Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 2.811
Filtrar
1.
AAPS J ; 23(6): 112, 2021 10 15.
Artigo em Inglês | MEDLINE | ID: mdl-34654974

RESUMO

Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the pharmaceutical quality environment. Globalization of the pharmaceutical industry, increasingly rapid development of novel therapies, and adoption of new manufacturing techniques have presented numerous challenges for the established regulatory framework and quality environment and are impacting the approaches utilized to ensure the quality of pharmaceutical products. Regulators, industry, and standards-setting organizations have begun to recognize the need to rely more on integrated risk-based approaches and to create more nimble and flexible standards to complement these efforts. They also increasingly have recognized that quality needs to be built into systems and processes throughout the lifecycle of the product. Moreover, the recent COVID-19 crisis has emphasized the need to adopt practices that better promote global supply chain resilience. In this paper, the USP Quality Advisory Group explores the various paradigm shifts currently impacting pharmaceutical quality and the approaches that are being taken to adapt to this new environment. Broad adoption of the Analytical Procedure Lifecycle approach, improved data management, and utilization of digital technologies are identified as potential solutions that can help meet the challenges of these quality paradigm shifts. Further discussion and collaboration among stakeholders are needed to pursue these and other solutions that can ensure a continued focus on quality while facilitating pharmaceutical innovation and development.


Assuntos
COVID-19/epidemiologia , Indústria Farmacêutica/normas , Preparações Farmacêuticas/provisão & distribuição , Preparações Farmacêuticas/normas , Farmacopeias como Assunto/normas , Controle de Qualidade , COVID-19/prevenção & controle , Indústria Farmacêutica/métodos , Humanos , Tecnologia Farmacêutica/métodos , Tecnologia Farmacêutica/normas , Estados Unidos/epidemiologia
2.
J R Soc Med ; 114(6): 313-322, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34132132

RESUMO

The physician and physiologist Dr William Harvey is known for having discovered that the heart pumps arterial blood round the whole body and receives venous blood from the periphery, which it forwards to the lungs for reoxygenation. Harvey's discovery was based on anatomical and physiological evidence and experiments using ligatures of varying tensions. As a clinician, however, Harvey does not appear to have appreciated the value of experiments in assessing treatment effects. Although he criticised Galenic views about the clinical value of experience and authority in the absence of accompanying empirical evidence, two handwritten prescriptions that he wrote for his friend and future biographer John Aubrey provide evidence that he conformed with Galenic theory when it came to drug therapy in clinical practice. This was consistent with his senior position in the College of Physicians, whose Pharmacopoeia Londinensis was based on Galenic principles, an appreciation of which was required for entry into the College. Harvey's prescriptions reflect this and open a window onto 17th-century therapeutic practice and the personal elements on which such practice was sometimes based.


Assuntos
Pesquisa Biomédica/história , Cardiologia/história , Prescrições de Medicamentos/história , Pesquisa Empírica , Médicos/história , Padrões de Prática Médica/história , Circulação Sanguínea , Ensaios Clínicos como Assunto , Coração , História do Século XVII , Farmacopeias como Assunto/história , Filosofia Médica/história , Projetos de Pesquisa , Sociedades Médicas/história , Redação
3.
Yakugaku Zasshi ; 141(4): 591-598, 2021.
Artigo em Japonês | MEDLINE | ID: mdl-33790124

RESUMO

The Japanese Pharmacopoeia (JP) is an official normative guide for maintaining the authenticity of properties and qualities of medicine in Japan. The JP is revised every 5 years, and partial amendments are made from time to time to keep abreast with progress in science and technology and international harmonization. We are conducting a related study on the elimination of toxic reagents from the JP. The elimination of toxic reagents is an important study in relation to the five pillars of the revision of the 18th JP, "Improvement in quality by proactively introducing the latest knowledge and technological advances". In addition, "Internationalization of the JP" is an important issue to be addressed during revision of the JP. Considering international harmonization of the JP, it is important to incorporate the test methods that have been used in other pharmacopoeia, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP) in the JP. To achieve the above, herein, we selected clonidine hydrochloride, which is listed in the 17th JP. A potentiometric titration method is used as a quantitative method for clonidine hydrochloride in the 17th JP; in contrast, a HPLC method is utilized in the USP and the EP. In this study, we synthesized impurities of clonidine hydrochloride and determined their purities using quantitative NMR. In addition, the complete separation conditions of these compounds by HPLC were examined, and simultaneous analysis was performed.


Assuntos
Cromatografia Líquida de Alta Pressão/métodos , Cromatografia Líquida de Alta Pressão/normas , Clonidina/análise , Internacionalidade , Farmacopeias como Assunto/normas , Japão , Espectroscopia de Ressonância Magnética/métodos
4.
J Manag Care Spec Pharm ; 27(4): 533-535, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33769853

RESUMO

DISCLOSURES: No funding supported the writing of this commentary. The author is employed by US Pharmacopeia. This article was requested by JMCP as a response to the companion Viewpoints article "Decision Makers Need an Approach to Determine Digital Therapeutic Product Quality, Access, and Appropriate Use" by Parcher and Coder (see page 536). Digital Therapeutics Alliance, which is mentioned in this article, is a member of the USP Convention.


Assuntos
Farmacopeias como Assunto , Telemedicina , Confiança , Humanos , Estados Unidos
5.
Drug Ther Bull ; 59(5): 71-72, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33692150

RESUMO

The BNF is jointly published by the Royal Pharmaceutical Society and BMJ. BNF is published in print twice a year and interim updates are issued and published monthly in the digital versions. The following summary provides a brief description of some of the key changes that have been made to BNF content since the last print edition (BNF 80) was published.


Assuntos
Preparações Farmacêuticas/administração & dosagem , Farmacopeias como Assunto , Humanos , Guias de Prática Clínica como Assunto , Sociedades Médicas , Sociedades Farmacêuticas , Reino Unido
6.
J Ethnopharmacol ; 268: 113685, 2021 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-33309919

RESUMO

ETHNOPHARMACOLOGICAL RELEVANCE: Herbal medicine in Russia has a long history starting with handwritten herbalist manuscripts from the Middle Ages to the officinal Pharmacopoeia of the 21st century. The "herbophilious" Russian population has accumulated a lot of knowledge about the beneficial effects of local medicinal plants. Yet, for a long time, Russian traditional and officinal herbal medicine was not well known to the international audience. In our previous comprehensive review, we discussed the pharmacological effects of specific plants included in the 11th edition of the Pharmacopoeia of the USSR, which was also for a while used in Russia. The 14th edition of the Russian Federation's State Pharmacopoeia was implemented in 2018. AIM OF THE REVIEW: The aims of the present review are: (i) to trace the evolution of medicinal plant handling from handwritten herbalist manuscripts to Pharmacopoeias; (ii) to describe the modern situation with regulatory documents for herbal medicinal products and their updated classification; (iii) to summarize and discuss the pharmacology, safety, and clinical data for new plants, which are included in the new edition of the Pharmacopoeia. METHODS: New medicinal plants included in the 14th edition of the Russian Federation's State Pharmacopoeia were selected. We carefully searched the scientific literature for data related to traditional use, pharmacological, clinical application, and safety. The information was collected from local libraries in Saint-Petersburg, the online databases E-library.ru, Scopus, Web of Science, and the search engine Google scholar. RESULTS: Investigating the evolution of all medicinal plants referred to in the Russian Pharmacopoeias led us to the identification of ten medicinal plants that were present in all editions of civilian Russian Pharmacopoeias starting from 1778. In the 14th edition of the modern Russian Pharmacopoeia, medicinal plants are described in 107 monographs. Altogether, 25 new monographs were included in the 14th edition, and one monograph was excluded in comparison to the 11th edition. Some of the included plants are not endemic to Russia and do not have a history of traditional use, or on the other hand, are widely used in Western medicine. For 15 plants, we described the specificity of their application in Russian traditional medicine along with the claimed dosages and indications in officinal medicine. The pharmacology, safety, and clinical data are summarized and assessed for nine plants, underlining their therapeutic potential and significance for global phytopharmacotherapy. CONCLUSIONS: In this review, we highlight the therapeutical potential of new plants included in the modern edition of the Russian Pharmacopoeia. We hope that these plants will play an imperative role in drug development and will have a priority for future detailed research.


Assuntos
Medicina Tradicional/métodos , Farmacopeias como Assunto/classificação , Extratos Vegetais/classificação , Extratos Vegetais/uso terapêutico , Plantas Medicinais/classificação , Humanos , Medicina Tradicional/tendências , Plantas Medicinais/química , Federação Russa/etnologia
7.
J Ethnopharmacol ; 265: 113115, 2021 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-32891812

RESUMO

ETHNOPHARMACOLOGICAL RELEVANCE: Ancient Egyptian texts only offer glimpses into their conceptual understandings of the inner-body and illness manifestation. Explanations of how prescribed materia medica were believed to work are rare and obscure, often resulting in modern approximations for ancient terminology such as 'ra-ib'-an ancient Egyptian classification predominantly translated as 'stomach'-leading to misunderstandings of historical texts, and therefore their use of pharmacology. AIM OF THE STUDY: To investigate the ra-ib and the explanatory models of illness from the Egyptian perspective, and to explore the link between these and the prescribed selection of materia medica. To then compare the conceptual mechanics of these treatment strategies with those of another non-Western tradition-namely Traditional Chinese Medicine (TCM)-to provide further insight into potential conceptual frameworks. MATERIALS AND METHODS: We conducted a case study of a unit of Ancient Egyptian texts focusing on the ra-ib. Totalling 34 prescriptions, the first stage lexicographically analysed the texts using cognitive linguistic and translation theories to produce our new understanding. This enabled our comparison of the mechanics of materia medica usage within these texts with those found in TCM outlined by the Pharmacopoeia of the Peoples Republic of Pharmacopeia of the People's Republic of China 2015 for the relevant ingredients. RESULTS: the study demonstrated that-rather than denoting the organ 'stomach'-ra-ib instead constitutes a system running from the mouth, downward to the anus. This is best translated as 'inner thoroughfare', and changes the way in which we attempt to understand potential motivations in the selection of ingredients. By exploring common themes in the use of eleven securely translated ingredients from the Egyptian corpus and the Pharmacopoeia of the People's Republic of China-representing a modern traditional system which understands the body via a series of interconnected systems-we were able to highlight certain themes which might be 'universal' to system-based traditions; this provided new insights into the Egyptian motivations for treatment selection. CONCLUSIONS: Having gained the ancient view of the body and illness, cultural comparisons are important for providing further potential insights and clarifications of a discontinued historical healing tradition. The new understanding of the ra-ib from our study greatly changes the way in which we understand the dynamics of Egyptian ethnopharmacological source material from this period.


Assuntos
Medicamentos de Ervas Chinesas/farmacologia , Materia Medica/história , Medicina Tradicional Chinesa/métodos , Antigo Egito , Etnofarmacologia , História Antiga , Humanos , Materia Medica/farmacologia , Farmacopeias como Assunto
8.
Int J Technol Assess Health Care ; 37: e8, 2020 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-33148373

RESUMO

A central function of health technology assessment (HTA) agencies is the production of HTA reports to support evidence-informed policy and decision making. HTA agencies are interested in understanding the mechanisms of HTA impact, which can be understood as the influence or impact of HTA report findings on decision making at various levels of the health system. The members of the International Network of Agencies for HTA (INAHTA) meet at their annual Congress where impact story sharing is one important activity. This paper summarizes four stories of HTA impact that were finalists for the David Hailey Award for Best Impact Story.The methods to measure impact include: document review; claims analysis and review of reimbursement status; citation analysis; qualitative evaluation of stakeholders' views; and review of media response. HTA agency staff also observed changes in government activities and priorities based on the HTA. Impact assessment can provide information to improve the HTA process, for example, the value of patient and clinician engagement in the HTA process to better define the assessment question and literature reviews in a more holistic and balanced way.HTA reports produced by publicly funded HTA agencies are valued by health systems around the globe as they support decision making regarding the appropriate use, pricing, reimbursement, and disinvestment of health technologies. HTAs can also have a positive impact on information sharing between different levels of government and across stakeholder groups. These stories show how HTA can have a significant impact, irrespective of the health system and health technology being assessed.


Assuntos
Tomada de Decisões , Avaliação da Tecnologia Biomédica/organização & administração , Distinções e Prêmios , Congressos como Assunto/organização & administração , Desfibriladores Implantáveis , Genômica/organização & administração , Humanos , Participação do Paciente/métodos , Farmacopeias como Assunto/normas , Políticas , Avaliação da Tecnologia Biomédica/normas , Vertebroplastia/economia , Vertebroplastia/métodos
9.
Chem Pharm Bull (Tokyo) ; 68(11): 1034-1048, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33132370

RESUMO

In line with the recent globalization of the drug supply chain and promotion of the use of generic drugs worldwide, quality assurance is required for drugs globally. In particular, controlling impurities is one of the biggest areas of interest regarding pharmaceutical quality, and it is desirable that the latest scientific standards harmonized in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are not only implemented in approval applications but also incorporated in pharmacopoeias which are public standards to ensure pharmaceutical quality more widely. However, incorporation into a pharmacopoeia takes time because careful consideration is required owing to the characteristics of a pharmacopoeia that is widely used for drugs, including those already on the market. To consider a smooth approach for the incorporation, we retrospectively examined approaches to incorporate the concepts of the ICH Q3C, Q3D, and M7 guidelines covering residual solvents, elemental impurities, and mutagenic impurities which are particularly toxic impurities into the European Pharmacopoeia, United States Pharmacopeia-National Formulary, and Japanese Pharmacopoeia, with approaches to implement these guidelines into approval processes in Europe, the U.S., and Japan. We also identified barriers and facilitators to this goal via cause and effect analysis. Moreover, we developed a logic model for the smooth incorporation of the concepts of impurity-related ICH guidelines. We expect that our proposed approach will be applied as a framework to smoothly incorporate the results of international harmonization activities for controlling impurities into each pharmacopoeia.


Assuntos
Medicamentos Genéricos/normas , Modelos Teóricos , Contaminação de Medicamentos/prevenção & controle , Medicamentos Genéricos/análise , Europa (Continente) , Guias como Assunto , Japão , Farmacopeias como Assunto , Estados Unidos
10.
Drug Ther Bull ; 58(11): 164-165, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32917734

RESUMO

The BNF is jointly published by the Royal Pharmaceutical Society and BMJ. BNF is published in print twice a year and interim updates are issued and published monthly in the digital versions. The following summary provides a brief description of some recent key changes that have been made to BNF content.


Assuntos
Preparações Farmacêuticas/administração & dosagem , Farmacopeias como Assunto , Guias como Assunto , Humanos , Revisão da Pesquisa por Pares , Sociedades Médicas , Reino Unido
11.
Yakugaku Zasshi ; 140(8): 1063-1069, 2020.
Artigo em Japonês | MEDLINE | ID: mdl-32741864

RESUMO

Quantitative NMR (qNMR) has been developed as an absolute quantitation method to determine the purity or content of organic compounds including marker compounds in crude drugs. The "qNMR test" has been introduced into the crude-drug section of the Japanese Pharmacopoeia (JP) for determining the purity of reagents used for the assay in the JP. In Supplement II to the JP 17th edition published in June 2019, fifteen compounds adopted qNMR test were listed as the reagents for the assay. To establish the "qNMR test" in the crude drug section of the JP, there were several problems to be solved. Previously, we reported that the handling impurity signals from reference substances and targeted marker compounds, chemical shifts of reference substances, and peak unity of signals of targeted marker compounds are important factors to conduct qNMR measurements with intended accuracy. In this study, we investigated that the hygroscopicity of reagents could cause the changes in the compounds' purity depending on increasing their water content. Twenty-one standard products used for the crude-drug test in JP were examined by water sorption-desorption analysis, and ginsenosides and saikosaponins were found to be hygroscopic. To prepare a sample solution of saikosaponin b2 for qNMR analysis, samples need to be maintained for 18 h at 25°C and 76% relative humidity; further, samples need to be weighed at the same humidity for the qNMR analysis.


Assuntos
Contaminação de Medicamentos/prevenção & controle , Higroscópicos/química , Higroscópicos/normas , Indicadores e Reagentes/normas , Espectroscopia de Ressonância Magnética/métodos , Farmacopeias como Assunto/normas , Ginsenosídeos/química , Ginsenosídeos/normas , Umidade , Japão , Ácido Oleanólico/análogos & derivados , Ácido Oleanólico/química , Ácido Oleanólico/normas , Psicoterapia Breve , Saponinas/química , Saponinas/normas , Temperatura , Água/análise
12.
Pharmeur Bio Sci Notes ; 2020: 141-160, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32788037

RESUMO

For acellular pertussis (aP) vaccines, the current European Pharmacopoeia (Ph. Eur.) monograph Pertussis vaccine (acellular, component, adsorbed) (1356) requires an immunogenicity assay in mice or guinea pigs to assess the potency of each lot of vaccine (Ph. Eur. general method 2.7.16. Assay of pertussis vaccine (acellular)). This biological assay, carried out on the final bulk of the vaccine lot, is based on the measurement of the specific antibody response to the 5 antigenic components (pertussis toxin (PT), Fimbrial haemagglutinin (FHA), pertactin (PRN) and Fimbriae 2 and 3 (FIM2/3)) that are present in the combined aP vaccines. In the mouse assay, serum antibody levels are measured by ELISA. The immunogenicity of a vaccine under test is estimated versus a homologous reference vaccine and a reference antiserum e.g. the first Ph. Eur. Biological Reference Preparation for Bordetella (B.) pertussis mouse anti-serum (BRP1), established in 1998, is used to normalise the titre of antibodies (expressed in ELISA Units (ELU)/mL). In anticipation of the depletion of BRP1 stocks, a project was launched in 2013 by the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) in order to establish a new standardised reference serum. The project, referred to herein as BSP129, was conducted in 2 phases: 1) the production and characterisation of a mouse serum pool (using a multicomponent aP vaccine marketed in Canada similar to the vaccine used in the BRP1 production as immunogen) and of candidate BRP batches (cBRPs) and 2) an international collaborative study aimed at calibrating the cBRPs in terms of antibody levels against PT, FHA, PRN and FIM2/3. This article presents the design and results of the first phase of the collaborative study to establish the optimal conditions for immunisation and bleeding of mice in order to produce a large pool of hyper-immune serum against the 5 antigens. After the characterisation of this pool, cBRP pilot lots were manufactured by freeze-drying diluted solutions of the hyper-immune serum pool. The pilot lots were then characterised in two Official Medicines Control Laboratories (OMCLs) for their antibody contents against aP vaccine antigens using in-house ELISA (based on methods developed by 2 European vaccine manufacturers) and Multiplex Immunoassay (MIA) methods. The antibody titres recovered demonstrated that a dilution factor of 1/40 could be considered for the scaled-up manufacture of candidate reference preparations (cBRPs). Three batches (15 000 vials) of cBRP were manufactured and fully characterised. In light of the data obtained, and although titration results between the ELISA methods were sometimes discrepant, it was agreed that the establishment study (phase 2) could be launched. Real-time and accelerated stability studies were also included in the first study phase to document the stability of the cBRPs in freeze-dried form and after reconstitution and storage at -20°C±5°C. The results showed that the stability of the freeze-dried cBRPs at usual storage and shipment temperatures is acceptable and that reconstituted cBRP solutions are stable for 12 months at -20°C±5°C. It could therefore be recommended to freeze small aliquots of the 1 mL solution obtained by the reconstitution of one BRP vial in order to store them for use in separate assays. With the application of this strategy, the stocks of the BRP1 replacement batches should cover the needs of OMCLs and manufacturers for at least the next decade.


Assuntos
Bordetella pertussis/efeitos dos fármacos , Soros Imunes/efeitos dos fármacos , Cooperação Internacional , Laboratórios/normas , Vacina contra Coqueluche/normas , Farmacopeias como Assunto/normas , Animais , Bordetella pertussis/imunologia , Europa (Continente) , Feminino , Soros Imunes/sangue , Soros Imunes/imunologia , Imunização/métodos , Imunização/normas , Camundongos , Vacina contra Coqueluche/administração & dosagem , Vacina contra Coqueluche/imunologia , Padrões de Referência
13.
Pharmeur Bio Sci Notes ; 2020: 161-202, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32788038

RESUMO

A project aimed at establishing replacement batches for the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) Bordetella (B.) pertussis mouse antiserum was started in 2013 under the aegis of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM). This BRP is used for the immunogenicity assay in mice to assess the potency of acellular pertussis (aP) vaccines as described in Ph. Eur. general method 2.7.16. Assay of pertussis vaccine (acellular). In a preliminary phase of the project (referred to herein as BSP129 phase 1) a hyper-immune serum pool was produced in mice using a combined aP vaccine as immunogen. This pool was used to generate 3 freeze-dried candidate (c) B. pertussis anti-mouse serum BRP batches (cBRP2, cBRP3 and cBRP4). After the pre-qualification that showed their suitability as candidate batches, an international collaborative study (BSP129 phase 2) was carried out in order to standardise these 3 batches against the current BRP1 in terms of anti-PT, -FHA, -PRN and -FIM2/3 antibody contents. For the sake of continuity with the standardisation of BRP1, the corresponding WHO standard (1RR 97/642) was introduced as a second reference for the calibration of the 3 candidate BRPs. Eleven laboratories took part in phase 2. Ten of them performed the ELISA method they use routinely for aP vaccine batch release and one laboratory performed the Multiplex Immunoassay (MIA) as an alternative test. Four participants titrated the antibodies against all 5 pertussis antigens, 5 participants determined the antibody content against 3 antigens (PT, FHA, PRN), one participant titrated the antibodies against PT and FHA antigens and one laboratory determined the antibody content for the PT antigen only. Details of all ELISA methods used were analysed to evaluate their impact on the calibration of the cBRPs. The variability of the results in relation to the nature and methodology of the tests appeared rather limited. Discrepant titres of cBRPs were measured depending on the reference used: the use of the 1RR induced an overestimation (in 8 out of 11 laboratories) and a large inter-laboratory variation in the calculated titres. Regardless of the reference used, equivalency between the calculated titres of cBRP2 and cBRP3 was observed, whilst cBRP4 had systematically lower titres for all antibodies against the 5 acellular pertussis vaccine components. Based on these observations, it was decided to establish the candidate BRP batches against BRP1 and to assign the following potencies based on the mean values determined through centrally calculated results of the calibration assays performed by ELISA in BSP129 phase 2: For cBRP2 and cBRP3 Anti-pertussis toxin: 37 ELISA Units (ELU) per vial Anti-filamentous haemagglutinin: 114 ELU per vial Anti-pertactin: 44 ELU per vial Anti-fimbrial agglutinogens (FIM2/3): 25 ELU per vial For cBRP4 Anti-pertussis toxin: 32 ELU per vial Anti-filamentous haemagglutinin: 98 ELU per vial Anti-pertactin 38 ELU per vial Anti-fimbrial agglutinogens (FIM2/3):23 ELU per vial In February 2018, BRP2, BRP3 and BRP4 were adopted by correspondence by the Ph. Eur. Commission.


Assuntos
Bordetella pertussis/efeitos dos fármacos , Cooperação Internacional , Laboratórios/normas , Vacina contra Coqueluche/normas , Farmacopeias como Assunto/normas , Organização Mundial da Saúde , Animais , Bordetella pertussis/imunologia , Hemaglutininas/sangue , Hemaglutininas/imunologia , Soros Imunes/sangue , Soros Imunes/imunologia , Camundongos , Toxina Pertussis/sangue , Toxina Pertussis/imunologia , Vacina contra Coqueluche/administração & dosagem , Padrões de Referência
15.
Pharmeur Bio Sci Notes ; 2020: 125-140, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32677612

RESUMO

Equine influenza (EI) is an important respiratory disease of horses, with welfare and economic consequences. Vaccination remains one of the most efficient prevention methods available. Equine influenza virus (EIV) is constantly evolving and consequently EI vaccines need to be updated on a regular basis. In 2010, the World Organisation for Animal Health (OIE) Expert Surveillance Panel (ESP) on EI provided a new recommendation for EI vaccine strain composition, including the incorporation of representative EIV strains of both Florida Clade 1 and Clade 2 sub-lineages (FC1 and FC2, respectively). In this context, the European Pharmacopoeia (Ph. Eur.) - OIE reference panel for EI had to be complemented by an antiserum raised in horses against the FC2 representative EIV strain A/eq/Richmond/1/07. An international collaborative study was organised and managed by the European Directorate for the Quality of Medicines and HealthCare (EDQM) within the framework of its Biological Standardisation Programme (BSP). The study aimed at evaluating a new candidate reference for use as a common OIE International Standard/Ph. Eur. Biological Reference Preparation (BRP) horse antiserum to FC2 EIV A/equine/Richmond/1/07. The standard was to be established using the SRH and HI tests for subsequent use in immunogenicity, efficacy and batch potency assay of EI vaccines as a Ph. Eur. BRP (Ph. Eur. monograph 0249) and for use in clinical diagnostic tests as an OIE-approved International Standard Reagent (OIE chapter 3.5.7). The collaborative study confirmed the suitability of the candidate and an SRH titre was assigned. The candidate was adopted as a BRP by the Ph. Eur. Commission and approved by the OIE Biological Standards Commission as an International Standard Serum in November 2017 and February 2018, respectively.


Assuntos
Soros Imunes/sangue , Vírus da Influenza A Subtipo H3N8/isolamento & purificação , Cooperação Internacional , Laboratórios/normas , Farmacopeias como Assunto/normas , Animais , Europa (Continente) , Feminino , Cavalos , Soros Imunes/genética , Soros Imunes/imunologia , Vírus da Influenza A Subtipo H3N8/genética , Vírus da Influenza A Subtipo H3N8/imunologia , Filogenia , Padrões de Referência , Estados Unidos
16.
Acta Med Hist Adriat ; 18(1): 89-104, 2020 06.
Artigo em Servo-Croata (Latino) | MEDLINE | ID: mdl-32638601

RESUMO

The paper presents a folk recipe collection manuscript written by an unknown author in Poljica area, in the 18th century. It is owned by the philologist, historian of literature and bibliophile, Josip Bratulic. Therefore, the author suggests that this recipe collection should bear the name Great folk medicine book from Poljica (Bratulic's folk medicine book). The manuscript is written in Latin script and Croatian language. It consists of 288 pages written in black ink and contains more than 1,100 recipes making it one of the largest known manuscripts. Although well preserved, a small part of it is unreadable. Most recommended recipes are for treating humans and domestic animals, while several recipes contain household tips. The abundance of its content, expressions, and healing instructions add this recipe collection to other similar manuscripts of this region, which create precious part of the Croatian medical, pharmaceutical, and cultural heritage.


Assuntos
Manuscritos Médicos como Assunto/história , Medicina Tradicional/história , Farmacopeias como Assunto/história , Croácia , História do Século XVIII
17.
Pharmacol Res ; 160: 105074, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32653649

RESUMO

PURPOSE: Traditional Chinese medicine (TCM) has fully engaged and played an essential role in the prevention and treatment of Coronavirus Disease 2019 (COVID-19). This study compares relevant standards on high-frequent Chinese Materia Medicia (CMM) used in this pandemic aiming at reaching a global consensus and ensuring the use of Chinese medicines safely. METHODS: 141 representative Chinese formulas and Chinese Patent Medicines from the National Protocol and the most of Provincial Protocols for controlling COVID-19 in China have been collected to statistical analyze the composition and characteristics of CMM. Among them, the domestic and international standards of 47 varieties with the frequency usage over 10 times were selected to compare their quality requirements in the mainstream pharmacopoeias and international standards. RESULTS: The quality requirements of used CMM for fighting COVID-19 on the terms of overall quality control, marker compounds, and safety indicators showed different patterns in these mainstream pharmacopoeias and international standards. The uniformed and scientific quality standards of CMM were urgently needed to promote global acceptation and trade. CONCLUSIONS: These findings will provide evidence for building unified quality and safety standards that can adapt to the characteristics of CMM and promote international trade, and also will be stated that it is of the highest priority for ISO/TC 249 to formulate high-quality standards that consolidate international consensus to ensure quality and safety of the urgently needed CMM.


Assuntos
Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/terapia , Medicamentos de Ervas Chinesas/normas , Medicamentos de Ervas Chinesas/uso terapêutico , Materia Medica/normas , Medicina Tradicional Chinesa/normas , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Pneumonia Viral/terapia , COVID-19 , Infecções por Coronavirus/tratamento farmacológico , Composição de Medicamentos , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Materia Medica/efeitos adversos , Materia Medica/uso terapêutico , Segurança do Paciente , Farmacopeias como Assunto , Saúde Pública , Controle de Qualidade
19.
Yakugaku Zasshi ; 140(6): 759-761, 2020.
Artigo em Japonês | MEDLINE | ID: mdl-32475923

RESUMO

In the Basic Principles for the Preparation of the Japanese Pharmacopoeia (JP), 18th edition, the JP is referred to as an official document that defines the specifications, criteria, and standard test methods necessary to properly ensure the quality of medicines in Japan and as a public property that should be widely used by all parties concerned, such as pharmaceutical administrations, companies, and those involved in research, education, and medical practice. In addition, it states that the JP should play an appropriate role of providing information and proper understanding of drug quality to the public and should promote and maintain advances, consistency, and harmonization of technical requirements in the international community. These show that the JP not only contributes as a written standard but also as a provider of information on test methods and international understanding for drug quality control. JP articles refer to a wide range of drugs at various phases of the product life cycle, as it should cover all drugs in terms of importance from the healthcare viewpoint. When the JP is viewed from a panoramic perspective, these are the reasons why its contents are extremely profound and complex. This report discusses the JP's role and expected future as a scientific document from the author's viewpoint as a JP Expert Committee member for more than 30 years.


Assuntos
Farmacopeias como Assunto , Serviços de Informação sobre Medicamentos , Japão , Farmacopeias como Assunto/normas , Controle de Qualidade
20.
Yakugaku Zasshi ; 140(6): 763-766, 2020.
Artigo em Japonês | MEDLINE | ID: mdl-32475924

RESUMO

The Japanese Pharmacopoeia (JP) is an official document that defines the specifications, criteria, and standard test methods necessary to properly ensure the quality of medicines in Japan. To ensure the efficacy and safety of pharmaceutical products, it is essential to establish standards that ensure their quality. For this purpose, the JP aims to include all drugs that are important from the viewpoint of healthcare and medical treatment, and description of each monograph of medicine is maintained and improved so that those standards can be generally practiced. In addition, to play a key role as the official document in the field of pharmaceutical product quality, JP contents are enhanced by proactively introducing the latest scientific knowledge and technologies. As the international manufacturing of pharmaceutical products and their raw materials that are distributed in Japan is increasing, the JP has recently begun to promote the international harmonisation of pharmaceutical excipients and general tests through the Pharmacopoeial Discussion Group (PDG) and to swiftly implement the harmonised items in the JP. In addition, the JP will implement internationally harmonised concepts and specifications for pharmaceutical products, e.g., the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to define the latest concepts of quality control for pharmaceutical products in the official document. We introduce the implementation of the latest scientific knowledge, technologies, and activities for international harmonisation of the JP.


Assuntos
Biofarmácia/normas , Cooperação Internacional , Conhecimento , Farmacopeias como Assunto , Humanos , Japão , Controle de Qualidade
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...