Agent-based modeling: a systematic assessment of use cases and requirements for enhancing pharmaceutical research and development productivity. [PDF]
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 +4 more
core +2 more sources
Recent advances: rheumatology [PDF]
No abstract ...
Madhok, R., Kerr, H., Capell, H.A.
core +4 more sources
Characteristics of Patients with Hereditary Transthyretin Amyloidosis and an Evaluation of the Safety of Tafamidis Meglumine in Japan: An Interim Analysis of an All-case Postmarketing Surveillance [PDF]
Tomonori Ishii +6 more
openalex +1 more source
Tacrolimus in Patients With Interstitial Pneumonia Associated With Polymyositis or Dermatomyositis: Interim Report of Postmarketing Surveillance in Japan [PDF]
Masataka Kuwana +4 more
openalex +1 more source
MDDC: An R and Python package for adverse event identification in pharmacovigilance data
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 +2 more
doaj +1 more source
Objective The objective of this study was to report the incidence of uveitis in secukinumab‐treated patients with ankylosing spondylitis (AS) in a pooled analysis of three phase 3 trials (MEASURE 1‐3 [ClinicalTrials.gov identifiers NCT01358175 ...
Atul A. Deodhar +11 more
doaj +1 more source
SAFETY EVALUATION OF STATIN IN YOGYAKARTA, INDONESIA [PDF]
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 +3 more
core
The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements [PDF]
The United States Food and Drug Administration (FDA) has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs
Naci, Huseyin +2 more
core +1 more source
Dalfampridine extended release tablets: 1 year of postmarketing safety experience in the US
Michele Jara,1 Graham Barker,2 Herbert R Henney 3rd1 1Acorda Therapeutics, Inc, Ardsley, NY, USA; 2Biogen Idec, Inc, Maidenhead, Berkshire, UK Background: Dalfampridine extended release tablets (dalfampridine-ER; prolonged-, modified, or sustained ...
Jara M, Barker G, Henney 3rd HR
doaj

