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This thesis explores the effectiveness of the Food and Drug Administration’s implementation of Breakthrough Therapy Designation (BTD), focusing on the low number of approval rates and repercussions of BTD for the development of new drugs for patients suffering serious life threatening illnesses. BTD, as an expedited review process, shows potential for improvement in its guidelines for necessary qualifications for BTD. Cutting costs, through a shortening in development time, and raising profits, through first mover status of new to market drugs, BTD is regarded by pharmaceutical executives as a tool to insure not only return on investment but also the rewards that accompanies a profitable blockbuster drug. Lessons learned from activism from 1980’s HIV/AIDS crisis show how advocates and “activist-experts” can rebalance and refocus more attention on the necessary beneficence for patients. A policy stipulation that insures all members: corporate, regulatory, and patient advocate, sit together at the decision making table will insure a more balanced discussion in regards to drug development.

Class of 2010 Abstract / OBJECTIVES: The objective was to compare differences in weight loss data presented in published orlistat studies on orlistat to their corresponding studies submitted to the FDA. METHODS: This meta-­‐analysis compared one-­‐year weight loss data reported in six published orlistat 120 mg studies to data reviewed by the FDA in the New Drug Application (NDA). The primary dependent variables were the percentage of subjects achieving 5% and 10% weight loss. Prior to analysis, weight loss data was stratified into placebo and orlistat groups. Potential for bias was assessed with a funnel plot and by calculating Kendall’s tau. The a priori alpha level was 0.05. RESULTS: Corresponding FDA reviews were located for 6 published orlistat trials. The pooled odds ratio of published vs. FDA 5%weight loss data for the placebo arm was 2.18 (95% CI: 1.83 to 2.60; p < 0.001) and 1.95 (95% CI: 1.70 to 2.24; p < 0.001) for the orlistat arm. The pooled odds ratio of published vs. FDA for 10% weight loss data for the placebo arm was 2.25 (95% CI: 1.74 to 2.91; p < 0.001) and 2.20 (95% CI: 1.88 to 2.57; p < 0.001) for the orlistat arm. The p-­‐values for Kendall’s tau for the 5% and 10% weight loss data were 0.054 and 0.34, respectively. CONCLUSIONS: Published orlistat trials presented 5% and 10% weight loss data that were twice of that reported in the FDA-­‐reviewed trials, and there was potential for bias in the 5% weight loss data.

Incluir a Coordena??o de Aperfei?oamento de Pessoal de N?vel Superior (CAPES) como ag?ncia financiadora. / Submitted by Jos? Henrique Henrique (jose.neves@ufvjm.edu.br) on 2017-12-20T20:56:06Z No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) rodrigo_gomes_oliveira.pdf: 944492 bytes, checksum: 3b83af9fb0686a20d237cd521e8852eb (MD5) / Approved for entry into archive by Rodrigo Martins Cruz (rodrigo.cruz@ufvjm.edu.br) on 2018-01-03T17:09:58Z (GMT) No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) rodrigo_gomes_oliveira.pdf: 944492 bytes, checksum: 3b83af9fb0686a20d237cd521e8852eb (MD5) / Made available in DSpace on 2018-01-03T17:09:58Z (GMT). No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) rodrigo_gomes_oliveira.pdf: 944492 bytes, checksum: 3b83af9fb0686a20d237cd521e8852eb (MD5) Previous issue date: 2017 / A pecu?ria exerce uma grande import?ncia nas exporta??es brasileiras. ? uma atividade econ?mica desenvolvida em ?reas rurais que consiste na cria??o de gado, caracterizada pela depend?ncia no uso de pastagens devido ao menor custo de produ??o. Com isso ? necess?rio uma grande ?rea de pastagens bem estruturada e com folhas e perfilhos de boa qualidade para suprir as exig?ncias do rebanho, tendo com isso uma boa lucratividade. Atualmente, uma das esp?cies forrageira que se encontra amplamente difundida no pa?s, ? a Urochloa brizantha (Syn. Brachiaria brizantha). Tal ocorr?ncia ? devida essa gram?nea, ter boa adapta??o a solos menos f?rteis, de textura arenosa e tolerar altas satura??es de alum?nio. Por?m, nas ?reas utilizadas para cultivo destas pastagens muitas se encontram com algum grau de degrada??o devido ? falta de manuten??o, em especial a falta de aduba??o e irriga??o. Propor tecnologias que auxiliem no desempenho dessas pastagens e proporcionem sua recupera??o torne-se essencial. Entre alternativas para diminuir a severidade desses problemas, o uso da irriga??o nos per?odos de veranicos pode ser uma t?cnica a ser usada, por?m existem regi?es no pa?s que a ?gua ? escassa e com isso essa t?cnica ? inv?lida. Outra op??o ? o uso de fertilizantes, por?m ? uma atividade de alto custo, com isso produtores procuram fertilizantes cada vez mais eficazes. O uso de fertilizantes organominerais vem se destacando, devido conter uma parte org?nica na sua formula??o e esta por sua vez, faz com que a libera??o dos nutrientes seja de forma mais lenta, promovendo menores perdas, al?m de auxiliar na reten??o de ?gua no solo. / Disserta??o (Mestrado) ? Programa de P?s-Gradua??o em Produ??o Vegetal, Universidade Federal dos Vales do Jequitinhonha e Mucuri, 2017. / Livestock farming is of great importance in brazilian exports. It is an economic activity developed in rural areas that consists of the cattle raising, characterized by the dependence on the use of pastures due to the lower cost of production. This requires a large, well-structured pasture area with good quality leaves and tillers to meet the requirements of the herd, thus making a good profitability. Currently, one of the forage species that is widely distributed in the country, is Urochloa brizantha (Syn. Brachiaria brizantha). Such occurrence is due to this grass, to have good adaptation to less fertile soils, of sandy texture and to tolerate high saturations of aluminum. However, in the areas used for cultivation of these pastures many are found to have some degree of degradation due to lack of maintenance, especially the lack of fertilization and irrigation. Proposing technologies that aid in the performance of these pastures and make their recovery become essential. Among alternatives to reduce the severity of these problems, the use of irrigation in summer periods may be a technique to be used, however there are regions in the country that water is scarce and thus this technique is invalid. Another option is the use of fertilizers, but it is a high-cost activity, with producers seeking more and more effective fertilizers. The use of organomineral fertilizers has been highlighted, due to the fact that it contains an organic part in its formulation and this, in turn, causes the release of nutrients to be slower, promoting lower losses, besides helping to retain water in the soil.

Given the recent concern from multiple healthcare stakeholders that the pipeline of medical innovation is slowing, this thesis provides insights on how to spur breakthrough medical innovation in present day. The findings and recommendations are derived from one of the largest collections of interview transcripts from biomedical innovators (n=143) responsible for developing critical devices, drugs and diagnostics used in medicine today. An exemplary case (coronary artery stent) was selected for an in-depth analysis, which included a detailed recounting of stent development and an exhaustive analysis of the patent literature. External factors either catalyzed (e.g., supportive institutions, strong underlying science and collaboration) or hindered (e.g., technology transfer challenges, lack of funding and onerous conflict of interest rules) the development process. Strategies aimed towards promoting transformative medical innovation should focus on institutional-level policies targeting early stages of innovation. This includes providing individuals with unique expertise with the capacity to pursue innovative work. Technology transfer processes should be simplified to enable collaboration for individuals between institutions with disparate expertise. Policymakers should continue to support basic science research, which underlies future innovations. In contrast, policies that increase reimbursement or reduce taxes for industry or extend patent terms are less likely to impact transformative innovation.

acase@tulane.edu / 1 / Shelly L Harris

The purpose of this research was to determine if bacteriophage (phage) could be used to treat and reduce the incidence of Listeria in food manufacturing facilities, and thereby reduce the risk of food products being cross-contaminated with Listeria monocytogenes. Listeria incidence in food manufacturing ready-to-eat environments was surveyed at 31 ready-to-eat (RTE) food plants. A total 4,829 samples were collected from all locations. Nine (29%) facilities had zero samples positive for Listeria spp., whereas 22 (71%) had one or more samples positive. The total incidence of Listeria spp. in all RTE food plants was 4.5%. The effectiveness of phage against Listeria was determined when applied to stainless steel, polyurethane thermoplastic, and epoxy. Each material was inoculated with a cocktail containing L. monocytogenes and L. innocua (4 to 5-log10 CFU/cm2) and treated with two different concentrations of phage (2x10^7 and 1x10^8 PFU/cm2). Treated samples were held at 4 or 20°C for 1 and 3h. After treatment with phage, Listeria reductions ranged from 1.27–3.33 log10 CFU/cm2 on stainless steel, 1.17–2.76 log10 CFU/cm2 on polyurethane thermoplastic, and 1.19–1.76 log10 CFU/cm2 on epoxy. Listeria reduction occurred on all materials tested, under all conditions. Higher phage concentration, longer time, and higher environmental temperatures led to significantly (P<0.05) greater reduction of Listeria on stainless-steel and polyurethane thermoplastic. The effectiveness of a phage against Listeria spp. was evaluated in two food manufacturing facilities, operating at either 4°C or 20°C. First, a moderate application of a 2x10^7 PFU/mL phage was applied once per day over three days and samples were collected and analyzed for Listeria at 0, 24, 48 and 72 h. This phage treatment led to a decrease in the incidence of Listeria by 67%. A second application method was studied with phage being applied in the food manufacturing environment in an intensified manner (3 times in 18 hours) at a higher concentration of phage (1x10^8 pfu/mL). This intensified application led to a 32% overall reduction in the incidence of Listeria in the production environment. Applications of Listeria specific phage can be an additional intervention strategy for controlling pathogenic Listeria organisms in food production facilities. / Doctor of Philosophy / Listeriosis is a serious illness caused by the bacterium Listeria monocytogenes. Annually in the United States it is estimated that 95.7% of all listeriosis illnesses are caused by the consumption of contaminated food, and it is generally recognized that L. monocytogenes is caused by cross contamination of ready-to-eat foods from an environmental source. The purpose of this research was to determine if food manufacturing facilities could use bacteriophage (phage) to treat and reduce the incidence of Listeria in food manufacturing plant, and thereby reduce the risk of food products being cross-contaminated with L. monocytogenes. The incident rate of Listeria was surveyed by collecting 4,829 samples from 31 ready-to-eat (RTE) food plants across the United States. Nine (29%) facilities had zero samples positive for Listeria spp., whereas 22 (71%) plants had one or more samples positive. The total incidence of Listeria spp. in all RTE food plant samples was 4.5%. Second, research was completed to determine if phage at different levels reduced Listeria on three common food manufacturing plant materials (stainless steel, polyurethane belting and epoxy flooring). After Listeria was attached to each material (4 to 5-log10 CFU/cm2), they were treated with two different levels of phage (2x10^7 and 1x10^8 PFU/cm2) at two temperatures (4 or 20°C) for 1 and 3 hours. After treatment with phage, Listeria reduction of 93.2 to 99.9% occurred on all materials tested, under all conditions. Finally, two different methods of applying phage (moderate and intensified) in a food manufacturing plant was studied. The moderate application was a single treatment with lower concentration of phage (2x10^7 PFU/mL) once per day for three days, while the intensified treatment was the application of high phage concentrations (1x10^8 pfu/mL) three different times, all in a single day. Both application methods reduced the incidence of Listeria in the food manufacturing plant. The total reduction across all trials was 67% using the moderate application method and 32% using the intensified application of phage.

Aproximadamente apenas um terço dos medicamentos utilizados em crianças tem sido estudado de forma adequada e apresentam informações sobre eficácia e segurança do produto. Este fato se deve a dificuldade de realização de ensaios clínicos na população pediátrica tornando-a mais propensa a erros de medicação, predominantemente devido à necessidade de prescrições de apresentações farmacêuticas não aprovadas e não indicadas para uso pela indústria e agência de fiscalização sanitária. Dessa forma, uma ferramenta importante que pode ser utilizada para análise do uso de medicamentos nesta população compreende os estudos da utilização de medicamentos. O presente estudo analisou as prescrições medicamentosas realizadas para crianças hospitalizadas no Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo, com a finalidade de estabelecer o perfil de utilização de medicamentos de acordo com os critérios de aprovação e indicação da Agencia Nacional de Vigilância Sanitária (ANVISA) e da Food and Drugs Administration (FDA). O estudo foi aprovado pelo Comitê de Ética em Pesquisa do respectivo hospital, e classificado como transversal, retrospectivo e observacional. Através do banco de dados informatizado, foram analisadas todas as prescrições medicamentosas a crianças menores de 12 anos no período compreendido entre 01/08/2008 a 31/07/2009. A população pediátrica foi dividida em subgrupos de acordo com os parâmetros fisiológicos do desenvolvimento estabelecidos pela Organização Mundial de Saúde. As apresentações farmacêuticas foram classificadas de acordo com o primeiro nível do sistema Anatomical Therapeutic Chemistry e, por conseguinte, foi realizada a classificação de uso das mesmas em: licenciado, não licenciado - registro, indicado, não indicado, não licenciado - dispersão e licenciado/indicado de acordo com a ANVISA e FDA. Durante o período analisado, foram identificados 6948 pacientes, 56,7% do sexo masculino, média de idade 3,1 (±3,5) anos, média de internação 17,5 (±29,8) dias, 1120 causas de internação e 79 unidades de atendimento. A causa de internação mais frequente esteve relacionada ao nascimento no hospital, sendo dessa forma, o centro obstétrico a unidade mais requisitada para hospitalização. Das 617 apresentações farmacêuticas identificadas, 17,6% foram referentes aos agentes infecciosos de uso sistêmico. A média de apresentações farmacêuticas por paciente foi de 6,1. Em relação ao uso não licenciado - registro 1,1% e 14,9% das apresentações farmacêuticas assim foram classificadas de acordo com a análise da ANVISA e FDA, respectivamente. O uso não indicado esteve presente em 36,5% e 37,3% de acordo com a ANVISA e FDA, respectivamente. Dessa forma, este trabalho ressalta a necessidade em se estabelecer um consenso sobre a classificação de uso dos medicamentos na população pediátrica entre os países, além de enfatizar a necessidade de aumentar a realização ensaios clínicos nesta população, uma vez que houve um elevado número de apresentações farmacêuticas com informações de uso apenas na população adulta sendo utilizadas em crianças / Approximately only one-third of the drugs used in children has been studied adequately and presents information about its effectiveness and safety. This fact is due to the difficulty of conducting clinical trials in the pediatric population making them more prone to medication errors, mainly due to the need for pharmaceutical dosage forms unapproved and off-label for use by industry and regulatory agency. Thus, an important tool that can be used to analyze the use of drugs in this population comprises studies of drug utilization. This study analyzed drug prescriptions for children hospitalized at the Clinical Hospital of the Faculty of Medicine of Ribeirão Preto - University of São Paulo, in order to establish the profile of drug utilization in accordance to the criteria for approval and indication of the Brazilian Regulatory Agency (ANVISA) and the Food and Drugs Administration (FDA). The study was approved by the Research Ethics Committee of the respective hospital, being classified as cross-sectional, retrospective, observational study. Through the computerized database, all drug prescriptions to children under the age of 12 were analyzed in the period of August 1st, 2008 to July 31st, 2009. The pediatric population was divided into subgroups according to the physiological parameters of development established by the World Health Organization. The pharmaceutical dosage forms were classified according to the first level of the Anatomical Therapeutic Chemistry system. Thereafter, the use of pharmaceutical dosage forms was classified as follows: licensed, unlicensed - registered, label, off-label, unlicensed - dispersion and licensed/label according to FDA and ANVISA. During the study period, 6948 patients were identified, being 56.7% male, mean age 3.1 (± 3.5) years, mean length of hospitalization 17.5 (± 29.8) days, 1120 causes of hospitalization and 79 service units. The most prevalent cause of hospital stays was related to birth at the hospital, being the obstetric center the most required unit for hospitalization. Of the 617 pharmaceutical dosage forms identified, 17.6% were related to infectious agents for systemic use. The average pharmaceutical dosage forms per patient were 6.1. Regarding the unlicensed use, 1.1% and 14.9% of the pharmaceutical dosage forms were classified according to the analysis from ANVISA and FDA, respectively. The off-label use was present in 36.5% and 37.3% according to ANVISA and FDA, respectively. This work emphasizes the need to establish a consensus on the classification of the use of drugs in the pediatric population among countries, and underline the necessity of increase the number of clinical trials performed in this population, since there were a high number of pharmaceutical dosage forms with use information only for adult populations being used in children.

Aproximadamente apenas um terço dos medicamentos utilizados em crianças tem sido estudado de forma adequada e apresentam informações sobre eficácia e segurança do produto. Este fato se deve a dificuldade de realização de ensaios clínicos na população pediátrica tornando-a mais propensa a erros de medicação, predominantemente devido à necessidade de prescrições de apresentações farmacêuticas não aprovadas e não indicadas para uso pela indústria e agência de fiscalização sanitária. Dessa forma, uma ferramenta importante que pode ser utilizada para análise do uso de medicamentos nesta população compreende os estudos da utilização de medicamentos. O presente estudo analisou as prescrições medicamentosas realizadas para crianças hospitalizadas no Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo, com a finalidade de estabelecer o perfil de utilização de medicamentos de acordo com os critérios de aprovação e indicação da Agencia Nacional de Vigilância Sanitária (ANVISA) e da Food and Drugs Administration (FDA). O estudo foi aprovado pelo Comitê de Ética em Pesquisa do respectivo hospital, e classificado como transversal, retrospectivo e observacional. Através do banco de dados informatizado, foram analisadas todas as prescrições medicamentosas a crianças menores de 12 anos no período compreendido entre 01/08/2008 a 31/07/2009. A população pediátrica foi dividida em subgrupos de acordo com os parâmetros fisiológicos do desenvolvimento estabelecidos pela Organização Mundial de Saúde. As apresentações farmacêuticas foram classificadas de acordo com o primeiro nível do sistema Anatomical Therapeutic Chemistry e, por conseguinte, foi realizada a classificação de uso das mesmas em: licenciado, não licenciado - registro, indicado, não indicado, não licenciado - dispersão e licenciado/indicado de acordo com a ANVISA e FDA. Durante o período analisado, foram identificados 6948 pacientes, 56,7% do sexo masculino, média de idade 3,1 (±3,5) anos, média de internação 17,5 (±29,8) dias, 1120 causas de internação e 79 unidades de atendimento. A causa de internação mais frequente esteve relacionada ao nascimento no hospital, sendo dessa forma, o centro obstétrico a unidade mais requisitada para hospitalização. Das 617 apresentações farmacêuticas identificadas, 17,6% foram referentes aos agentes infecciosos de uso sistêmico. A média de apresentações farmacêuticas por paciente foi de 6,1. Em relação ao uso não licenciado - registro 1,1% e 14,9% das apresentações farmacêuticas assim foram classificadas de acordo com a análise da ANVISA e FDA, respectivamente. O uso não indicado esteve presente em 36,5% e 37,3% de acordo com a ANVISA e FDA, respectivamente. Dessa forma, este trabalho ressalta a necessidade em se estabelecer um consenso sobre a classificação de uso dos medicamentos na população pediátrica entre os países, além de enfatizar a necessidade de aumentar a realização ensaios clínicos nesta população, uma vez que houve um elevado número de apresentações farmacêuticas com informações de uso apenas na população adulta sendo utilizadas em crianças / Approximately only one-third of the drugs used in children has been studied adequately and presents information about its effectiveness and safety. This fact is due to the difficulty of conducting clinical trials in the pediatric population making them more prone to medication errors, mainly due to the need for pharmaceutical dosage forms unapproved and off-label for use by industry and regulatory agency. Thus, an important tool that can be used to analyze the use of drugs in this population comprises studies of drug utilization. This study analyzed drug prescriptions for children hospitalized at the Clinical Hospital of the Faculty of Medicine of Ribeirão Preto - University of São Paulo, in order to establish the profile of drug utilization in accordance to the criteria for approval and indication of the Brazilian Regulatory Agency (ANVISA) and the Food and Drugs Administration (FDA). The study was approved by the Research Ethics Committee of the respective hospital, being classified as cross-sectional, retrospective, observational study. Through the computerized database, all drug prescriptions to children under the age of 12 were analyzed in the period of August 1st, 2008 to July 31st, 2009. The pediatric population was divided into subgroups according to the physiological parameters of development established by the World Health Organization. The pharmaceutical dosage forms were classified according to the first level of the Anatomical Therapeutic Chemistry system. Thereafter, the use of pharmaceutical dosage forms was classified as follows: licensed, unlicensed - registered, label, off-label, unlicensed - dispersion and licensed/label according to FDA and ANVISA. During the study period, 6948 patients were identified, being 56.7% male, mean age 3.1 (± 3.5) years, mean length of hospitalization 17.5 (± 29.8) days, 1120 causes of hospitalization and 79 service units. The most prevalent cause of hospital stays was related to birth at the hospital, being the obstetric center the most required unit for hospitalization. Of the 617 pharmaceutical dosage forms identified, 17.6% were related to infectious agents for systemic use. The average pharmaceutical dosage forms per patient were 6.1. Regarding the unlicensed use, 1.1% and 14.9% of the pharmaceutical dosage forms were classified according to the analysis from ANVISA and FDA, respectively. The off-label use was present in 36.5% and 37.3% according to ANVISA and FDA, respectively. This work emphasizes the need to establish a consensus on the classification of the use of drugs in the pediatric population among countries, and underline the necessity of increase the number of clinical trials performed in this population, since there were a high number of pharmaceutical dosage forms with use information only for adult populations being used in children.

Made available in DSpace on 2016-03-15T14:17:06Z (GMT). No. of bitstreams: 2 3.pdf: 1873007 bytes, checksum: 8eae9ab2248d143593f9cbc784373efc (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2014 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos/Farmanguinhos. Rio de Janeiro, RJ, Brasil. / As vacinas são produtos imunobiológicos reconhecidamente seguros, eficazes e com grande participação no controle e/ou erradicação de doenças imunopreveníveis, comprovando uma grande relação custo-benefício. Atualmente, Bio-Manguinhos é o principal fornecedor de vacinas para o Ministério da Saúde e para suprir as demandas do Programa Nacional de Imunização utiliza como uma das estratégias de fornecimento, acordos de transferência de tecnologia com empresas mundiais, como a GlaxoSmithKline e a Sanofi Pasteur, com o objetivo de suprir demandas epidemiológicas brasileiras e adquirir desenvolvimento tecnológico para a instituição, o que caracteriza um processo inovador de grande relevância. Os produtos gerados através deste processo precisam ser submetidos a testes de Controle de Qualidade e pesquisa clínica para comprovar a qualidade e a confirmação terapêutica, através de metodologias analíticas e bioanalíticas (bioensaios) validadas. Este trabalho tem como objetivo avaliar a aplicabilidade da RDC 27 da ANVISA e analisar os demais documentos de validação de bioensaios preconizados pela OMS, FDA, USP e EMEA. Para isto, foi realizada uma análise desses documentos para a verificação de diferenças, semelhanças e aplicação. Um estudo de caso foi realizado através da validação do teste de neutralização por redução de placa de lise para sarampo em placas de 96 poços (MICRO-PRNT) que é considerado pela literatura o método mais sensível e específico para a qualificação e quantificação de anticorpos neutralizantes produzidos após a vacinação. Porém, A validação foi desenhada de maneira mais direcionada as características particulares da metodologia, utilizando parâmetros e critérios de aceitação pertinentes, e as diretrizes aplicáveis dos órgãos citados acima. A validação proposta neste estudo apresentou resultados satisfatórios onde todos os parâmetros estabelecidos foram validados. Pode-se concluir que a RDC 27 é direcionada a bioensaios com característica cromatográfica e que os documentos dos demais órgãos também não apresentam uma aplicabilidade total. Na realidade é necessário que a ANVISA elabore um guia ou legislação de validação de metodologia que atenda as particularidades dos bioensaios utilizados nas pesquisas clínicas de vacinas para comprovação de imunogenicidade. / Vaccines are immunobiological products and are known to be safe, effective and with great participation in the control and / or eradication of immunopreventable diseases, proving that is an excelent cost benefit relation. Currently, Bio-Manguinhos is the main provider of vaccines for the Ministry of Health and to meet the demands of the National Immunization Program and uses as a strategy of supply, technology transfer agreements with global companies such as GlaxoSmithKline and Sanofi Pasteur, aiming to meet brazilian epidemiological demands and acquire technological development for the institution, configuring an innovative process of great relevance. The products generated through this process need to undergo Quality Control testing and clinical research to demonstrate the quality and therapeutic effectiveness through analytical and bioanalytical methods (bioassays) validated. This study aims to evaluate the applicability of the RDC 27 ANVISA and analyze other documents validation of bioassays recommended by WHO, FDA, USP and EMEA. For this, an analysis of these documents for verification of differences, similarities and application was done. A case study was performed through validation by reduction neutralization test for lysis plate for measles in 96-well plates (MICRO-PRNT) which is considered by the literature the most sensitive and specific method for qualification and quantification of neutralizing antibodies produced after vaccination. However, validation was designed in a more direct way to particular characteristics of the methodology, using parameters and acceptance criteria that are relevant and also applicable directives of the organs mentioned above. The validation proposed in this study showed satisfactory results where all parameters set were validated. It can be concluded that the RDC 27 is directed to bioassays with chromatographic characteristics and also that the documents of the other organs did not show an overall applicability. In reality, it is necessary that ANVISA prepares a guide or legislation of methodology validation that meets the particularities of bioassays used in clinical research of vaccines to prove the immunogenicity and also be useful for other bioassays with biological targets.