Results 71 to 80 of about 5,946 (190)
Incentivizing the Utilization of Pharmacogenomics in Drug Development [PDF]
Pharmacogenomics, the study and development of compounds according to how an individual’s genes affects the body’s response to drugs, holds enormous promise for increasing the safety and efficiency of drug development while decreasing adverse reactions ...
Koch, Valerie Gutmann
core +1 more source
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
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O objetivo desta revisão foi explorar e comparar as informações derivadas de estudos prospectivos sobre a incidência de reações adversas a medicamentos (RAM) em pediatria, publicados de janeiro de 1966 a novembro de 2003 em revistas indexadas nas bases ...
Djanilson Barbosa dos Santos +1 more
doaj +1 more source
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 +6 more
wiley +1 more source
Unlicensed and off-label prescription of respiratory drugs to children [PDF]
Many respiratory drugs are not available in formulations suitable for infants and toddlers. Efficacy and safety research is mostly restricted to older children.
Anker, J.N. (John) van den +4 more
core +3 more sources
Abdel Naser Zaid,1 Masshour Ghanem,2 Dua’a Shweiki,1 Hala Shtewi,1 Raja’ Shaheen,1 Sondos Al Helaly,1 Zeina Khayyat,1 Rowa’a Al Ramahi,1 Sa’ed H Zyoud1 1Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah ...
Zaid AN +8 more
doaj
Viloxazine, a serotonin–norepinephrine modulating agent, has been repurposed from an antidepressant to a novel non‐stimulant for ADHD. Its multimodal mechanism and Phase II/III trials demonstrate clinically meaningful symptom reduction with a distinct safety and interaction profile, offering an alternative for patients who cannot tolerate stimulants ...
Ghaith K. Mansour +4 more
wiley +1 more source
ABSTRACT Background and Aims Drug‐induced dystonia is a serious, potentially disabling adverse event (AE) associated with certain medications. Despite its clinical relevance, the existing literature is largely limited to case reports or analyses of individual drugs, and a systematic evaluation of medications implicated in dystonia remains lacking. This
Chunhua Chen +6 more
wiley +1 more source
DRUG THERAPY AND PREGNANCY: UNKNOWN RISKS LEAD TO HARD CHOICES [REDACTED VERSION] [PDF]
This paper is a proposal to improve the quality of information available to pregnant patients in selecting treatment options. By providing drug companies with extended grants of exclusivity, the FDA has the ability to empower pregnant women to take ...
Goldstein, Lori M.
core
OBJETIVOS: Descrever e avaliar o Sistema brasileiro de vigilância passiva de eventos adversos pós-vacinação (SPVEAPV). MÉTODOS: A descrição e avaliação do SPVEAPV fundamentaram-se nas notificações de eventos adversos pós-vacina Tetravalente ou DTwP/Hib -
Sandra Aparecida Moreira Gomes Monteiro +2 more
doaj +1 more source

