarket evidence of safety and efficacy of direct oral anticoagulants approved for stroke prevention in atrial fibrillation patients across four major regulatory agencies.Design Cross-sectional.Setting European ...
Joseph S Ross, Tianna Zhou, Maryam Mooghali   +2 more
doaj   +1 more source

Post-marketing stability surveillance: Amoxicillin

South African Family Practice, 2006
Background: To ensure the successful treatment of infectious disease using antimicrobial therapy, a sufficient concentration of the stable, active drug is required at the site of infection.
K.K. Naidoo, P. Nompuku, S.N. Mkalali, K. Shabangu, L. Nkabinde, V. Singh   +5 more
doaj   +1 more source

Postmarketing surveillance [PDF]

BMJ, 1994
S, Voss, F, Harris
openaire   +2 more sources

SAFETY EVALUATION OF STATIN IN YOGYAKARTA, INDONESIA [PDF]

, 2009
Background : The 3-hydroxy-3-methylglutaryl-coenzyme (HMG-Co-A) reductase inhibitors, also known as statins, are the most effective class of drugs for lowering serum Low-Density Lipoprotein cholesterol (LDL-c)concentrations.
Anni, Anni, Labado, R.O., Perwitasari, Dyah Aryani, Udu, W.S.A.   +3 more
core  

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

Views of healthcare professionals to linkage of routinely collected healthcare data : a systematic review [PDF]

, 2013
Peer reviewedPublisher ...
Bond, C, Francis, J, Haughney, J, Helms, P J, Hopf, Y M   +4 more
core   +2 more sources

A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims [PDF]

, 2007
This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why ...
Kessler, David A., Vladeck, David C.
core   +1 more source

Agent-based modeling: a systematic assessment of use cases and requirements for enhancing pharmaceutical research and development productivity. [PDF]

, 2013
A crisis continues to brew within the pharmaceutical research and development (R&D) enterprise: productivity continues declining as costs rise, despite ongoing, often dramatic scientific and technical advances. To reverse this trend, we offer various
Hunt, C. Anthony, Hunt, CA, Kennedy, RC, Kim, SHJ, Ropella, GEP   +4 more
core   +2 more sources