Log in

Relevant bibliographies by topics / Bioequivalence / Dissertations / Theses

To see the other types of publications on this topic, follow the link: Bioequivalence.

Dissertations / Theses on the topic 'Bioequivalence'

Author: Grafiati

Published: 4 June 2021

Last updated: 25 July 2025

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Consult the top 50 dissertations / theses for your research on the topic 'Bioequivalence.'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Browse dissertations / theses on a wide variety of disciplines and organise your bibliography correctly.

1

Montague, Timothy H. "Adaptive designs for bioequivalence trails." Thesis, University of Reading, 2007. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.494779.

Full text

Abstract:

In recent years, there has been a growing interest within the medical research community in the application of adaptive designs in drug development. One potential application of adaptive designs is for bioequivalence trials, as they provide a means for managing the uncertainty around the anticipated variance to be used to power the study. If the anticipated variance is less than the true variance, the study may be under-powered resulting in the inability to demonstrate bioequivalence. Adaptive designs which allow one to both stop for success or futility at the interim or re-estimate the sample

APA, Harvard, Vancouver, ISO, and other styles

2

Purkiss, Ronald. "Bioequivalence of sustained release theophylline formulations." Thesis, Aston University, 1986. http://publications.aston.ac.uk/12472/.

Full text

Abstract:

The bioequivalence of sustained release theophylline formulations, marketed in the United Kingdom, has been investigated in relation to the co-administration of food in both single dose and steady state volunteer studies. The effect of food on pharmacokinetic parameters and their clinical relevance was researched. Experimentation using drug induced modification of gastric motility to ascertain the component influences of the rate of gastric emptying on the absorption of theophylline from sustained release formulations was conducted. Prolongation of time to maximum plasma theophylline concentra

APA, Harvard, Vancouver, ISO, and other styles

3

Bersbach, Brian. "Comparison of Levothyroxine Bioequivalence Between Products." The University of Arizona, 2006. http://hdl.handle.net/10150/624663.

Full text

Abstract:

Class of 2006 Abstract<br>Background: Approximately 2% of the population has hypothyroidism, and are treated with a levothyroxine product. Unlike other medications, levothyroxine products have not been considered substitutable due to their narrow therapeutic window. Objectives: To compare the bioequivalence study findings from studies conducted by the manufacturer of Synthroid to those conducted by other investigators. Methods: Studies comparing levothyroxine product bioequivalence were found and divided according to time period, study design, and major funding party. Results: Ten studies

APA, Harvard, Vancouver, ISO, and other styles

4

ALY, SAID. "Progres en bioequivalence et quelques problemes lies." Paris 6, 1990. http://www.theses.fr/1990PA066015.

Full text

Abstract:

La decision de bioequivalence entre deux (ou plusieurs) formulations d'un meme medicament, issues d'un meme fabriquant ou non, est devenue indispensable dans le domaine medical en pharmaceutique. Les definitions et les suppositions de bioequivalence ainsi que leur comprehension dans les essais comparatifs de biodisponibilite et les essais cliniques d'efficacite sont introduites dans le chapitre 1. La similarite des courbes de concentration jugee par comparaison des differentes procedures est le sujet principal du chapitre 2. Le resultat essentiel du chapitre 3 est la determination optimale des

APA, Harvard, Vancouver, ISO, and other styles

5

Dahman, Bassam. "NONLINEAR MODELS IN MULTIVARIATE POPULATION BIOEQUIVALENCE TESTING." VCU Scholars Compass, 2009. http://scholarscompass.vcu.edu/etd/1984.

Full text

Abstract:

In this dissertation a methodology is proposed for simultaneously evaluating the population bioequivalence (PBE) of a generic drug to a pre-licensed drug, or the bioequivalence of two formulations of a drug using multiple correlated pharmacokinetic metrics. The univariate criterion that is accepted by the food and drug administration (FDA) for testing population bioequivalence is generalized. Very few approaches for testing multivariate extensions of PBE have appeared in the literature. One method uses the trace of the covariance matrix as a measure of total variability, and another uses a po

APA, Harvard, Vancouver, ISO, and other styles

6

Patterson, Scott Daniel. "Statistical aspects of bioequivalence assessment in the pharmaceutical industry." Thesis, University College London (University of London), 2003. http://discovery.ucl.ac.uk/1383493/.

Full text

Abstract:

Since the early 1990's, average bioequivalence studies have served as the international standard for demonstrating that two formulations of drug product will provide the same therapeutic benefit and safety profile when used in the marketplace. Population (PBE) and Individual (IBE) bioequivalence have been the subject of intense international debate since methods for their assessment were proposed in the late 1980's. Guidance has been proposed by the Food and Drug Administration of the United States government for the implementation of these techniques in the pioneer and generic pharmaceutical

APA, Harvard, Vancouver, ISO, and other styles

7

Khin, Myo Oo Korbtham Sathirakul. "Bioequivalence study of pioglitazone tablets in Thai healthy volunteers /." Abstract, 2007. http://mulinet3.li.mahidol.ac.th/thesis/2550/cd401/4837398.pdf.

Full text

APA, Harvard, Vancouver, ISO, and other styles

8

Molins, Lleonart Eduard. "Proposing some innovative study design features to regulatory agencies (EMA and FDA) in bioequivalence trials : Reference Scaled Average Bioequivalence, and Two-Stage Adaptive Designs." Doctoral thesis, Universitat Politècnica de Catalunya, 2021. http://hdl.handle.net/10803/672170.

Full text

Abstract:

In applications for generic medicinal products the concept of bioequivalence is fundamental. Two medicinal products, i.e. a test and a reference drugs containing the same active substance are considered bioequivalent if their bioavailability (rate and extent of absorption of an active substance that is absorbed from a drug product and becomes available at the site of action) after the administration of both products produce a similar therapeutic effect. The assessment of bioequivalence is based upon 90% confidence intervals for the ratio of the population geometric means (test/reference) for t

APA, Harvard, Vancouver, ISO, and other styles

9

Demana, Patrick Hulisani. "Tropical corticosteroid bioequivalence testing comparison of chromameter and visual data." Thesis, Rhodes University, 1998. http://hdl.handle.net/10962/d1003233.

Full text

Abstract:

The major criticism of the human skin blanching assay is the subjective nature of grading the response. Recently the American FDA released a Guidance document for topical corticosteroid bioequi valence testing. The guidelines require the use of a chromameter as a reliable method to estimate skin blanching. The purpose of this study was to evaluate the recommendations of this document for appropriateness by comparing visual and chromameter data. The visually-assessed blanching assay methodology routinely practised in our laboratories was modified to comply with the specifications of the Guidanc

APA, Harvard, Vancouver, ISO, and other styles

10

Zha, Jiuhong. "Metrics evaluating bioavailability and bioequivalence, principles, and applications in the steady state." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 1999. http://www.collectionscanada.ca/obj/s4/f2/dsk1/tape9/PQDD_0004/NQ41354.pdf.

Full text

APA, Harvard, Vancouver, ISO, and other styles

11

Stippler, Erika [Verfasser]. "Biorelevant Dissolution Test Methods to Asses Bioequivalence of Drug Products / Erika Stippler." Aachen : Shaker, 2004. http://d-nb.info/1172616078/34.

Full text

APA, Harvard, Vancouver, ISO, and other styles

12

Rostami-Hodjegan, Amin. "Kinetics of metabolites : implications in the assessment of bioequivalence and enzyme activity." Thesis, University of Sheffield, 1996. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.245578.

Full text

APA, Harvard, Vancouver, ISO, and other styles

13

BUI, TUNG HIEP. "Etude de la stereoselectivite de la pharmacocinetique de la chlorpheniramine : influence sur les etudes de bioequivalence (doctorat : pharmacotechnie et biopharmacie)." Paris 11, 1999. http://www.theses.fr/1999PA114819.

Full text

APA, Harvard, Vancouver, ISO, and other styles

14

GAMERRE, DELPHINE. "Le medicament generique." Strasbourg 1, 1995. http://www.theses.fr/1995STR15113.

Full text

APA, Harvard, Vancouver, ISO, and other styles

15

Maluly, Hellen Dea Barros. "Estudo de bioequivalencia de duas formulações de cefadroxil - capsula (500mg) em voluntarios sadios de ambos os sexos." [s.n.], 2005. http://repositorio.unicamp.br/jspui/handle/REPOSIP/311845.

Full text

Abstract:

Orientador: Ronilson Agnaldo Moreno<br>Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Ciências Médicas<br>Made available in DSpace on 2018-08-05T05:47:22Z (GMT). No. of bitstreams: 1 Maluly_HellenDeaBarros_M.pdf: 7988282 bytes, checksum: 2d5724c0002bc95aaec9c7de5cbd35bd (MD5) Previous issue date: 2005<br>Resumo: O Objetivo deste estudo foi comparar a bioequivalência do Cefadroxil - cápsula (500mg) da Apotex do Brasil Ltda (formulação teste) and Cemmox@do Laboratório Bristol-Myers Squibb (formulação de referencia) em voluntários sadios de ambos os sexos. Este estudo

APA, Harvard, Vancouver, ISO, and other styles

16

Consiglieri, Vladi Olga. "Avaliação da qualidade biofarmacêutica da ampicilina sob as formas de suspensão e cápsulas: ensaios in vitro e in vivo (bioequivalência)." Universidade de São Paulo, 1996. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-24062008-084601/.

Full text

Abstract:

A avaliação biofarmacêutica de formas farmacêuticas contendo ampicilina foi realizada em dois lotes de cápsulas e dois de suspensão oral. O estudo da bioequivalência seguiu delineamento experimental cruzado, com dois períodos, empregando 16 voluntários de ambos os sexos (7 homens e 9 mulheres), com idades entre 21 e 26 anos (média de 23 anos) e peso entre 48 e 105 Kg (média de 68,2 Kg), dentro do intervalo de 10 % do peso ideal. Exames clínicos e laboratoriais foram realizados para selecionar os voluntários, sendo excluídos aqueles que apresentaram alguma alteração nos parâmetros clínicos norm

APA, Harvard, Vancouver, ISO, and other styles

17

Parfitt, Natalie Rae. "Investigations of the assessment of bioequivalence of topical clotrimazole products using a dermatopharmacokinetic approach." Thesis, Rhodes University, 2010. http://hdl.handle.net/10962/d1007659.

Full text

Abstract:

The specialised nature of the stratum corneum makes it an efficient barrier to foreign substances, including drug molecules. Therefore, cutaneous drug absorption is a slow and complex process of which stratum corneum penetration is the rate limiting step. The rate and extent of stratum corneum penetration by a drug compound depends greatly on the presence of penetration enhancing/retarding excipients and therefore the clinical outcomes of a product rely greatly on the components and quality of the formulation. Hence, establishing bioequivalence between topical products is crucial to ensure tha

APA, Harvard, Vancouver, ISO, and other styles

18

Ujamaa, Dawud A. "Assessing the Effect of Prior Distribution Assumption on the Variance Parameters in Evaluating Bioequivalence Trials." Digital Archive @ GSU, 2006. http://digitalarchive.gsu.edu/math_theses/13.

Full text

Abstract:

Bioequivalence determines if two drugs are alike. The three kinds of bioequivalence are Average, Population, and Individual Bioequivalence. These Bioequivalence criteria can be evaluated using aggregate and disaggregate methods. Considerable work assessing bioequivalence in a frequentist method exists, but the advantages of Bayesian methods for Bioequivalence have been recently explored. Variance parameters are essential to any of theses existing Bayesian Bioequivalence metrics. Usually, the prior distributions for model parameters use either informative priors or vague priors. The Bioeq

APA, Harvard, Vancouver, ISO, and other styles

19

Lauro-Marty, Claude. "Etudes pharmacocinétique et biopharmaceutique, chez l'homme sain, du 5-mononitrate d'isosorbide évalué par couplage chromatographie en phase gazeuse - spectrométrie de masse." Clermont-Ferrand 1, 1995. http://www.theses.fr/1995CLF1PP03.

Full text

APA, Harvard, Vancouver, ISO, and other styles

20

Taurelle, Valérie. "La terbinafine : pharmacocinétique de la molécule mère et d'un métabolite aprés administration orale unique d'un comprimé à 250 mg, étude de bioéquivalence entre quatre formes galéniques." Paris 5, 1992. http://www.theses.fr/1992PA05P212.

Full text

APA, Harvard, Vancouver, ISO, and other styles

21

Guzzo, Giovanni Carvalho. "Profile of adverse events in bioequivalence trials at the Clinical Pharmacology Unit since 2000 to 2003." Universidade Federal do CearÃ, 2004. http://www.teses.ufc.br/tde_busca/arquivo.php?codArquivo=146.

Full text

Abstract:

Conselho Nacional de Desenvolvimento CientÃfico e TecnolÃgico<br>The inexistence of medicines that act only in one target cell leads to a possible interaction at others cell structures which are not related to their therapeutic action, coming to the appearance of adverse drug reactions (ADR). The Pharmacovigillance System may lead to a better ADR analysis at a health or research institution, making itself essential for adverse events (AE) registering throughout clinical trials and more efficient investigation and notification afterwards. With the objective of evaluation of AE registered duri

APA, Harvard, Vancouver, ISO, and other styles

22

Haugel, Nathalie. "Etude de bioéquivalence de deux formulations galéniques, par voie orale, d'un anti-angoreux et de son principal métabolite." Paris 5, 1999. http://www.theses.fr/1999PA05P003.

Full text

APA, Harvard, Vancouver, ISO, and other styles

23

Taylor, Veronica Nell. "The use of three partial areas for establishing bioequivalence and estimation of sample size for equivalence studies /." Search for this dissertation online, 2003. http://wwwlib.umi.com/cr/ksu/main.

Full text

APA, Harvard, Vancouver, ISO, and other styles

24

Silva, Lara Cristina. "Quantificação do 5-mononitrato de isossorbida em plasma humano por cromatografia liquida de alta eficiencia acoplada a espectrometro de massa com fotoionização em pressão atmosferica." [s.n.], 2007. http://repositorio.unicamp.br/jspui/handle/REPOSIP/309494.

Full text

Abstract:

Orientador: Gilberto de Nucci<br>Tese (doutorado) - Universidade Estadual de Campinas, Faculdade de Ciencias Medicas<br>Made available in DSpace on 2018-08-09T23:19:38Z (GMT). No. of bitstreams: 1 Silva_LaraCristina_D.pdf: 3120798 bytes, checksum: acd2f9ee25770674d89f8546b794c073 (MD5) Previous issue date: 2007<br>Resumo: O 5-mononitrato de isossorbida (5-MNIS) é um nitrato orgânico comumente usado no tratamento da angina pectoris em razão de suas propriedades vasodilatadoras. No presente estudo, um novo método foi desenvolvido para determinar e quantificar o 5-MNIS no plasma humano por crom

APA, Harvard, Vancouver, ISO, and other styles

25

Campos, Daniel Rossi de. "Avaliação in vitro - in vivo de duas formulações de pantoprazol : estudos farmacocineticos e perfis de dissolução em meios biorelevantes." [s.n.], 2008. http://repositorio.unicamp.br/jspui/handle/REPOSIP/310120.

Full text

Abstract:

Orientador: Jose Pedrazzoli Junior<br>Tese (doutorado) - Universidade Estadual de Campinas, Faculdade de Ciencias Medicas<br>Made available in DSpace on 2018-08-12T09:45:13Z (GMT). No. of bitstreams: 1 Campos_DanielRosside_D.pdf: 1666073 bytes, checksum: 1437407c543022990155fc5709053ecc (MD5) Previous issue date: 2008<br>Resumo: O objetivo do presente estudo foi comparar o comportamento in vivo e in vitro de duas formulações de pantoprazol. Além disso, foi proposta a classificação biofarmacêutica provisional do fármaco, bem como uma correlação in vitro - in vivo não linear (IVIVR). Os estudo

APA, Harvard, Vancouver, ISO, and other styles

26

Esther, Sylvie. "Propriétés pharmacologiques et pharmacocinétiques de la terbinafine : étude de bioéquivalence de deux formulations orales." Paris 5, 1994. http://www.theses.fr/1994PA05P190.

Full text

APA, Harvard, Vancouver, ISO, and other styles

27

Porta, Valentina. "Avaliação da bioequivalência de formulações do mercado nacional contendo fluconazol." Universidade de São Paulo, 1999. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-11122006-170846/.

Full text

Abstract:

O fluconazol é um fármaco antifúngico utilizado na prevenção e tratamento de infecções micóticas. Atualmente, no mercado brasileiro, vários laboratórios farmacêuticos comercializam produtos a base de fluconazol na forma de cápsulas de 150 mg. Estes produtos são considerados similares e, portanto, teoricamente intercambiáveis, por conterem o mesmo princípio ativo nas mesmas dosagem e forma farmacêutica. No entanto, não existem estudos atestando a bioequivalência entre eles. Pretendeu-se, nesse trabalho, realizar avaliação biofarmacotécnica in vitro (cinética de dissolução) e in vivo (bioequival

APA, Harvard, Vancouver, ISO, and other styles

28

Deprez, Dominique. "Etude de bioéquivalence entre deux formulations de tenidap." Paris 5, 1993. http://www.theses.fr/1993PA05P078.

Full text

APA, Harvard, Vancouver, ISO, and other styles

29

Tettey-Amlalo, Ralph Nii Okai. "Application of dermal microdialysis and tape stripping methods to determine the bioavailability and/or bioequivalence of topical ketoprofen formulations." Thesis, Rhodes University, 2008. http://hdl.handle.net/10962/d1003274.

Full text

Abstract:

The widespread acceptance of topical formulations intended for local and/or regional activity has prompted renewed interest in developing a model to determine the bioavailability of drugs in order to establish bioequivalence as a means of evaluating formulation performance of multisource products and also for use during formulation development. Current in vivo techniques such as blister suction and skin biopsy amongst others used to determine the bioavailability and/or bioequivalence of topical formulations are either too invasive to generate appropriate concentration-time profiles or require

APA, Harvard, Vancouver, ISO, and other styles

30

Duquesnoy, Claire. "Application de différentes mesures indirectes de la vitesse d'absorption en utilisant les résultats d'études de bioéquivalence simulées et réelles." Paris 5, 1993. http://www.theses.fr/1993PA05P107.

Full text

APA, Harvard, Vancouver, ISO, and other styles

31

Kano, Eunice Kazue. "Avaliação de diferentes cronogramas de coletas de amostras biológicas em estudos de bioequivalência e análise da influência de teor de fármaco sobre os resultados destes estudos." Universidade de São Paulo, 2008. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-27052008-104740/.

Full text

Abstract:

Os estudos de bioequivalência são realizados em humanos, por meio da administração dos medicamentos em estudo pela mesma via extravascular, sob condições experimentais padronizadas, seguida pela determinação das concentrações plasmáticas do fármaco em função do tempo. Nestes estudos considera-se que curvas estatisticamente semelhantes de decaimento sanguíneo de fármacos produzem o mesmo resultado em termos de eficácia e segurança. A partir das curvas de concentração em função do tempo obtidas, determinam-se os parâmetros farmacocinéticos Cmax, tmax e ASC. A bioequivalência entre dois produtos

APA, Harvard, Vancouver, ISO, and other styles

32

Gabriels, Gary Anthony. "Determination of the effect of blood testing intervals on bioavailability and bioequivalence assessment of fixed-dose drug combination anti-tuberculosis drugs." Master's thesis, University of Cape Town, 2003. http://hdl.handle.net/11427/3387.

Full text

APA, Harvard, Vancouver, ISO, and other styles

33

Bueno, Marcia Martini. "Implantação, evolução, aspectos técnicos e perspectivas da regulamentação técnica de biodisponibilidade relativa e bioquivalência de medicamentos genéricos e similares no Brasil." Universidade de São Paulo, 2005. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-02022009-101019/.

Full text

Abstract:

A Política de Saúde no Brasil, que inclui a Política Nacional de Medicamentos, a criação da Agência Nacional de Vigilância Sanitária (ANVISA), a promulgação da Lei de Medicamentos Genéricos, bem como a publicação das Resoluções que estabelecem os critérios técnicos para seu registro, revolucionou o mercado farmacêutico brasileiro na última década, introduzindo vários conceitos como Equivalência Farmacêutica e Terapêutica, Biodisponibilidade e Bioequivalência. Tais conceitos constituem as bases científicas para a implantação dos medicamentos genéricos, aliados à certificação de Boas Práticas de

APA, Harvard, Vancouver, ISO, and other styles

34

Armando, Yara Popst. "Avaliação da bioequivalência entre comprimido convencional e comprimido de desintegração oral contendo 8 mg de ondansetrona." Universidade de São Paulo, 2008. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-08102009-190008/.

Full text

Abstract:

A ondansetrona (1,2,3,9-tetrahidro-9-metil-3-[(2-metil-1H-imidazol-1-il)metil]-4H-carbazol-ona) é o primeiro fármaco da classe dos antagonistas seletivos dos receptores de serotonina 5-HT3. É utilizada na prevenção de náusea e vômito induzidos por agentes quimioterápicos. O objetivo deste estudo foi avaliar a equivalência terapêutica através da análise da bioequivalência de dois produtos contendo 8 mg de ondansetrona, sendo um sob a forma de comprimidos de liberação convencional e outro sob a forma de comprimidos de desintegração oral, produzidos por laboratórios distintos. O ensaio de bioequi

APA, Harvard, Vancouver, ISO, and other styles

35

Brioschi, Tatiane Maria de Lima Souza. "Avaliação da bioequivalência de comprimidos contendo 10 mg de cloridrato de ciclobenzaprina." Universidade de São Paulo, 2006. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-13122006-091912/.

Full text

Abstract:

A ciclobenzaprina é um relaxante muscular de ação central estruturalmente similar aos antidepressivos tricíclicos. O objetivo deste trabalho foi avaliar a bioequivalência de comprimidos contendo 10 mg de cloridrato de ciclobenzaprina em voluntários sadios. O estudo de bioequivalência entre o produto teste (Miosan®) e referência (Flexeril®) foi do tipo randomizado, aberto e cruzado. Os produtos foram administrados por via oral aos voluntários em dose única de 10 mg de cloridrato de ciclobenzaprina. Amostras de sangue foram coletadas até 240 horas após a administração do fármaco e quantifica

APA, Harvard, Vancouver, ISO, and other styles

36

Lou, Yiyue. "Principal stratification : applications and extensions in clinical trials with intermediate variables." Diss., University of Iowa, 2017. https://ir.uiowa.edu/etd/5961.

Full text

Abstract:

Randomized clinical trials (RCTs) are considered to be the "gold standard" in order to demonstrate a causal relationship between a treatment and an outcome because complete randomization ensures that the only difference between the two units being compared is the treatment. The intention-to-treat (ITT) comparison has long been regarded as the preferred analytic approach for RCTs. However, if there exists an “intermediate” variable between the treatment and outcome, and the analysis conditions on this intermediate, randomization will break down, and the ITT approach does not account properly fo

APA, Harvard, Vancouver, ISO, and other styles

37

Au, Wai Ling. "Investigations of the bioavailability/bioequivalence of topical corticosteroid formulations containing clobetasol propionate using the human skin blanching assay, tape stripping and microdialysis." Thesis, Rhodes University, 2010. http://hdl.handle.net/10962/d1003221.

Full text

Abstract:

Currently, clinical trials in patients are required by most regulatory authorities for the assessment of bioequivalence of topical products where the drug is not intended for systemic absorption. Hence there is a dire need for suitable methods for the assessment of bioavailability and bioequivalence of such products since clinical safety and efficacy studies are expensive, time-consuming and require very large numbers of patients. Except for topical corticosteroid products where the human skin blanching assay/vasoconstrictor assay has been approved by the US FDA for bioequivalence assessment o

APA, Harvard, Vancouver, ISO, and other styles

38

Pioto, Ligia Rodrigues. "Estudo de biodisponibilidade relativa entre duas formulações de metotrexato em plasma humano utilizando cromatografia liquida acoplada a espetrometria de massas em serie." [s.n.], 2007. http://repositorio.unicamp.br/jspui/handle/REPOSIP/310085.

Full text

Abstract:

Orientador: Jose Luiz Donato<br>Tese (doutorado) - Universidade Estadual de Campinas, Faculdade de Ciencias Medicas<br>Made available in DSpace on 2018-08-10T07:16:04Z (GMT). No. of bitstreams: 1 Pioto_LigiaRodrigues_D.pdf: 680751 bytes, checksum: 6d472989ce55c9ad510ce3f7fffb6630 (MD5) Previous issue date: 2007<br>Resumo: Foi desenvolvido um métdo rápido, sensível e específico para determinação de metotrexato em plasma sanguíneo humano por cromatografia líquida acoplada a espectrometria de massas em série usando folinato de cálcio como padrão interno. O metotrexato foi extraído do plasma hum

APA, Harvard, Vancouver, ISO, and other styles

39

Silva, Renato Medeiros. "Biodisponibilidade comparativa de duas formulações de losartan em voluntarios humanos sadios apos administração de dose unica." [s.n.], 2009. http://repositorio.unicamp.br/jspui/handle/REPOSIP/309465.

Full text

Abstract:

Orientador: Gilberto de Nucci<br>Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Ciencias Medicas<br>Made available in DSpace on 2018-08-14T20:52:52Z (GMT). No. of bitstreams: 1 Silva_RenatoMedeiros_M.pdf: 5432076 bytes, checksum: abb10d1ceb928cd0c634eae336f2d154 (MD5) Previous issue date: 2009<br>Resumo: Esta dissertação irá focar na avaliação da bioequivalência de duas formulações do Losartan Potássico (50mg) comprimidos de liberação imediata (Losartan do Laboratório Cristália Ltda, Brasil, como formulação teste e Cozaar® da Merck Sharp & Dohme Farmacêutica Brasil

APA, Harvard, Vancouver, ISO, and other styles

40

Moreira, Roberto Fernandes 1979. "Determinação do perfil farmacocinético de fármacos com ação anti-hipertensiva aplicados à clínica." [s.n.], 2011. http://repositorio.unicamp.br/jspui/handle/REPOSIP/311496.

Full text

Abstract:

Orientador: Ney Carter do Carmo Borges<br>Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Ciências Médicas<br>Made available in DSpace on 2018-08-18T16:31:42Z (GMT). No. of bitstreams: 1 Moreira_RobertoFernandes_M.pdf: 9049271 bytes, checksum: da0d5e2ef677c3ea82ea931de845e3f8 (MD5) Previous issue date: 2011<br>Resumo: O presente trabalho avaliou o perfil farmacocinético de dois medicamentos anti-hipertensivos, contendo associação de losartana 100 mg + hidroclorotiazida 25 mg na forma farmacêutica de comprimidos revestidos. Foi utilizado um método bioanalítico, apropr

APA, Harvard, Vancouver, ISO, and other styles

41

Silva, Marina de Freitas. "Determinação da bioequivalência do metronidazol a partir de comprimidos revestidos." Universidade de São Paulo, 2009. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-16112009-181138/.

Full text

Abstract:

O metronidazol é usado no tratamento de infecções causadas por protozoários e naquelas causadas por microrganismos anaeróbicos, no tratamento das formas intestinais e extra-intestinais de amebíase, em tricomoníase e em infecções bacterianas aeróbicas graves. Após administração oral, a absorção é rápida e completa sendo amplamente distribuído, atinge concentração plasmática máxima em 1-2 horas. A meia-vida de eliminação do metronidazol é de 6-12 horas. O objetivo deste trabalho foi avaliar a equivalência terapêutica por meio da bioequivalêmcia entre duas formulações de comprimidos revestidos co

APA, Harvard, Vancouver, ISO, and other styles

42

Serra, Cristina Helena dos Reis. "Avaliação biofarmacotécnica de comprimidos contendo cefalexina: cinética de dissolução e bioequivalência." Universidade de São Paulo, 1998. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-23062008-165853/.

Full text

Abstract:

A cefalexina é um antibiótico semi-sintético, derivado das cefalosporinas, que exibe amplo espectro de ação, sendo largamente empregado por via oral. No Brasil é comercializado na forma de comprimido revestido, por cinco laboratórios farmacêuticos diferentes. No presente estudo foram avaliados, do ponto de vista biofarmacotécnico, 2 especialidades farmacêuticas (A e B), sob a forma de comprimidos revestidos, contendo 500 mg de cefalexina, disponíveis no mercado nacional. A análise in vitro foi realizada para dois lotes (1 e 2) de cada produto (A e B), através de ensaios físicos e físico-químic

APA, Harvard, Vancouver, ISO, and other styles

43

Faessel, Hélène. "Analyse de la pharmacocinétique du SDZ HTF 919 par modélisation après administrations intraveineuse et orale à des sujets sains : étude de bioéquivalence." Paris 5, 1994. http://www.theses.fr/1994PA05P149.

Full text

APA, Harvard, Vancouver, ISO, and other styles

44

Ngeacharernkul, Pratak. "Particle size distribution (PSD) equivalency using novel statistical comparators and PBPK input models." Diss., University of Iowa, 2017. https://ir.uiowa.edu/etd/5973.

Full text

Abstract:

For disperse system drug formulations, meaningful particle size distribution (PSD) comparators are essential in determining pharmaceutical equivalency and predicting biopharmaceutical equivalence in terms of the effect of particle size on the rate and extent of drug input. In formulation development and licensure, particle size characterization has been applied to establish relationships for bioequivalence of generic pharmaceutical drug products. The current approaches recommended by the US-FDA using median and span are not adequate to predict drug product performances or account for multi-mod

APA, Harvard, Vancouver, ISO, and other styles

45

Sverdloff, Carlos Eduardo. "Estudo de farmacocinetica comparativa de uma formulação de amlodipina + maleato de enalapril versus uma formulação de amlodipina e versus uma formulação de maleato de enalapril em voluntarios sadios de ambos os sexos." [s.n.], 2009. http://repositorio.unicamp.br/jspui/handle/REPOSIP/309466.

Full text

Abstract:

Orientador: Gilberto de Nucci<br>Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Ciencias Medicas<br>Made available in DSpace on 2018-08-15T13:17:16Z (GMT). No. of bitstreams: 1 Sverdloff_CarlosEduardo_M.pdf: 4673925 bytes, checksum: f893198475aafb4eeacafebdb4936962 (MD5) Previous issue date: 2009<br>Resumo: Introdução: Com base em evidências de estudos mostrando que em cerca de 2/3 dos casos de hipertensão a monoterapia não é suficiente para atingir as reduções pressóricos previstas, e diante da necessidade de controle mais rigoroso dos níveis pressóricos, há clara

APA, Harvard, Vancouver, ISO, and other styles

46

Marcolongo, Raquel. "Dissolução de medicamentos: fundamentos, aplicações, aspectos regulatórios e perspectivas na área farmacêutica." Universidade de São Paulo, 2003. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-19012004-204832/.

Full text

Abstract:

O teste de dissolução é uma ferramenta muito importante na indústria farmacêutica, tanto no desenvolvimento de produtos quanto no controle de qualidade de rotina. Apesar de ter sido inicialmente desenvolvido para formas farmacêuticas sólidas, nos últimos anos o teste de dissolução vem sendo aplicado também a formas não sólidas, como suspensões, adesivos transdérmicos, supositórios e outras. Recentemente, com a discussão em torno dos medicamentos genéricos outros empregos do ensaio de dissolução tornaram-se importantes. A comparação de perfis de dissolução, por exemplo, é fundamental para evit

APA, Harvard, Vancouver, ISO, and other styles

47

Leite, Diana Filipa Gomes. "Curricular training at a phase I clinical trials unit." Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/13278.

Full text

Abstract:

Mestrado em Biomedicina Farmacêutica<br>This report describes a curricular training in a Phase I Clinical Trials Unit, Blueclinical Ltd, company with different business areas in clinical research. Regarding clinical research, an overview of the traditional and the new paradigm of pharmaceutical development is present as well Phase I and Bioequivalence clinical trials details, the European and Portuguese regulatory environment. During the training, I participated in nine clinical trial submissions to Portuguese Competent Authorities. I also participated in the conduction of five bioequivalenc

APA, Harvard, Vancouver, ISO, and other styles

48

Tzou, Jia-Shyang, and 鄒嘉祥. "Statistical Evaluation of Individual Bioequivalence." Thesis, 1998. http://ndltd.ncl.edu.tw/handle/94916028848992819089.

Full text

Abstract:

碩士<br>國立成功大學<br>統計學系<br>86<br>The concept of the bioequivalence is illustrated in terms of prescribabilityfor population bioequivalence (PBE) and switchability for individual bioequival- ence (IBE). Since the bioequivalence is the assurance of the efficacy and safetyof a drug, the U.S. Food and Drug Administration (FDA) set a series of rules tojudge whether the test and reference formulation are therapeutical equivalent ornot. In the past, the U.S. FDA published so-called "1992 guidance" th

APA, Harvard, Vancouver, ISO, and other styles

49

Nyathi, Mavuto. "Statistical analysis of bioequivalence studies." Thesis, 2016. http://hdl.handle.net/10539/21660.

Full text

Abstract:

A Research Report submitted to the Faculty of Science in partial fulfilment of the requirements for the degree of Master of Science. 26 October 2016.<br>The cost of healthcare has become generally expensive the world over, of which the greater part of the money is spent buying drugs. In order to reduce the cost of drugs, drug manufacturers came up with the idea of manufacturing generic drugs, which cost less as compared to brand name drugs. The challenge which arose was how safe, effective and efficient the generic drugs are compared to the brand name drugs, if people were to buy them. As a c

APA, Harvard, Vancouver, ISO, and other styles

50

Silva, Nuno Miguel Elvas Neves 1974. "Modelling and simulation in bioequivalence." Doctoral thesis, 2012. http://hdl.handle.net/10451/6596.

Full text

Abstract:

Tese de doutoramento, Farmácia (Biofarmácia e Farmacocinética), Universidade de Lisboa, Faculdade de Farmácia, 2012<br>A key goal in pharmaceutical development of oral dosage forms is a good understanding of the in vivo and in vitro performance of the dosage form and to find a potential in vitro characteristic of an immediate release formulation that reflects its in vivo performance. In vitro dissolution testing provides useful information at several stages of the drug product development process and ideally should be used to assist scientists on excipients selection and manufacturing process

APA, Harvard, Vancouver, ISO, and other styles

We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!