Safety assessment of cosmetic products, with emphasis on the ocular area: regulatory aspects and validation processes [PDF]
, 2014 Before marketing a cosmetic product, a series of biological assays, such as ocular irritation tests, must be conducted in order to prove that the product is safe.
Cancian, Maythe de Lima +5 more
core +4 more sources
Forced Degradation Study and Development of a Stability-Indicating Method for Amoxicillin Capsules According to ANVISA Guidelines [PDF]
Journal of the Brazilian Chemical Society, 2021 This study aimed to develop a reliable stability-indicating method (SIM) for amoxicillin 500 mg capsules (DP-drug product). A literature review addressing amoxicillin (AMX; DS-drug substance) forced degradation studies and the existing SIMs was conducted to verify the most significant outcomes.
Margareth Gallo +13 more
openaire +2 more sources
T-Cell Memory Responses Elicited by Yellow Fever Vaccine are Targeted to Overlapping Epitopes Containing Multiple HLA-I and -II Binding Motifs [PDF]
, 2013 The yellow fever vaccines (YF-17D-204 and 17DD) are considered to be among the safest vaccines and the presence of neutralizing antibodies is correlated with protection, although other immune effector mechanisms are known to be involved. T-cell responses
AB de Melo +54 more
core +5 more sources
Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia, 2014 Diversas medidas de prevenção dos riscos relacionados à assistência e à melhoria da saúde são desenvolvidas em favor da segurança do paciente.
Heiko Thereza Santana +9 more
doaj +2 more sources
Current development in regulation of similar biotherapeutic products in Brazil [PDF]
, 2011 Because of the recent expiry of a large number of patents on the originator biological products, interest in the production and marketing of similar biotherapeutic products in Brazil has been increasing.
Barbano, Dirceu Brás Aparecido +2 more
core +1 more source
Private umbilical cord blood banks for family use, in Brazil: technical, legal and ethical issues for an implementation analysis [PDF]
, 2010 Os bancos de sangue de cordão umbilical e placentário foram criados a partir da comprovação de que o sangue de cordão umbilical e placentário (SCUP) é uma fonte rica em células progenitoras hematopoéticas (CPH) e alternativa às células provenientes da ...
DE SANTIS, Gil C. +3 more
core +2 more sources
Infarma: Pharmaceutical Sciences, 2020 Com o surgimento da pandemia do coronavirus, houve uma dedicação intensa e relevante da comunidade científica à procura de novos medicamentos para tratamentos da Covid-19, devido à inexistência de vacinas e à necessidade emergencial de se evitar os ...
Anselmo Gomes de OLIVEIRA +1 more
doaj +1 more source
The troubled heparin issue in the Brazilian market and the search for solutions [PDF]
, 2009 Universidade Federal de São Paulo (UNIFESP) Escola Paulista de MedicinaSão Paulo Medical JournalFAMERPUNICAMPUNIFESP ...
Braile, Domingo Marcolino +1 more
core +3 more sources
Análise de Impacto Regulatório: uma nova ferramenta para a melhoria da regulação na Anvisa [PDF]
Revista de Saúde Pública, 2011 A Análise de Impacto Regulatório é recomendada para os órgãos reguladores, a fim de melhorar a qualidade da regulação pela avaliação dos seus custos, benefícios e dificuldades e como subsídio para a tomada de decisão. O artigo analisou a importância da Análise de Impacto Regulatório no contexto da atuação da Agência Nacional de Vigilância Sanitária e ...
Alves, Flávia Neves Rocha, Peci, Alketa
openaire +7 more sources
Cytopathology, EarlyView.The study evaluated the performance of a new liquid preservation medium for cervical samples in DNA‐HPV testing and liquid‐based cytology. The candidate medium demonstrated a 94.5% agreement rate in HPV testing, 92.9% sensitivity for detecting CIN2+ and good performance in liquid‐based cytology.
Larissa Dias Assunção +5 more
wiley +1 more source