Results 71 to 80 of about 25,471 (263)
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
Post-Market Surveillance Study of a Skull Flap Fixation Device: Cranfixer
Iranian Journal of Neurosurgery, 2019 Background and Aim: Cranfixer was approved in 2017 by the Food and Drug Administration of Iran as a skull flap fixation and also a burr hole cover.
Seyed Roholah Ghodsi +3 more
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Hallucinatory Side Effects of ADHD Drugs
Pediatric Neurology Briefs, 2009 Clinical trial and postmarketing surveillance data for drugs used in treatment of attention deficit hyperactivity disorder were analyzed to determine the frequency of hallucinations and other psychotic side effects, in a study at the US Food and Drug ...
J Gordon Millichap
doaj +1 more source
Mood, Personality, and Behavior Changes During Treatment with Statins: A Case Series. [PDF]
, 2015 Psychiatric adverse drug reactions (ADRs) have been reported with statin use, but the literature regarding statin-associated mood/behavioral changes remains limited.
Cham, Stephanie +2 more
core +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
Clinical Pharmacology &Therapeutics, EarlyView.Optimal dosing of oncological drugs is historically determined based on the “higher is better” paradigm. However, a paradigm shift in optimal dose selection has occurred in the development of new modalities, including molecularly targeted drugs, antibody drugs, and immunotherapies.
Hiroe Kitagaki +3 more
wiley +1 more source
Postmarketing studies: can they provide a safety net for COVID-19 vaccines in the UK?
BMJ evidence-based medicine, 2020 In the current era of the COVID-19 pandemic, the world has never been more interested in the process of vaccine development. While researchers across the globe race to find an effective yet safe vaccine to protect populations from the newly emergent SARS-
S. Dhanda +3 more
semanticscholar +1 more source
Tapentadol extended release for the management of chronic neck pain [PDF]
, 2017 BACKGROUND: The role of opioids in the management of chronic neck pain is still poorly investigated. No data are available on tapentadol extended release (ER).
Coluzzi, Flaminia
core +1 more source
Muscle &Nerve, EarlyView.ABSTRACT Introduction/Aims An On/Off dosing regimen of intravenous (IV) edaravone and edaravone oral suspension is approved in the US for the treatment of amyotrophic lateral sclerosis (ALS). Placebo‐controlled clinical trials showed IV edaravone slows the rate of physical functional decline.
Jeffrey Rothstein +17 more
wiley +1 more source
Pharmacy Practice, 2006 Objective: The objective of this study was to identify problems in the approval, pharmacovigilance, and post-approval regulatory decision-making procedures involving gefitinib and to propose countermeasures to prevent further drug-induced suffering in ...
Nishimura T, +5 more
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