Academic literature on the topic 'Pharmaceutical equivalence'

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Journal articles on the topic "Pharmaceutical equivalence"

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Park, Suck-Yong, and Sung-Up Choi. "Pharmaceutical Equivalence of Film-Coated and Chewable Tablets: A Comparative Dissolution Study Using Pulverized Chewable Tablets." Pharmaceuticals 17, no. 11 (2024): 1525. http://dx.doi.org/10.3390/ph17111525.

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Famotidine is a histamine H2 receptor antagonist used in the treatment of gastrointestinal disorders. It is available in multiple formulations, including film-coated tablets, chewable tablets, oral suspension, and injections. The purpose of this study was to develop and evaluate the film-coated tablet (FT) containing famotidine, magnesium hydroxide, and precipitated calcium carbonate, designed to be pharmaceutically equivalent to the marketed chewable tablet (CT). To achieve the pharmaceutical equivalence of two tablets, the dissolution profiles of FT should be similar to those of CT. However,
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Sánchez-Nava, Luis Alberto, Urias Bautista-Sánchez, and Ana Luisa Robles-Piedras. "Pharmaceutical equivalence and similarity studies of glibenclamide tablets." GSC Biological and Pharmaceutical Sciences 7, no. 1 (2019): 096–101. https://doi.org/10.5281/zenodo.4295724.

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The&nbsp;<em>in vitro</em>&nbsp;dissolution is the physicochemical test most used to estimate the release of the drug from the pharmaceutical form. Due to the close relationship between the dissolution rate of the drug&nbsp;<em>in vitro</em>&nbsp;and the absorption in vivo, the dissolution study is considered as the necessary and sufficient criterion to allow the commercialization of a pharmaceutical product. In this study, the similarity of the dissolution profiles of different products containing glibenclamide used in the Mexican Health Sector was compared. The dissolution profiles of 7 gene
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de Godoy Bertanha, Maria Luiza, and Felipe Rebello Lourenço. "Risk of false pharmaceutical equivalence (non-equivalence) decisions due to measurement uncertainty." Journal of Pharmaceutical and Biomedical Analysis 204 (September 2021): 114269. http://dx.doi.org/10.1016/j.jpba.2021.114269.

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Varillas, María A., Marta I. V. Brevedan, and Noelia L. Gonzalez Vidal. "Pharmaceutical Equivalence of Hydrochlorothiazide Tablets in Argentina." Dissolution Technologies 25, no. 4 (2018): 22–27. http://dx.doi.org/10.14227/dt250418p22.

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Varillas, María A., Marta I. V. Brevedan, and Noelia L. Gonzalez Vidal. "Pharmaceutical Equivalence of Losartan Potassium Tablets in Argentina." Dissolution Technologies 29, no. 2 (2022): GC2. http://dx.doi.org/10.14227/dt290222pgc2.

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Sánchez-Nava, Luis Alberto, Urias Bautista-Sánchez, and Ana Luisa Robles-Piedras. "Pharmaceutical equivalence and similarity studies of glibenclamide tablets." GSC Biological and Pharmaceutical Sciences 7, no. 1 (2019): 096–101. http://dx.doi.org/10.30574/gscbps.2019.7.1.0053.

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Hoffelder, Thomas, Rüdiger Gössl, and Stefan Wellek. "Multivariate Equivalence Tests for Use in Pharmaceutical Development." Journal of Biopharmaceutical Statistics 25, no. 3 (2014): 417–37. http://dx.doi.org/10.1080/10543406.2014.920344.

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Varillas, María A., Marta I. V. Brevedan, and Noelia L. Gonzalez Vidal. "Pharmaceutical Equivalence and Similarity Studies of Metoclopramide Tablets." Dissolution Technologies 25, no. 1 (2018): 14–21. http://dx.doi.org/10.14227/dt250118p14.

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TAKAHASHI, SHUJI, TEIKO TOYOGUCHI, TOHRU SHOJI, and YOSHITO NAKAGAWA. "Examination of Pharmaceutical Equivalence for Generic Drug (2)." Japanese Journal of Hospital Pharmacy 23, no. 5 (1997): 431–36. http://dx.doi.org/10.5649/jjphcs1975.23.431.

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YOSHIOKA, Sumie, Yukio ASO, and Shigeo KOJIMA. "Assessment of Shelf-Life Equivalence of Pharmaceutical Products." CHEMICAL & PHARMACEUTICAL BULLETIN 45, no. 9 (1997): 1482–84. http://dx.doi.org/10.1248/cpb.45.1482.

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Dissertations / Theses on the topic "Pharmaceutical equivalence"

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Lincoln-Kemp, Melissa. "Equivalence of international conference of harmonization guideline Q1B, option I and II photostability methods." View electronic thesis, 2008. http://dl.uncw.edu/etd/2008-2/rp/lincoln-kempm/melissalincoln-kemp.pdf.

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Mudyahoto, Nyengeterai Amanda. "Assessment of pharmaceutical equivalence of topical cream products containing hydrocortisone acetate using in vitro release testing (IVRT)." Thesis, Rhodes University, 2018. http://hdl.handle.net/10962/63384.

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Sausen, Tiago Rafael. "Desenvolvimento de comprimidos de clozapina obtidos pelo método de compressão direta." reponame:Biblioteca Digital de Teses e Dissertações da UFRGS, 2007. http://hdl.handle.net/10183/10879.

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O presente trabalho teve como objetivo o desenvolvimento de formulação para produção de comprimidos contendo 25 mg de clozapina através do método de compressão direta. A clozapina é utilizada no tratamento da psicose e consta na lista do Programa de Medicamentos Distribuídos em Caráter Excepcional do Ministério da Saúde. Para o desenvolvimento proposto, foi utilizado um desenho experimental do tipo desenho composto central a fim de avaliar a influência dos adjuvantes estearato de magnésio e croscarmelose sódica nas características dos comprimidos obtidos a partir de formulações que continham,
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Prado, Anelise Weich do. "OTIMIZAÇÃO DA AVALIAÇÃO DA MATÉRIA PRIMA E COMPRIMIDOS DE ATENOLOL: APLICAÇÃO EM PRODUÇÃO, CONTROLE E REGISTRO DE MEDICAMENTO GENÉRICO." Universidade Federal de Santa Maria, 2007. http://repositorio.ufsm.br/handle/1/5992.

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The atenolol is a selective β-blocker that acts specially on β-one adrenergic receptors of the heart, used in the control of high blood pressure, pectoris angine, cardiac arrhythmias and the treatment of miocardic stroke. This paper aimed to optimize the described methodologies for drugs and tablets of atenolol. It proposes to develop and validate simple and more accessible tests to evaluate atenolol tablets and raw material. It also emphasizes the ideal characteristics for drugs in the pre-formulation and development of the pharmaceutical form. Methodologies were developed and validated by HP
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Lima, Francisco Arnaldo Viana. "ImplantaÃÃo do Centro de EquivalÃncia FarmacÃutica da Unidade de Farmacologia ClÃnica - UFC." Universidade Federal do CearÃ, 2006. http://www.teses.ufc.br/tde_busca/arquivo.php?codArquivo=825.

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Conselho Nacional de Desenvolvimento CientÃfico e TecnolÃgico<br>A consolidaÃÃo do mercado de medicamentos genÃricos no Brasil representa importante estratÃgia governamental, uma vez que significarà maior acesso da populaÃÃo aos medicamentos. A Lei n 9.787, de 10 de fevereiro de 1999, estabeleceu as bases legais para a instituiÃÃo do medicamento genÃrico no PaÃs. Os laboratÃrios de equivalÃncia farmacÃutica fazem a verificaÃÃo entre dois medicamentos que contÃm a mesma molÃcula terapeuticamente ativa, na mesma quantidade e forma farmacÃutica, podendo ou nÃo conter excipientes idÃnticos, se sÃ
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Gotardelo, Daniel Riani. "AvaliaÃÃo do custo e equivalÃncia farmacÃutica de hidroclorotiazida em formulaÃÃes industrializadas e magistrais." Universidade Federal do CearÃ, 2006. http://www.teses.ufc.br/tde_busca/arquivo.php?codArquivo=2903.

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nÃo hÃ<br>A hidroclorotiazida à um dos fÃrmacos mais prescritos no tratamento da hipertensÃo arterial em todo mundo. Tem sido extensivamente utilizada no Brasil, em programa pÃblico do MinistÃrio da SaÃde. Visando à verificaÃÃo da qualidade e dos custos dos medicamentos contendo este fÃrmaco, foram realizados testes de equivalÃncia farmacÃutica em comprimidos industrializados e cÃpsulas manipuladas. O doseamento (determinaÃÃo do teor) foi feito por cromatografia lÃquida de alta eficiÃncia, tendo mostrado precisÃo e especificidade. Dentre os trÃs medicamentos industrializados (genÃrico, similar
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Pinheiro, Maria do Carmo Gomes. "EquivalÃncia farmacÃutica: proposta de manual para a implantaÃÃo e a padronizaÃÃo de centros em conformidade com as normas tÃcnicas e a legislaÃÃo sanitÃria vigentes." Universidade Federal do CearÃ, 2004. http://www.teses.ufc.br/tde_busca/arquivo.php?codArquivo=346.

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CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior<br>Com a implantaÃÃo da polÃtica de incentivo ao medicamento genÃrico, no Brasil, em 1999, os estudos de equivalÃncia farmacÃutica tornaram-se elementos estratÃgicos para a sua implementaÃÃo e seu Ãxito. Para a realizaÃÃo desses estudos, foi criada uma rede de laboratÃrios, habilitados e supervisionados pela AgÃncia Nacional de VigilÃncia SanitÃria, sob a denominaÃÃo de centros de equivalÃncia farmacÃutica (EQFAR), que passaram a integrar a Rede Brasileira de LaboratÃrios AnalÃticos em SaÃde (Reblas). Os critÃrios para a habilitaÃÃo
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ALVES, Carina Pimentel Itapema. "Desenvolvimento farmacotécnico e analítico de comprimidos revestidos de montelucaste: equivalência farmacêutica e bioequivalência." Universidade Federal de Goiás, 2011. http://repositorio.bc.ufg.br/tede/handle/tde/1548.

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Made available in DSpace on 2014-07-29T15:25:22Z (GMT). No. of bitstreams: 1 Tese Carina-pos defesa.pdf: 485460 bytes, checksum: 2ca505db4ca73a05349dd92fbfc7df1d (MD5) Previous issue date: 2011-03-18<br>Montelukast is a potent reversible selective inhibitor of cysteinilleukotrien- 1 receptor, avoiding that these mediators promote the asthmatic response. Its commercialization in Brazil, as a terminated product, is protected by patent up to 2010. Once the active ingredient Montelukast is recent in the pharmaceutical market and there is no methodology description in official compendiums capable
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Ganti, Satyakala. "DEVELOPMENT OF HPLC METHODS FOR PHARMACEUTICALLY RELEVANT MOLECULES; METHOD TRANSFER TO UPLC: COMPARING METHODS STATISTICALLY FOR EQUIVALENCE." Diss., Temple University Libraries, 2011. http://cdm16002.contentdm.oclc.org/cdm/ref/collection/p245801coll10/id/118587.

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Chemistry<br>Ph.D.<br>High Pressure Liquid Chromatography (HPLC) is a well-known and widely used analytical technique which is prevalent throughout the pharmaceutical industry as a research tool. Despite its prominence HPLC possesses some disadvantages, most notably slow analysis time and large consumption of organic solvents. Ultra Pressure Liquid Chromatography (UPLC) is a relatively new technique which offers the same separation capabilities of HPLC with the added benefits of reduced run time and lower solvent consumption. One of the key developments which facilitate the new UPLC technology
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Loh, Shihk-Hurng. "Pharmacology and physiology of H'+- equivalent membrane transport in the mammalian ventricular mycocyte." Thesis, University of Oxford, 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.390485.

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Books on the topic "Pharmaceutical equivalence"

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G, Welling Peter, Tse Francis L. S, and Dighe Shrikant V, eds. Pharmaceutical bioequivalence. Dekker, 1991.

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United States. Food and Drug Administration., ed. Bioequivalence of solid oral dosage forms: A presentation to the U.S. Food and Drug Administration hearing on bioequivalence of solid oral dosage forms September 29 - October 1, 1986. The Association, 1986.

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Gourley, D. R. The APhA complete review for the Foreign Pharmacy Graduate Equivalency Examination. Edited by American Pharmacists Association. American Pharmacists Association, 2010.

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Shargel, Leon. Generic drug product development. CRC, 2007.

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Isadore, Kanfer, and Shargel Leon 1941-, eds. Generic drug product development: Bioequivalence issues. Informa Healthcare, 2008.

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Ferm, Max A. How to save dollars with generic drugs: A consumer's guide to high-quality, low-priced medicines. W. Morrow, 1985.

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Jun, Shao, ed. Statistics in drug research: Methodologies and recent developments. M. Dekker, 2002.

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Niazi, Sarfaraz K. Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences). Informa Healthcare, 2007.

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Mosby's genRx: The complete reference for generic and brand drugs. 9th ed. Mosby, 1999.

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Publishing, Springhouse. Physician's Drug Handbook. Springhouse Publishing Co ,U.S., 1989.

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Book chapters on the topic "Pharmaceutical equivalence"

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Kanfer, Isadore. "Bioequivalence, Pharmaceutical Equivalence, and Biowaivers." In Percutaneous Absorption, 5th ed. CRC Press, 2021. http://dx.doi.org/10.1201/9780429202971-60.

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Nauta, Jozef. "Vaccine Equivalence and Non-inferiority Trials." In Springer Series in Pharmaceutical Statistics. Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-37693-2_6.

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Phan, Khanh, Vânia R. Leite-Silva, Sangeeta Prakash, et al. "Dermatological Product Sensorial Properties: Bridging Pharmaceutical and Therapeutic Equivalence." In AAPS Introductions in the Pharmaceutical Sciences. Springer Nature Switzerland, 2025. https://doi.org/10.1007/978-3-031-80525-7_9.

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Kieser, Meinhard. "Comparison of Two Groups for Normally Distributed Outcomes and Test for Equivalence." In Springer Series in Pharmaceutical Statistics. Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-49528-2_10.

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Kieser, Meinhard. "Comparison of Two Groups for Normally Distributed Outcomes and Test for Equivalence." In Springer Series in Pharmaceutical Statistics. Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-49528-2_24.

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Nahler, Gerhard. "pharmaceutical equivalent." In Dictionary of Pharmaceutical Medicine. Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_1037.

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Nahler, Gerhard. "chemical equivalents." In Dictionary of Pharmaceutical Medicine. Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_182.

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Nahler, Gerhard. "biologic equivalent." In Dictionary of Pharmaceutical Medicine. Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_122.

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Nahler, Gerhard. "therapeutic equivalent." In Dictionary of Pharmaceutical Medicine. Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_1389.

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Nahler, Gerhard. "healthy-year equivalent (HYE)." In Dictionary of Pharmaceutical Medicine. Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_641.

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Conference papers on the topic "Pharmaceutical equivalence"

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Nuñez Bracamonte, S., MC González Pérez-Crespo, E. Conesa Nicolás, et al. "4CPS-152 Analysis of pharmaceutical interventions in the exchange of therapeutic equivalents." In 25th EAHP Congress, 25th–27th March 2020, Gothenburg, Sweden. British Medical Journal Publishing Group, 2020. http://dx.doi.org/10.1136/ejhpharm-2020-eahpconf.253.

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Shi, Gengbei, and Robin N. Coger. "Enhanced Oxygen Delivery to Liver Tissue Equivalent by Perfluorocarbon." In ASME 2010 Summer Bioengineering Conference. American Society of Mechanical Engineers, 2010. http://dx.doi.org/10.1115/sbc2010-19190.

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Bioartificial Liver Devices (BALs) have the potential to serve as a bridge strategy for patients awaiting liver transplants, and also show promise as drug testing platforms for the pharmaceutical industry [1]. Yet the limitations of O2 transport through the 3D tissue structures of current designs continue to present engineering challenges. In previous work our group successfully improved O2 availability for hepatocytes by introducing micropathways within the BAL’s cellular space [3–5]. The current study investigates the benefits of increasing O2 availability of the flow medium via perfluorocar
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Shahidi, Seyedehsan, Charles R. Koch, and Subir Bhattacharjee. "A Milli-Fluidic Device for Electrical Impedance Spectroscopy of Complex Liquids." In ASME 2013 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2013. http://dx.doi.org/10.1115/imece2013-65293.

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Rapid characterization of complex liquids such as solutions, mixtures, dispersions, and emulsions is useful in a variety of industrial applications ranging from cosmetics, pharmaceuticals, to petroleum production. An electrical impedance spectroscopy (EIS) based technique for rapidly determining the characteristics of liquid-liquid mixtures is presented in this study. A milli-fluidic liquid film impedance measurement cell is developed employing 3D printing technology. The cell is tested using glycerol-water mixtures followed by castor oil in water emulsion samples. Frequency response analysis
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Wang, Shuyu, Shifeng Yu, and Lei Zuo. "Characterization of a Microfabricated Differential Scanning Calorimeter." In ASME 2015 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference. American Society of Mechanical Engineers, 2015. http://dx.doi.org/10.1115/detc2015-46136.

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Calorimeters are critical tools for structural based drug design and drug stability assessment. Current pharmaceutical industry is seeking for high throughput calorimeters to reduce the research time and expenditure. MEMS-based calorimeter is a potential solution for it, since they are miniaturized to detect the enthalpy change during macro molecular interaction with smaller amount of samples, shorter time and could easily enable parallel measurement. Consequently, we present a Differential Scanning Calorimeter (DSC) that requires 2μL sample volume. It has high thermal insulation (1210μW/K), s
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Chizzola, Remigius, Harinder Makkar, Ellen McGrath, and Papu Haroon. "EXTRACTION OF ANTIOXIDANTS FROM MORINGA OLEIFERA LEAVES, STABILITY OF THE RESULTING ANTIOXIDANTS, AND USE OF THE REMAINING RESIDUE AS LIVESTOCK FEED." In 23rd SGEM International Multidisciplinary Scientific GeoConference 2023. STEF92 Technology, 2023. http://dx.doi.org/10.5593/sgem2023v/6.2/s25.27.

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Moringa oleifera, commonly known as horse radish tree or drumstick tree is a perennial multipurpose tropical tree. It can be used as medicine, cosmetic and functional food, among others. The benefits of using the leaves are ascribed to the presence of a number of antioxidants. Nowadays it is widely cultivated and naturalized in many countries. Simple methods to extract antioxidants from Moringa leaf are lacking, which were established, stability of antioxidants was assessed, and residue left after extraction was explored for use as animal feed, with the aim to scale-up the process to industria
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Reports on the topic "Pharmaceutical equivalence"

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Ruxrungtham, Kiat, Vorapot Sapsirisavat, Vorasit Vongsutilers, et al. Pharmaceutical equivalence drugs assessment-I (PEDA-I) : assess the pharmaceutical equivalence of generic antiretrovirals distributed in Thailand : Final report. Chulalongkorn University, 2016. https://doi.org/10.58837/chula.res.2016.30.

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Objectives: Ensuring that medicines meet quality standards is mandatory for ensuring safety and efficacy. There have been occasional reports of substandard generic medicines, especially in resource-limiting settings where policies to control quality may be less rigorous. As HIV treatment in Thailand depends mostly on affordable generic antiretrovirals (ARV), we performed quality assurance testing of several generic ARV available from different sources in Thailand and a source from Vietnam. Methods: We sampled Tenofovir 300 mg, Efavirenz 600 mg and Lopinavir/ritonavir 200/50mg from 10 primary h
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Ciapponi, Agustín. What are the effects of reference pricing and other pharmaceutical pricing and purchasing policies? SUPPORT, 2016. http://dx.doi.org/10.30846/1608143.

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Pharmaceutical pricing and purchasing policies are used to determine or affect the prices that are paid for drugs. This review found evidence for reference pricing, index pricing, and maximum prices. In reference pricing a reference drug is chosen amongst identical or similar medicines or therapeutically equivalent and the price of the reference drug is reimbursed for all the drugs in that group of drugs. For drugs that are more expensive than the reference drug, the patient has to pay the cost above the reference price. An index price is the maximum refundable price to pharmacies for drugs wi
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Gutiérrez, Catalina, and Úrsula Giedion. How Many Healthy Life years could Countries in Latin America and the Caribbean Gain with a Better Allocation of Pharmaceutical Spending?: Case Studies for Chile, Colombia, and the Dominican Republic. Inter-American Development Bank, 2023. https://doi.org/10.18235/0005161.

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Health spending is increasing globally due to demographic and epidemiological changes, rising demand for services driven by higher incomes, aging populations, and the emergence of expensive new health technologies. In Latin America and the Caribbean (LAC), health expenditure has risen from 6.6% to 7.9% of GDP over the past two decades. By 2030, it is expected to increase by another 2 percentage points. This projection excludes additional investments required to strengthen health systems post-pandemic. Given fiscal constraints caused by the pandemics economic impact, rising debt, and macroecono
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