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  • About
  • The Global ETD Search service is a free service for researchers to find electronic theses and dissertations. This service is provided by the Networked Digital Library of Theses and Dissertations.
    Our metadata is collected from universities around the world. If you manage a university/consortium/country archive and want to be added, details can be found on the NDLTD website.
241

Dialize gydomų pacientų gyvenimo kokybė / Hemodialysis Patients Quality of Life

Sinkevičiūtė, Aušra 31 July 2013 (has links)
Darbe atlikta teorinė gyvenimo kokybės sampratos ir lėtiniu inkstų nepakankamumu sergančių pacientų gyvenimo bruožų analizė.Iškelta hipotezė, kad dialize gydomi pacientai blogai vertina visas pagrindines gyvenimo kokybės sritis. Gyvenimo kokybės klausimynu ir interviu pokalbio metodais buvo atliktas tyrimas, kurio tikslas - ištirti dialize gydomų pacientų gyvenimo kokybę. Tyrimo duomenys apdoroti statistinių programų paketu SPSS Statistics 17.0, Microsoft Excel ir turinio (angl. content) analizės metodu. Tyrime dalyvavo 100 dialize gydomų pacientų, iš kurių 5 pacientai dalyvavo interviu pokalbyje. Empirinėje dalyje nagrinėjamas dialize gydomų pacientų pagrindinių gyvenimo sričių (fizinės sveikatos, psichologinės, socialinių santykių, aplinkos sričių) vertinimas ir gyvenimo kokybės ypatumai. / The work carried out in the theoretical concept of quality of life and chronic renal failure patients living traits analyzed.The hypothesis that dialysis patients bad the quality of life of all the key areas.The quality of life questionnaire and interview techniques interview was conducted with the aim - to investigate dialysis patients quality of life. The data processing of the statistical software package SPSS 17.0, Microsoft Excel, and text content analysis.The study included 100 dialysis patients, of which five patients participated in the interview conversation.In the empirical part of dialysis patients major life domains (physical health, psychological, social relationships, environment areas) Assessment of quality of life features.
242

Who's on stage? Performative disclosure in Hannah Arendt's account of political action

Tchir, Trevor Unknown Date
No description available.
243

Survey on nail discoloration and association with CD4 count among untreated HIV patients at Apin Centre, Nigeria

Ekeh, Peter Nnamdi January 2010 (has links)
<p>Eligibility for antiretroviral therapy (ART) in HIV-infected patients is defined either by a cluster of differentiation antigen 4 (CD4) count of less than 200cells/mm3 or clinical diagnosis of WHO stage III and IV. Therefore, the decision to start ART becomes difficult when CD4 cell count is not available. With limited laboratory infrastructure, the decision to start ART is usually made based on clinical symptoms leading to late commencement of ART. This calls for alternative criteria to see if nail discoloration (ND) correlates with low CD4 count among untreated HIV infected patients. This will serve as a complementary screening tool for identifying asymptomatic ARV naive HIV patients with a CD4 cell count of less than 200cells/mm3 which signifies&nbsp / severe immunosuppression. Study Design and Setting: This was a quantitative cross-sectional descriptive and analytical study involving adult ART na&iuml / ve HIV infected patients in WHO stage I and II. Systematic sampling was used to select the participants from all adult ART na&iuml / ve HIV infected patients attending APIN clinic, located at the Jos University Teaching Hospital (JUTH), Jos, Nigeria. Data Collection: Face-to-face interviews, physical examination and relevant laboratory investigations with selected participants were conducted using a questionnaire guide. Questions on socio-demographic characteristics, clinical data, general physical examinations including finger nail examination and photographing with subsequent laboratory investigations including CD4 count and western blot were employed. Data Analysis: Variables were categorized and data analyzed using descriptive statistics including the frequency, percentage frequency / mean and standard deviation of continuous variables. Association between CD4 count of &le / 200cells/mm3 and ND was tested using the chisquare test with an alpha level of 0.05. Prevalence of ND, sensitivity, specificity, positive predictive and negative predictive values and accuracy of the screening test of ND was calculated. Results: 394 patients had their fingernails photographed and assessed. It was shown that distal banded and grey nails were the common types of ND seen with a prevalence of 38%. There was an association between CD4 count &le / 200cells/mm3 and ND (p&lt / 0.0001). CD4 count &le / 200cells/mm3 was a risk factor for developing ND (RR=2.3[1.8-3.6]). The association has a sensitivity of 78%, specificity of 55%, positive predictive value of 50%, and negative predictive value of 80% and accuracy of test 63%. Conclusion: With a significant association (p&lt / 0.0001) and a sensitivity of 78%, ND can be a useful clinical indicator of immune dysfunction mediated by HIV among patients in WHO stage I or II. ND can either be a clinical sign or a symptom in HIV patients with a CD4 of &le / 200cells/mm3 as seen in the study as the specificity and sensitivity of ND compared favourably with other WHO stage III diagnosis. Recommendations: Nail discoloration should complement CD4 count as an additional staging sign to help identify patients likely to benefit from ART especially in resource-limited settings. Finally, all patients with grey or distal banded should be on co-trimoxaxole prophylaxis in line with WHO /national guideline on the use of co-trimoxaxole for all HIV positive patients with a CD4 cell count of &le / 350cells/mm3.</p>
244

Knowing me, knowing you : Mentalization abilities of children who use augmentative and alternative communication / Knowing me, knowing you : Mentaliseringsförmågor hos barn som använder sig av alternativ och kompletterande kommunikation

Sundqvist, Annette (Anett) January 2010 (has links)
The present thesis investigated several components important to the understanding of mentalization for children who use augmentative and alternative communication (AAC). The result of the thesis demonstrated that non-verbal mental age correlated significantly with mentalization tasks, and that the participants did not significantly differ compared to a nonverbal age-matched group of children without disabilities. Different expression of active participation, which is necessary to be able to display mentalization in dialogue, was observed in analysed interaction. The children’s social networks were limited and consisted of very few peers, thus limiting the possibilities of active participation. The number of peers in the children’s social networks correlated significantly with aspects of the children’s mentalization ability. Children who use AAC display their mentalization abilities independently in social interaction and through e-mail messages to peers. A wider construct that will have relevance to mentalization in ordinary situations is described encompassing several different abilities. The development of these abilities is dependent on the child’s capacity for adapting a cognitive flexibility when reflecting and theorizing on what is happening in a given situation. The development of mentalization is also dependent on a child’s close friendships, active participation in interaction, functional language ability, and varied social networks consisting of both peers and adults.
245

Det allra bästa stödet : En kvalitativ intervju- och vinjettstudie om socialtjänstens arbete med barn som upplevt våld i familjen utifrån socialarbetares beskrivningar / The Very Best Support : A qualitative interview and vignette study about social services work with children who have experienced violence within the family from descriptions by social workers

Andersson, Ros-Mari, Kolm, Matilda January 2014 (has links)
Studiens syfte var att undersöka hur socialarbetare inom socialtjänsten i en kommun beskriver sitt arbete med barn och föräldrar där barn upplevt våld inom familjen.  Frågeställningarna handlade om hur barn görs delaktiga i socialtjänstens arbete och vilket stöd barn och föräldrar erhåller. Fem socialarbetare intervjuades utifrån en tematiserad intervjuguide och vinjett. De teoretiska perspektiven som användes i analysen var systemteori och risk- och skyddsfaktorer.  Resultatet visade på att barn är delaktiga i socialtjänstens arbete genom att de ges information och erbjuds samtal utifrån barnets behov.  Det framkom även att det finns ett helhetstänk inom socialtjänsten då både barn och föräldrar erbjuds stöd i familjer där barn upplevt våld. Dessutom visade resultatet på att socialtjänsten kan hjälpa till att utveckla det sociala nätverket hos familjerna. / The aim of this thesis was to study how social workers in social services in a municipality describe their work with children and parents in families where children have experienced violence within the family. The research questions concerned how children participate in social service work and what support children and parents receive. Five social workers were interviewed with a thematised interview guide and a vignette. The theoretical perspectives applied in the analysis were the systems theory and risk and protective factors. The results showed that children participate in social service work by being given information and support based on their needs. It also emerged that social services applied an overall policy of offering support to both children and parents in families where children have experienced violence. The results furthermore showed that social services can help families develop their social network.
246

Informacijos apie vaiko specialiuosius ugdymosi poreikius pateikimo ugdymo dalyviams ypatumai / The features of presenting information about child’s special education needs to education participants

Jankauskienė, Sonata 27 February 2014 (has links)
Darbe analizuojami informacijos apie vaiko specialiuosius ugdymosi poreikius pateikimo ugdymo dalyviams ypatumai. Interviu metodu buvo atliktas tyrimas, kurio tikslas - atskleisti informacijos apie vaiko specialiuosius ugdymosi poreikius pateikimo ugdymo dalyviams ypatumus. Tyrime dalyvavo 17 4 – 11 metų amžiaus vaikų, turinčių SUP; 16 tėvų, auginančių vaikus, turinčius SUP; 7 bendrojo ugdymo pedagogai, ugdantys vaikus, turinčius SUP; 6 pagalbos mokiniui specialistai. Empirinėje dalyje nagrinėjami ikimokyklinio ir mokyklinio amžiaus vaikų, turinčių SUP, jų tėvų, bendrojo ugdymo pedagogų, pagalbos mokiniui specialistų informacijos apie vaiko SUP pateikimo ypatumai. Svarbiausios empirinio tyrimo išvados: 1. Vaikams, turintiems SUP, dažniausiai nepateikiama informacija apie jų specialiuosius ugdymosi poreikius. Tai liudija nepakankamą mokinio įtraukimą į ugdymo procesą., Informaciją vaikui dažniau teikia pagalbos mokiniui specialistai (specialieji pedagogai, logopedai ir kt.). 2. Pateikiama informacija apie vaikų vidutinius, didelius ir labai didelius SUP labiau neigiamo pobūdžio, dominuoja informacija apie negalias, sutrikimus ir kt. 3. Informuojant apie vaikų SUP realizuojamos tokios nuostatos kaip pozityvumas, orientacija į ugdymosi procesą; nepakankamai realizuojamos tokios svarbios nuostatos kaip mokinio ir tėvų įtraukimas ir dalijimasis informacija, tėvų kompetencijos vertinimas, atsakomybės už vaiko ugdymą pasidalijimas, bendras problemos sprendimas. / This paper analyses the features of presenting information about child’s special educational needs to education participants. By the method of interviewing there was a study made with an aim to find out the features of presenting information about child’s special educational needs to education participants. In the study participated 17 children between the ages of 4 and 11 who have special educational needs; 16 parents of children with SEN; 7 pedagogues of general education who educate children with SEN; 6 specialists of pupil’s help. In the empirical part there is an investigation of features of how the information was given to pre – school and school children with SEN, their parents, pedagogues of general education, specialists of pupil’s help. The most important conclusions of empirical investigation: 1. The information about children’s special educational needs in most cases is not presented to them. It witnesses the insufficient child’s inclusion into the education process. The information is more frequently given to the child by specialists of pupil’s help. (Special pedagogues, speech – language pathologists, etc.) 2. Given information about children’s medium, big, or very big SEN is mostly negative, dominates information about disabilities, disorders, etc. 3. Such aspects as positiveness and orientation to education process are realized by informing about children’s SEN; such important aspects as involving child and his parents and sharing information, estimation of... [to full text]
247

Who's on stage? Performative disclosure in Hannah Arendt's account of political action

Tchir, Trevor 11 1900 (has links)
Hannah Arendt argues that political action is only meaningful through the disclosure of who the actor uniquely is, and that this disclosure is the basis of human dignity. Arendt’s notion of performative disclosure helps us to rethink the individuated actor, not as a sovereign and self-transparent subject whose action expresses an authentic individual essence or constative what, but rather as a decentered and ecstatic who whose action reveals meaningful dimensions of the world and of the actor’s unique situation in history, through the performance of acts and speech before public spectators. The idea that no actor can stand in a position of control with respect to his life story extends to a critical displacement of the notion of freedom understood as sovereignty and of political projects that attempt to make history. Action, as praxis and not poiesis, is best understood through Arendt’s metaphor of performance, rather than productive art. There are new interpretive possibilities for Arendt’s theory of action, especially if we trace appearances of the ancient Greek daimon in Arendt’s publications and lecture notes, and among works that Arendt confronted: Plato’s Socratic dialogues and the myth of Er, Heidegger’s notion of aletheia as Dasein’s disclosure of Being, Jaspers’ valid personality, and Kant’s notion of aesthetic genius. The daimon implies that the public realm is a spiritual realm, that action is a form of connection to the divine, and that the actor is a decentered discloser of transcendent meanings and new possibilities within the world. The daimon also shows moral deliberation to be more vital to meaningful action than Arendt suggests prior to The Life of the Mind, so that the distinctions usually read in Arendt between actor and spectator, as well as those between acting, thinking, and judging, may be productively occluded. Arendt’s struggle to re-invigorate action’s disclosive capacity is at the center of her entire project. It sheds light on her critique of the world-alienating aspects of Marx, her insistent protection of a distinct political sphere from the private and the social spheres, and her rejection of Hegel’s philosophy of history in favor of a fragmentary historiography inspired by Kafka and Benjamin.
248

Estudo epidemiológico das práticas sexuais desprotegidas em uma população de homens e travestis

Brignol, Sandra Mara Silva January 2008 (has links)
p. 1-216 / Submitted by Santiago Fabio (fabio.ssantiago@hotmail.com) on 2013-05-08T18:01:08Z No. of bitstreams: 4 ddddddddddddddw.pdf: 366263 bytes, checksum: 214248a4bc1b1481143085bf55270bb8 (MD5) cccccccccccc.pdf: 805194 bytes, checksum: 2d485e75e2131a0e5774158a2bb3ddb6 (MD5) bbbbbbbbbbbbb.pdf: 575446 bytes, checksum: 3bec72656f3a7823fe14ccc7a732eea9 (MD5) aaaaaaaa.pdf: 612916 bytes, checksum: c1acf4fcb837d2f43c5d65c4fe309d75 (MD5) / Approved for entry into archive by Rodrigo Meirelles(rodrigomei@ufba.br) on 2013-05-09T17:15:03Z (GMT) No. of bitstreams: 4 ddddddddddddddw.pdf: 366263 bytes, checksum: 214248a4bc1b1481143085bf55270bb8 (MD5) cccccccccccc.pdf: 805194 bytes, checksum: 2d485e75e2131a0e5774158a2bb3ddb6 (MD5) bbbbbbbbbbbbb.pdf: 575446 bytes, checksum: 3bec72656f3a7823fe14ccc7a732eea9 (MD5) aaaaaaaa.pdf: 612916 bytes, checksum: c1acf4fcb837d2f43c5d65c4fe309d75 (MD5) / Made available in DSpace on 2013-05-09T17:15:04Z (GMT). No. of bitstreams: 4 ddddddddddddddw.pdf: 366263 bytes, checksum: 214248a4bc1b1481143085bf55270bb8 (MD5) cccccccccccc.pdf: 805194 bytes, checksum: 2d485e75e2131a0e5774158a2bb3ddb6 (MD5) bbbbbbbbbbbbb.pdf: 575446 bytes, checksum: 3bec72656f3a7823fe14ccc7a732eea9 (MD5) aaaaaaaa.pdf: 612916 bytes, checksum: c1acf4fcb837d2f43c5d65c4fe309d75 (MD5) Previous issue date: 2008 / A prática do sexo oral e anal sem o uso do preservativo masculino é um importante fator para a infecção pelo HIV e outras DST na população dos homens que fazem sexo com homens (HSH) e das travestis. As relações entre características sociais, individuais, institucionais e as práticas sexuais desprotegidas são informações que podem ser utilizadas para estruturar ações de prevenção. Investigar as associações entre fatores de vulnerabilidade e as práticas sexuais desprotegidas além de descrever características dos HSH e travestis faz parte dos objetivos deste trabalho. O presente estudo é um recorte do Projeto Convida, inquérito sobre conhecimentos, atitudes, comportamentos e práticas de risco para a infecção pelo HIV entre HSH na cidade de Salvador na Bahia, em 2003. A população do estudo foi de HSH e travestis residentes na cidade de Salvador e região metropolitana que responderam ao questionário e que freqüentaram a “cena gay” desta cidade. A parte exploratória do estudo foi realizada com a análise de correspondência. Para a classificação da amostra em grupos, utilizou-se a análise de cluster. A modelagem estatística foi realizada utilizando regressão logística, todas norteadas pelo quadro conceitual da vulnerabilidade. A prática do sexo anal e oral desprotegido foi de 48,5% e 68,6% respectivamente, sendo a identidade sexual um importante fator para se descrever tais práticas nos grupos identificados na análise gráfica. Ajustou-se a formação dos grupos com a análise de cluster que permitiu identificar quais as características dos indivíduos que se envolvem mais freqüentemente na prática do sexo anal e oral desprotegido. A associação entre os diferentes grupos dos HSH e travestis e a prática do sexo anal desprotegido foi estatisticamente significante para o grupo dos que se sentem em médio risco de contrair HIV (OR=2,31; IC=1,68;3,19), os que se sentem em alto risco de contrair HIV (OR=1,56; IC95%=1,09;2,24), os que não responderam a percepção de risco (OR=3,20; IC95%=1,05;9,77), os ativos e passivos que gostam de todos os tipos de prática e parceria homossexual (OR=1,67 IC95%=1,07;2,61), os persuadidos/cuidadosos ao sexo desprotegido (OR=1,48; IC95%=1,16;1,89), os persuasivos e persuadidos a prática do sexo anal sem proteção (OR=6,75; IC95%=4,38;10,40). Para o sexo oral desprotegido, a associação foi estatisticamente significante para os grupos dos casados com mulher (OR=0,57; IC95%=0,38;0,87), os ativos e passivos que gostam de todos os tipos de prática e parceria homossexual (OR=3,65 IC95%=2,06;6,45), o ativo e passivo seletivo nos locais que freqüenta (OR=2,16; IC95%=1,25;3,73), o ativo sem preferência de parceiro (OR=2,34 ic95%=1,46;3,75 e os persuasivos e persuadidos a prática do sexo anal sem proteção (OR=2,41; IC95%=1,30;4,43). As práticas sexuais desprotegidas são freqüentes na população dos HSH e travestis da cidade de Salvador, sendo que os homossexuais parecem mais vulneráveis a estas práticas sexuais, seguidos das travestis. Os resultados são consistentes com alguns estudos que mostram a associação entre fatores da percepção de risco, prática do sexo insertivo sem proteção, negociação de regras para as práticas desprotegidas. Uma vantagem foi ter grupos de homens formados através da observação das relações simultâneas entre vários fatores para se observar as associações. A descrição detalhada das relações entre as práticas desprotegidas e características dos grupos de HSH e travestis podem ser usada para subsidiar ações diferenciadas e específicas de prevenção nos locais da “cena gay” de Salvador, convidando estes homens e travestis à práticas sexuais mais protegidas. / Salvador
249

A repercussão das diretrizes pedagógicas do SINASE no projeto arquitetônico de unidades socioeducativas de internação / The impact of the pedagogical guidelines of SINASE s document in the architectural of social-educational buildings

Souza, Danielle Gomes de Barros 31 March 2011 (has links)
Fundação de Amparo a Pesquisa do Estado de Alagoas / A diferenciação da forma de aprisionamento do jovem em conflito com a lei de uma pessoa adulta tem seus primeiros indícios com as casas de correção na Europa no século XVI. Desde então, tais espaços são modificados, adaptados e construídos ao longo dos séculos, sendo identificadas determinadas fases e isso se reflete no Brasil. Com a Constituição Federal de 1988 toda criança e adolescente passa a ser considerado sujeito de direito em qualquer situação, inclusive na privação de liberdade. Tal ponto é ratificado em 1990, com o Estatuto da Criança e do Adolescente, onde são adotadas as medidas socioeducativas para os jovens que cometem ato infracional, que tem cunho jurídico, mas principalmente ético e pedagógico. Apesar da mudança de paradigma, o Estatuto parece não se refletir na configuração dos espaços destinados aos jovens privados de liberdade, onde a estrutura física contribui para a situação desumana e degradante com que são tratados. É só com o documento Sistema Nacional de Atendimento Socioeducativo SINASE, que se estabelecem parâmetros arquitetônicos para a construção de unidades socioeducativas de internação. A partir daí parece existir uma mudança na configuração espacial dessas unidades, provavelmente pela exigência de seguir as orientações e parâmetros do documento para construção de unidades cujo financiamento é de origem federal. Diante dessa nova configuração e da exigência do documento para a construção de unidades socioeducativas, o objetivo desta dissertação é identificar a repercussão das diretrizes pedagógicas do SINASE nos projetos arquitetônicos de unidades socioeducativas de internação. Para tanto foi adotado como metodologia o estudo de casos múltiplos baseado na lógica da replicação, sendo escolhidas três unidades no Brasil e utilizados elementos da teoria da Sintaxe Espacial para a sua análise. O objetivo da utilização da Sintaxe foi trabalhar com a relação de segregação e integração dos espaços, considerando os espaços mais integrados os com maior potencial socioeducativo. Foram adotados como critérios o arranjo dos espaços e as barreiras e permeabilidades existentes em cada projeto, sendo possível constatar que as diretrizes do documento possibilitam a construção tanto de projetos mais socioeducativos como projetos que visam mais a disciplina como forma de controle. Conclui-se então que o documento do SINASE representa um grande avanço, mas é preciso que o projetista tenha conhecimento do real papel a ser desempenhado por uma unidade socioeducativa, para que possa inclusive questionar o programa estabelecido e as diretrizes contidas no documento que, em determinados pontos, são contraditórias e se contrapõem com a própria proposta socioeducativa.
250

Avaliação da aplicação e normas vigentes de validação de bioensaios para pesquisa clínica / Application Evaluation and current regulations bioassay validation for clinical research

Figueiredo, Ester Ribeiro de January 2014 (has links)
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.

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