Results 51 to 60 of about 25,533 (219)
Clinical Pharmacology in Drug Development, EarlyView.Abstract Sitafloxacin is a new antibiotic drug belonging to the fourth generation quinolone antibiotics. The aim of this study was to evaluate the pharmacokinetics (PK), safety profiles, and bioequivalence of test and reference 50‐mg sitafloxacin tablets under fasting and fed conditions.
Yongfang Lei +13 more
wiley +1 more source
Clinical Pharmacology in Drug Development, EarlyView.Abstract The aim of this study was to evaluate the bioequivalence and safety of a single application of crisaborole ointment to test formulation and reference formulation in healthy subjects under fasting conditions. A total of 32 subjects were included and divided into 2 groups (test‐reference; reference‐test).
Yanchao Wang +9 more
wiley +1 more source
Archives of Medical ScienceConsidering lack of a European standardized postmarketing food supplement surveillance system, some member states and companies have developed their own approaches to monitoring potential AEs to secure a high level of product safety.
M. Banach +9 more
semanticscholar +1 more source
Glycoprotein IIb/IIIa Inhibitors Use and Outcome after Percutaneous Coronary Intervention for Non-ST Elevation Myocardial Infarction [PDF]
, 2014 Aims. We investigate the effect of glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitors on long-term outcomes following percutaneous coronary intervention (PCI) after non-ST elevation myocardial infarction (NSTEMI). Meta-analyses indicate that these agents are
Antoniou, S +9 more
core +4 more sources
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 +2 more
doaj +1 more source
Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations [PDF]
Farmacia Hospitalaria, 2018 Objective: To know the safety profile of the 4CMenB vaccine in adults in special situations. Method: Security prospective study of phase IV. Inclusion criteria and some vaccination conditions were applied.
María Fernández-Prada +5 more
doaj +1 more source
Small, EarlyView.This review presents a detailed overview of clinically approved nanoparticle therapeutics, classifying them by type and discussing their unique advantages in drug delivery. It highlights regulatory challenges across global markets and emphasizes the need for adaptive approval pathways.
Nimeet Desai +5 more
wiley +1 more source
Rotavirus vaccine withdrawal in the United states; the role of postmarketing surveillance.
The Canadian journal of infectious diseases = Journal canadien des maladies infectieuses, 2000 On August 31, 1998, Rotashield (Wyeth Laboratories, Marietta, Pennsylvania) was licensed by the United States Food and Drug Administration for oral administration to infants at two, four and six months of age in the United States. This product is a live,
Gilles Delage
semanticscholar +1 more source
The Science of Safety – An Emerging Concept in Medication Use and Research
INNOVATIONS in Pharmacy, 2016 Most published reports of patient safety in clinical practice focus largely on the culture of safety in complex health systems, separate from pre-approval and postmarketing research-related safety considerations for drugs, biologics, and other medical ...
Shraddha Shinde, MBA student +1 more
doaj +1 more source
Adverse drug reactions induced by cardiovascular drugs in outpatients
Pharmacy Practice, 2008 Considering increased use of cardiovascular drugs and limitations in pre-marketing trials for drug safety evaluation, post marketing evaluation of adverse drug reactions (ADRs) induced by this class of medicinal products seems necessary.Objectives: To ...
Gholami K, Ziaie S, Shalviri G
doaj