Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines [PDF]
, 2018 Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges ...
Anvisa +20 more
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The challenge for ?multilingual? scientists in Brazil [PDF]
, 2014 Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Departamento de OftalmologiaUniversidade Federal de São Paulo (UNIFESP) Departamento de Oftalmologia Disciplina de OftalmologiaHospital das Clínicas da Faculdade de Medicina da ...
Ambrósio Junior, Renato +3 more
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CHARACTERIZATION OF UMAMI TASTE SENSITIVITY IN CHILDREN WITH AND WITHOUT CANCER [PDF]
, 2014 INTRODUCTION: The umami taste comes from glutamate and 5 ribonucleotides including inosinate and guanylate, which appear naturally in many foods. It can be identified by monosodium glutamate, being considered as a subtle taste, but blending well with ...
Elman Ilana +3 more
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A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016 [PDF]
Therapeutic Innovation & Regulatory Science, 2020 Abstract Background The Brazilian health regulatory agency (Agência Nacional de Vigilância Sanitária, ANVISA) has embarked on transformational initiatives to fulfill its mandate to provide timely access to safe, effective, and quality therapeutics. A new Brazilian law was enacted to provide the agency with greater flexibility.
Patel, Prisha +6 more
openaire +2 more sources
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
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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
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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
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Medical devices registration by ANVISA (Agência Nacional de Vigilância Sanitária) [PDF]
Clinics, 2011 Dear Editor, The term “medical devices” covers a wide range of health or medical instruments used directly or indirectly in medicine, dentistry, physical therapy, and laboratory practice for the diagnosis, rehabilitation, therapy, and monitoring of human beings, as well as for aesthetic purposes.
Machado, Aline Fernanda Perez +4 more
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Vitamin Dietary Supplement: Changes and Challenges with the New ANVISA Regulations [PDF]
International Journal of Nutrology, 2021 AbstractIn July 2018, the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA, in Portuguese) published new regulations for food supplements, leading to changes both in the sales denomination and labeling statements, and in the composition of these products.
Lucile Tiemi Abe-Matsumoto +2 more
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Novel thalidomide analogues, “me too” drugs and the Brazilian law / Novos análogos da talidomida, medicamentos “me too” e a lei brasileira [PDF]
, 2013 In Brazil, thalidomide has been used virtually without interruption since it was launched as a new and revolutionary sedative drug in 1956. After 1965, when its effi cacy to treat erythema nodosum leprosum (ENL) was discovered, it was regarded as an ...
Francisco José Roma Paumgartten
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