Good Regulatory Practice
Mostrando 1-5 de 5 artigos, teses e dissertações.
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1. Application of statistical process control for spotting compliance to good pharmaceutical practice
ABSTRACT For the release of pharmaceutical products into the drug market; most of the pharmaceutical companies depend on acceptance criteria - that are set internally, regulatory and/or pharmacopeially. However, statistical process control monitoring is underestimated in most quality control in cases; although it is important not only for process stability a
Braz. J. Pharm. Sci.. Publicado em: 26/07/2018
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2. Limitações à reprodução assistida - a mercantilização da espécie humana: regras do biodireito e da bioética - a necessidade de legislação específica
The law currently is facing a need in the world, both countries small, medium or large development, which is the implementation of legal system to evaluate cases with disputes arising in the Assisted Human Reproduction. The lack of specific legislation, makes any fragile situation of the people, whether in the actual practice of assisted human reproduction,
Publicado em: 2010
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3. REGULAMENTAÇÃO TÉCNICA: PROPOSIÇÃO DE UM CÓDIGO MÍNIMO DAS BOAS PRÁTICAS E DIAGNÓSTICO DO SISTEMA BRASILEIRO / TECHNICAL REGULATION: PROPOSITION OF A MINIMUM CODE OF THE GOOD REGULATORY PRACTICES AND DIAGNOSIS OF THE BRAZILIAN SYSTEM
Objetivo: Proposição de um código mínimo das boas práticas da regulamentação técnica com vistas a disciplinar o desenvolvimento e a aplicação de regulamentos e assegurar que estes somente sejam introduzidos quando justificados com base em objetivos legítimos e em benefício da eficiência de qualquer sistema regulatório, com o propósito de evita
Publicado em: 2007
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4. EMEA and Gene Therapy Medicinal Products Development in the European Union
The evaluation of quality, safety, and efficacy of medicinal products by the European Medicines Evaluation Agency (EMEA) via the centralized procedure is the only available regulatory procedure for obtaining marketing authorization for gene therapy (GT) medicinal products in the European Union. The responsibility for the authorization of clinical trials rem
Hindawi Publishing Corporation.
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5. Immunomagnetic isolation of CD4+CD25+FoxP3+ natural T regulatory lymphocytes for clinical applications
Although CD4+/CD25+ T regulatory cells (Tregs) are a potentially powerful tool in bone marrow transplantation, a prerequisite for clinical use is a cell-separation strategy complying with good manufacturing practice guidelines. We isolated Tregs from standard leukapheresis products using double-negative selection (anti-CD8 and anti-CD19 monoclonal antibodies
Blackwell Science Inc.