Results 81 to 90 of about 49,725 (243)

Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)

open access: yesBioMed Research International, 2017
Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations.
Ana Cerúlia Moraes do Carmo   +3 more
semanticscholar   +1 more source

Assessing HIV trends among blood donors in five Brazilian blood centers: The impact of individual donor assessment

open access: yesTransfusion, Volume 65, Issue 4, Page 685-695, April 2025.
Abstract Background In many countries, including Brazil, time‐based blood donation deferral policies for gay, bisexual, and other men who have sex with men (gbMSM) have been replaced by individual donor assessment (IDA). We examined HIV prevalence and incidence among first‐time (FTD) and repeat donors (RD), comparing data from ~3.5 years before and ...
Renata Buccheri   +11 more
wiley   +1 more source

Real‐World Data and Real‐World Evidence in Regulatory Decision Making: Report Summary From the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII

open access: yesPharmacoepidemiology and Drug Safety, Volume 34, Issue 3, March 2025.
ABSTRACT Data from sources other than traditional randomized clinical trials are known as real‐world data (RWD), and the evidence derived from the review and analysis of RWD is known as real‐world evidence (RWE). RWD and RWE are used increasingly throughout the lifecycle of medicinal products to provide evidence about their effectiveness and safety ...
Sean Hennessy   +50 more
wiley   +1 more source

Nail Polishes: A Review on Composition, Presence of Toxic Components, and Inadequate Labeling

open access: yesDermatology Research and Practice, Volume 2025, Issue 1, 2025.
Nail polishes were developed in 1920, and since 1940, it has been known that these cosmetics contain toxic and sensitizing components. Over the years, nail polishes have undergone several changes in their formulation to avoid this problem, but new components have also been considered toxic and allergenic.
Aislana Cole de Paula   +4 more
wiley   +1 more source

Setting of import tolerances for azoxystrobin in melons and watermelons

open access: yesEFSA Journal, Volume 22, Issue 12, December 2024.
Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Austria to set an import tolerance for the active substance azoxystrobin in melons and watermelons.
EFSA (European Food Safety Authority)   +20 more
wiley   +1 more source

Progress in the environmental risk assessment of plant protection products in Brazil: An overview of birds and mammals and soil organisms proposals

open access: yesIntegrated Environmental Assessment and Management, Volume 20, Issue 6, Page 1793-1799, November 2024.
Abstract Since 2019, the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA) has actively developed pesticide environmental risk assessment (ERA) frameworks adapted to Brazil's specific ecological contexts. This initiative, supported by funding from the Brazilian Ministry of Justice and in partnership with academic institutions ...
Ana Paola Cione   +2 more
wiley   +1 more source

Migration of contaminants from food packages to its content – Brazilian scenario and regulation [PDF]

open access: yes, 2018
Consumers demand pleasant taste and odor in the final food product. Changes in these characteristics may be due to food deterioration or migration of substances from the packaging into food.
Concenço, F. I. (Fernanda)   +3 more
core  

Zinc oxide nanomaterials: Safeguarding food quality and sustainability

open access: yesComprehensive Reviews in Food Science and Food Safety, Volume 23, Issue 6, November 2024.
Abstract In this era, where food safety and sustainability are paramount concerns, the utilization of zinc oxide (ZnO) nanoparticles (NPs) is a promising solution to enhance the safety, quality, and sustainability of food products. ZnO NPs in the food industry have evolved significantly over time, reflecting advancements in synthesizing methods ...
Gökhan Gurur Gökmen   +5 more
wiley   +1 more source

Integration of functional and traditional food in emerging markets. Regulatory and substantive aspects of yerba mate and quinoa [PDF]

open access: yes, 2016
Given the rising cost of healthcare, the increase in life expectancy and the wish for a better quality of life, the request for foods and beverages producing a beneficial effect on health has increased worldwide.
Gafare, Claudia Elena   +3 more
core   +1 more source

Home - About - Disclaimer - Privacy