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1.
Psicol. Estud. (Online) ; 27: e48860, 2022.
Artigo em Português | LILACS, Index Psicologia - Periódicos | ID: biblio-1365269

RESUMO

RESUMO. As drogas se consolidam como um dos arquétipos culturais predominantes no cotidiano das sociedades urbanas, sendo sua presença ubíqua em praticamente todas as culturas. Os registros históricos apresentam ampla variabilidade de substâncias que em dado momento eram classificadas como o perigo social da época e que em outro se tornavam banalizadas ou tipificadas como inofensivas. Assim, esse estudo teve como objetivo analisar como dispositivo droga que se consolida em diferentes períodos históricos. Para isso, foram coletadas 4.227 matérias dos jornais Folha da Manhã, Folha da Noite e Folha de São Paulo, que abordassem questões relativas ao álcool (década de 1920), maconha (décadas de 1930 a 1960) e crack (década de 1980 a 2005) e realizada Análise Temática de Conteúdo. Os resultados permitem afirmar que a característica central que define todas as substâncias analisadas nos distintos momentos históricos é o risco social que ela apresenta. A droga se constitui como um risco aos usuários ao mesmo tempo que os institui enquanto uma figura de ameaça social. Ao se referenciar uma substância como uma droga, são ativados sentidos que remetem a um quadro de decadência e criminalidade.


RESUMEN. Las drogas se consolidan como uno de los arquetipos culturales predominantes en la vida cotidiana de las sociedades urbanas, y su presencia ubicua en prácticamente todas las culturas. Los registros históricos muestran una amplia variabilidad de sustancias que en un momento se clasificaron como el peligro social de la época y en otro momento se trivializaron o tipificaron como inofensivas. Así que este estudio tuvo como objetivo analizar cómo diferentes sustancias psicoactivas se encuentran en la prensa como un riesgo social en diferentes momentos. Para ello, se recogieron 4.227 artículos del periódico Folha da Manhã, Folha da Noite y Folha de São Paulo, que abordasen temas relacionados con el alcohol (1920), marihuana (1930 a 1960) y el crack (1980 a 2005) y se realizó un Análisis Temático de Contenido. Los resultados muestran que la característica definitoria de todas las drogas examinadas en los diferentes momentos históricos es el riesgo social que presenta. La droga se constituye como un riesgo para los usuarios mientras los establece como una figura de amenaza social. Al hacer referencia a una sustancia como droga, se activan sentidos que conducen a un marco de decadencia y criminalidad.


ABSTRACT Drugs are one of the predominant cultural archetypes in the daily life of urban societies, and their ubiquitous presence in almost all cultures. Historical records show a wide variability of substances that at one point were classified as the social danger of the time and at another time trivialized or typified as harmless. Thus, this study aimed to analyze how different psychoactive substances are constituted in the press as a social risk at different times. For this, we collected 4,227 articles of newspapers Folha da Manhã, Folha da Noite and Folha de São Paulo, that addressed issues related to alcohol (1920), marijuana (1930s to 1960) and crack (1980s to 2005) and performed a Thematic Content Analysis. The results indicate that the central defining characteristic of all drugs examined in the different historical moments is the social risk it has. The drug is constituted as a risk to users while establishing them as a figure of social threat. When referring a substance as a drug, senses are activated that denote to a situation of decadence and crime.


Assuntos
Cannabis , Preparações Farmacêuticas/história , Cocaína Crack/análise , Alcoolismo , Meios de Comunicação de Massa , Psicotrópicos/análise , Apoio Social , Usuários de Drogas/psicologia , Comportamento Criminoso/efeitos dos fármacos
2.
Pharmazie ; 76(2): 119-125, 2021 02 25.
Artigo em Inglês | MEDLINE | ID: mdl-33714290

RESUMO

The paper explores the beginnings of pharmaceutical industry development in Croatia and the establishment of the first pharmaceutical factory in Southeast Europe. Adolf Thierry de Chateauvieux (St. Pölten, 1854 - Pregrada, 1920), a nobleman hailing from France, immigrated to Croatia at the end of the 19 th century. He bought the Angjelu cuvaru ( Guardian Angel ) pharmacy (1892) in the small town of Pregrada and established the first pharmaceutical factory (1894) in this part of Europe. The factory had an equipped laboratory, a production facility, a storage room for raw materials and balsams, a room for packaging and shipping finished products and a commercial office. Production was mainly based on herbal remedies. The most famous were Thierry's Balsam and Thierry's Centifolia Ointment, both registered and patented in London (1900). By virtue of Adolf Thierry's entrepreneurial spirit and skilful product advertisement, his medicinal preparations were distributed across Europe, America, India and Africa, a testament to which is the well-preserved and researched documentation.


Assuntos
Indústria Farmacêutica/história , Preparações Farmacêuticas/história , Croácia , Europa (Continente) , Medicina Herbária , História do Século XVIII , Humanos , Medicina do Trabalho/história
3.
Arch Dis Child ; 106(7): 631-635, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33419728

RESUMO

Rational prescribing of medicines requires evidence from clinical trials on efficacy, safety and the dose to be prescribed, based on clinical trials. Regulatory authorities assess these data and information is included in the approved summary of product characteristics. Regulatory guidelines on clinical investigation of medicinal products in the paediatric population generally propose that studies are done in defined age groups but advise that any classification of the paediatric population into age categories is to some extent arbitrary or that the age groups are intended only as a guide. The pharmaceutical companies tend to plan their studies using age groups the regulatory guidelines suggest, to avoid problems when applying for marketing authorisation. These age bands end up in the paediatric label, and consequently into national paediatric formularies. The age bands of the most commonly used age-subsets: neonates, infant/toddlers, children and adolescents, are more historical than based on physiology or normal development of children. Particularly problematic are the age bands for neonates and adolescents. The age of 12 years separating children from adolescents, and the upper limit of the adolescents set by the definition of paediatric age in healthcare, which varies according to the region, are particularly questionable. Modern pharmacometric methods (modelling and simulation) are being increasingly used in paediatric drug development and may allow assessment of growth and/or development as continuous covariables. Maybe time has come to reconsider the rational of the currently used age bands.


Assuntos
Aprovação de Drogas/legislação & jurisprudência , Indústria Farmacêutica/ética , Legislação de Medicamentos/estatística & dados numéricos , Preparações Farmacêuticas/história , Adolescente , Fatores Etários , Criança , Pré-Escolar , Desenvolvimento de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Rotulagem de Medicamentos/legislação & jurisprudência , Rotulagem de Medicamentos/estatística & dados numéricos , Prescrições de Medicamentos , Guias como Assunto , História do Século XIX , Humanos , Lactente , Recém-Nascido
4.
J Med Toxicol ; 17(2): 197-217, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33140232

RESUMO

INTRODUCTION: Medications are compounded when a formulation of a medication is needed but not commercially available. Regulatory oversight of compounding is piecemeal and compounding errors have resulted in patient harm. We review compounding in the United States (US), including a history of compounding, a critique of current regulatory oversight, and a systematic review of compounding errors recorded in the literature. METHODS: We gathered reports of compounding errors occurring in the US from 1990 to 2020 from PubMed, Embase, several relevant conference abstracts, and the US Food and Drug Administration "Drug Alerts and Statements" repository. We categorized reports into errors of "contamination," suprapotency," and "subpotency." Errors were also subdivided by whether they resulted in morbidity and mortality. We reported demographic, medication, and outcome data where available. RESULTS: We screened 2155 reports and identified 63 errors. Twenty-one of 63 were errors of concentration, harming 36 patients. Twenty-seven of 63 were contamination errors, harming 1119 patients. Fifteen errors did not result in any identified harm. DISCUSSION: Compounding errors are attributed to contamination or concentration. Concentration errors predominantly result from compounding a prescription for a single patient, and disproportionately affect children. Contamination errors largely occur during bulk distribution of compounded medications for parenteral use, and affect more patients. The burden falls on the government, pharmacy industry, and medical providers to reduce the risk of patient harm caused by compounding errors. CONCLUSION: In the US, drug compounding is important in ensuring access to vital medications, but has the potential to cause patient harm without adequate safeguards.


Assuntos
Composição de Medicamentos/história , Contaminação de Medicamentos/legislação & jurisprudência , Contaminação de Medicamentos/estatística & dados numéricos , Indústria Farmacêutica/história , Indústria Farmacêutica/legislação & jurisprudência , Legislação de Medicamentos/história , Preparações Farmacêuticas/história , História do Século XX , História do Século XXI , Humanos , Estados Unidos
5.
Hist Cienc Saude Manguinhos ; 26(4): 1121-1137, 2019.
Artigo em Espanhol, Inglês | MEDLINE | ID: mdl-31800831

RESUMO

In the late nineteenth century, as in other regions of Argentina and Latin America, the Santa Fe press featured a growing number of offers of health products such as tonics, pills and syrups. Aimed at a lay audience, these claimed to cure a series of conditions defined as belonging to "modern life." This article analyzes the discursive dimension of the advertisements printed between 1890 and 1918: how they organized meanings associated with these conditions, an issue that is inscribed within a broad line of research aimed at analyzing social representations of health and disease, and how they participated in the different social spheres in the constitution of modern-day Argentina.


A fines del siglo XIX, en consonancia con otras regiones de Argentina y Latinoamérica, en la prensa santafesina se incrementó la oferta de productos para la salud como tónicos, pastillas y jarabes. Ofrecidos a un público no experto, prometían curar una serie de dolencias que definían como propias "de la vida moderna". El artículo analiza la dimensión discursiva de los avisos publicitarios aparecidos entre 1890 y 1918: cómo organizaron los sentidos sobre estas dolencias, interrogante que se inscribe en una amplia línea de estudios abocada a analizar las representaciones sociales sobre la salud y la enfermedad y cómo éstas participaron en las distintas esferas sociales en la constitución de la Argentina moderna.


Assuntos
Publicidade/história , Marketing de Serviços de Saúde/história , Jornais como Assunto/história , Preparações Farmacêuticas/história , Argentina , Feminino , História do Século XIX , História do Século XX , Humanos , Masculino , Publicações Periódicas como Assunto/história , Médicos/história
6.
Hist. ciênc. saúde-Manguinhos ; 26(4): 1121-1137, out.-dez. 2019.
Artigo em Espanhol | LILACS | ID: biblio-1056267

RESUMO

Resumen A fines del siglo XIX, en consonancia con otras regiones de Argentina y Latinoamérica, en la prensa santafesina se incrementó la oferta de productos para la salud como tónicos, pastillas y jarabes. Ofrecidos a un público no experto, prometían curar una serie de dolencias que definían como propias "de la vida moderna". El artículo analiza la dimensión discursiva de los avisos publicitarios aparecidos entre 1890 y 1918: cómo organizaron los sentidos sobre estas dolencias, interrogante que se inscribe en una amplia línea de estudios abocada a analizar las representaciones sociales sobre la salud y la enfermedad y cómo éstas participaron en las distintas esferas sociales en la constitución de la Argentina moderna.


Abstract In the late nineteenth century, as in other regions of Argentina and Latin America, the Santa Fe press featured a growing number of offers of health products such as tonics, pills and syrups. Aimed at a lay audience, these claimed to cure a series of conditions defined as belonging to "modern life." This article analyzes the discursive dimension of the advertisements printed between 1890 and 1918: how they organized meanings associated with these conditions, an issue that is inscribed within a broad line of research aimed at analyzing social representations of health and disease, and how they participated in the different social spheres in the constitution of modern-day Argentina.


Assuntos
Humanos , Masculino , Feminino , História do Século XIX , História do Século XX , Preparações Farmacêuticas/história , Marketing de Serviços de Saúde/história , Publicidade/história , Jornais como Assunto/história , Publicações Periódicas como Assunto/história , Argentina , Médicos/história
8.
Bull Hist Med ; 91(2): 362-390, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28757500

RESUMO

This article explores the role of testing in the allocation of royal monopoly privileges for drugs in eighteenth-century France by following the multi-generational fortunes of a single "secret remedy" from 1713 to 1776: the poudre fébrifuge of the Chevalier de Guiller. On at least five occasions, this drug was tested on patients in order to decide whether it should be protected by a privilege and whether or not its vendors should be awarded lucrative contracts to supply it in bulk to the French military. Although efforts were made early in the century to test the drug through large-scale hospital trials and to relegate privilege granting to a bureaucratic commission, the case of the poudre fébrifuge instead suggests that military expediency and relatively small-scale trials administered personally by royal practitioners remained decisive in determining whether or not a drug received a monopoly privilege or a military contract.


Assuntos
Serviços Contratados/história , Indústria Farmacêutica/história , Militares , Preparações Farmacêuticas/história , Tecnologia Farmacêutica/história , Contratos , Indústria Farmacêutica/organização & administração , França , História do Século XVIII , Humanos , Farmácia
10.
Br J Hist Sci ; 49(4): 577-600, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27881189

RESUMO

The attitudes of physicians and drug manufacturers in the US toward patenting pharmaceuticals changed dramatically from the mid-nineteenth century to the mid-twentieth. Formerly, physicians and reputable manufacturers argued that pharmaceutical patents prioritized profit over the advancement of medical science. Reputable manufactures refused to patent their goods and most physicians shunned patented products. However, moving into the early twentieth century, physicians and drug manufacturers grew increasingly comfortable with the idea of pharmaceutical patents. In 1912, for example, the American Medical Association dropped the prohibition on physicians holding medical patents. Shifts in wider patenting cultures therefore transformed the ethical sensibilities of physicians.


Assuntos
Ética Médica/história , Patentes como Assunto/história , Preparações Farmacêuticas/história , American Medical Association/história , Comércio/ética , Comércio/história , História do Século XIX , História do Século XX , Patentes como Assunto/ética , Preparações Farmacêuticas/economia , Estados Unidos
11.
Theriaca ; (43): 9-61, 2016.
Artigo em Dinamarquês | MEDLINE | ID: mdl-27491172

RESUMO

The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 8 deals with products from Lundbeck. Lundbeck which today is known as a considerable international pharmaceutical company could in 2015 celebrate its 100 years' jubilee. Among the early Danish medicinal companies H. Lundbeck & Co. is in many ways an exception as the company was not originally established as a pharmaceutical company. Not until several years after the foundation the company began to import foreign ready-made medicinal products and later-on to manufacture these medicinal products in own factory and even later to do research and development of own innovative products. When Lundbeck was established in 1915 several Danish medicinal companies, not only the well-known such as Alfred Benzon and Løvens kemiske Fabrik (LEO Pharma), but also Skelskør Frugtplantage, Ferrin and Ferraton, had emerged due to the respective enterprising pharmacy owners who had expanded their traditional pharmacy business and even with commercial success. Other medicinal companies, such as C.R. Evers & Co., Leerbeck & Holms kemiske Fabriker, Chr. F. Petri, Erslevs kemiske Laboratorium, Edward Jacobsen, Th. Fallesen-Schmidt, and yet other companies which were named after the founder had all been established by pharmacists with the primary intention to manufacture and sell medicinal products. Also for the limited companies Medicinalco, Ferrosan, Pharmacia, and GEA the primary task was to manufacture and sell medicinal products, and also in these companies pharmacists were involved in the foundation. Not until 1924, fully 9 years after the foundation, Lundbeck started to be interested in medicinal products and initiated import and sale of foreign medicinal products manufactured by a.o. German and French companies which had not established their own sales companies in Denmark. Almost all contemporary Danish manufacturers of medicinal products could exclusively determine own proprietary names of the articles and could themselves make their own homogeneous and easily recognisable design, a.o. by frequent use of prefixes as Afa, Asa, Gea, Ido, Leo, and Meco which associated to for instance the company name. However, it goes without saying that Lundbeck had to market the articles in commission according to the different contracts with their partners. Consequently their range of products appeared heterogeneously. The international financial crisis and the consequent unemployment in the 1920s and 1930s had in Denmark a.o. resulted in national regulation in order to complicate import of ready-made goods and thus support the domestic manufacture of such articles. This was one of the reasons why Lundbeck decided to initiate its own manufacture of medicinal products in Denmark instead of continuing only with the import business which had been obstructed by the authorities. This article does not mention all Lundbeck's medicinal products which were marketed in Denmark until 1955 where a new Pharmacy Act came into force though undoubtedly a lot of interest can be written about all of them. The products mentioned in this article have been carefully selected, not only because they are representative for Lundbeck's development during the first decades, but also because the Danish Collection of the History of Pharmacy has acquired consumer packages of many of the articles. Several of these packages include patient information leaflets with an instruction for use and/or other information, and especially these leaflets represent a source material which has not previously been given much attention. It does not appear from the available source material whether these earliest medicinal products from Lundbeck were assembled in Danish packages on the production sites, or whether they were repacked in Copenhagen. It is not unlikely that the assembling originally was finalized abroad, and that instructions for the production of packaging material with Danish text were supplied by Lundbeck to the respective manufacturers. However, it is not unlikely either that the currency restrictions which were made after 1932 encouraged Lundbeck, where possible, first of all to import raw materials and bulk products and then manufacture the finished products in Valby. This was the case with Anusol, which Lundbeck certainly emphazised in the advertisement. It has to be pointed out that at that time there were no legal requirements regarding dating, neither of the user instructions nor of advertisements. Thus it is not due to mistakes or omissions made by Lundbeck that these materials are undated. The user instructions which Lundbeck had inserted in the packages were made and distributed at a time where no legal restrictions were in force neither regarding form nor content of such. The user instructions for products marketed after 1932 had probably been presented to the Pharmacopoeia Commission as this was statutory. It is, however, uncertain whether the Commission has dealt with the contents and the look of the user instructions. The most important task of the Commission was besides of the work with maintaining the Pharmacopoeia to look after the economic interests of the pharmacies so that only new drug substances could be marketed by the pharmaceutical industry, cf. below. In order to find out whether, and if so to which extent, the Pharmacopoeia Commission has been occupied in evaluating the informative and promoting printed matters of the industry, would require studies of the unprinted files of the Commission, and that is outside the scope of this article. At that time it was not against the law to inform in a user instruction that in case of a longer period of treatment, it would be more economical for the patient to buy a larger package. If you look at these patient information leaflets with today's eyes in the light of the present detailed, comprehensive and rigid regulations which the EU Commission has stated regarding patient information leaflets, you will find that Lundbeck's patient information leaflets were both simple and easy to read. On a free sample of Gelonida meant for the prescribing physician Lundbeck stated, besides of indication, dosage and warnings, also that the article was "Manufactured in Denmark". At that time it was not required to print information of production sites on packaging materials, however, it was not unusual to use this sales promoting claim in times of unemployment. In 1949 the original packaging material for Beatin was modified because certain text elements, the therapeutic indications were removed as it appeared that they since 1933 had violated the Pharmacy Act against advertisements for medicinal products aimed at the public. The packaging material for Beatin is a model example of the possibilities to combine practical information about the use of a medicinal product with sales claims in a reliable way. The above text modification and thus the legalisation of the packaging material took place upon request from the company as the violation of the advertising rules of the Pharmacy Act apparently had not resulted in any legal problems. Studies of unpublished files from the National Board of Health may possibly explain the background of this sequence of events, however, that is outside the scope of this article. The paragraph of the Pharmacy Act of 1932, stating that a medicinal product containing a common commodity as the active ingredient could not be marketed as a proprietary medicinal product, was meant to protect the pharmacies against the increasing competition from the industry. At first the paragraph did put a strain on the industry which from then on either had to manufacture own originator products or to copy other originator products without breaking patents. In the long run it has probably caused that not only Lundbeck, but also other Danish pharmaceutical companies became research-oriented and thus have been able to develop a relatively large number of originator products. In this context a product like Lucamid can hardly be regarded as an example of such a compulsory development of an originator product, an acetylsalicylic acid analogue. There were already such products on the market, but the wish to develop a better active ingredient has probably been bigger. From the three first editions of The Tariff of Medicines from 1935, 1937 and 1939 respectively it appears how Lundbeck's business within the area of medicines developed during the last half of the 1930s. In 1935 Lundbeck had placed 36 different medicinal products on the market, and all of them were in-licensing products. 4 years later, in 1939 Lundbeck had placed 40 different medicinal products on the market, and the number of in-licensing products had been reduced to 18 and 22 products were Lundbeck products. However, the increased focus on the development of own new medicinal products as Epicutan and Klianyl did not stop the in-licensing activities. Varex which Lundbeck brought on the market in 1942 came from a German pharmaceutical company with which Lundbeck had not previously collaborated. In Denmark Lundbeck had the intention to market 4 of Goedecke's 6 different medicinal products which all had Gelonida as part of the proprietary name. However, only one of these products got a longer life and with a simplified name, namely Gelonida. The fixed combination with three compounds of acetylsalicylic acid, phenacetin and codeine was without doubt effective, however, already at the end of the 1950s concern was raised about the safety of phenacetin. The Card Index of Medicines is a primary source of knowledge of how Lundbeck marketed the earliest medicinal products to the prescribing physicians. (ABSTRACT TRUNCATED)


Assuntos
Indústria Farmacêutica/história , História da Farmácia , Preparações Farmacêuticas/história , Dinamarca , Indústria Farmacêutica/organização & administração , História do Século XX , Marketing/história , Pesquisa/história , Tecnologia Farmacêutica/história
13.
Regul Toxicol Pharmacol ; 79 Suppl 1: S11-8, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27267171

RESUMO

Historically, pharmaceutical industry regulatory guidelines have assigned certain active pharmaceutical ingredients (APIs) to various categories of concern, such as "cytotoxic", "hormones", and "steroids". These categories have been used to identify APIs requiring segregation or dedication in order to prevent cross-contamination and protect the quality and safety of drug products. Since these terms were never defined by regulatory authorities, and many novel pharmacological mechanisms challenge these categories, there is a recognized need to modify the historical use of these terms. The application of a risk-based approach using a health-based limit, such as an acceptable daily exposure (ADE), is more appropriate for the development of a Quality Risk Management Program (QRMP) than the use of categories of concern. The toxicological and pharmacological characteristics of these categories are discussed to help identify and prioritize compounds requiring special attention. Controlling airborne concentrations and the contamination of product contact surfaces in accordance with values derived from quantitative risk assessments can prevent adverse effects in workers and patients, regardless of specific categorical designations to which these APIs have been assigned. The authors acknowledge the movement away from placing compounds into categories and, while not yet universal, the importance of basing QRMPs on compound-specific ADEs and risk assessments. Based on the results of a risk assessment, segregation and dedication may also be required for some compounds to prevent cross contamination during manufacture of APIs.


Assuntos
Contaminação de Medicamentos/prevenção & controle , Indústria Farmacêutica , Nível de Efeito Adverso não Observado , Exposição Ocupacional/prevenção & controle , Saúde Ocupacional , Preparações Farmacêuticas , Animais , Indústria Farmacêutica/história , Indústria Farmacêutica/legislação & jurisprudência , Indústria Farmacêutica/normas , Guias como Assunto , Política de Saúde , História do Século XXI , Humanos , Exposição Ocupacional/efeitos adversos , Exposição Ocupacional/legislação & jurisprudência , Exposição Ocupacional/normas , Saúde Ocupacional/história , Saúde Ocupacional/legislação & jurisprudência , Saúde Ocupacional/normas , Preparações Farmacêuticas/classificação , Preparações Farmacêuticas/história , Preparações Farmacêuticas/normas , Formulação de Políticas , Controle de Qualidade , Medição de Risco , Testes de Toxicidade
14.
Regul Toxicol Pharmacol ; 79 Suppl 1: S28-38, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27233926

RESUMO

This manuscript discusses the different historical and more recent default approaches that have been used to derive an acceptable daily exposure (ADE). While it is preferable to derive a health-based ADE based on a complete nonclinical and clinical data package, this is not always possible. For instance, for drug candidates in early development there may be no or limited nonclinical or clinical trial data. Alternative approaches that can support decision making with less complete data packages represent a variety of methods that rely on default assumptions or data inputs where chemical-specific data on health effects are lacking. A variety of default approaches are used including those based on certain toxicity estimates, a fraction of the therapeutic dose, cleaning-based limits, the threshold of toxicological concern (TTC), and application of hazard banding tools such as occupational exposure banding (OEB). Each of these default approaches is discussed in this manuscript, including their derivation, application, strengths, and limitations. In order to ensure patient safety when faced with toxicological and clinical data-gaps, default ADE methods should be purposefully as or more protective than ADEs derived from full data packages. Reliance on the subset of default approaches (e.g., TTC or OEB) that are based on toxicological data is preferred over other methods for establishing ADEs in early development while toxicology and clinical data are still being collected.


Assuntos
Indústria Farmacêutica , Nível de Efeito Adverso não Observado , Exposição Ocupacional/prevenção & controle , Saúde Ocupacional , Preparações Farmacêuticas , Testes de Toxicidade/métodos , Animais , Relação Dose-Resposta a Droga , Indústria Farmacêutica/história , Indústria Farmacêutica/legislação & jurisprudência , Indústria Farmacêutica/normas , Guias como Assunto , Política de Saúde , História do Século XX , História do Século XXI , Humanos , Dose Letal Mediana , Exposição Ocupacional/efeitos adversos , Exposição Ocupacional/legislação & jurisprudência , Exposição Ocupacional/normas , Saúde Ocupacional/história , Saúde Ocupacional/legislação & jurisprudência , Saúde Ocupacional/normas , Preparações Farmacêuticas/classificação , Preparações Farmacêuticas/história , Preparações Farmacêuticas/normas , Formulação de Políticas , Reprodutibilidade dos Testes , Medição de Risco , Testes de Toxicidade/história , Testes de Toxicidade/normas
15.
Bull Hist Med ; 90(1): 61-91, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27040026

RESUMO

This article analyzes why adulteration became a key trope of the Indian drug market. Adulteration had a pervasive presence, being present in medical discourses, public opinion and debate, and the nationalist claim for government intervention. The article first situates the roots of adulteration in the composite nature of this market, which involved the availability of drugs of different potencies as well as the presence of multiple layers of manufacturers, agents, and distributors. It then shows that such a market witnessed the availability of drugs of diverse potency and strengths, which were understood as elements of adulteration in contemporary medical and official discourse. Although contemporary critics argued that the lack of government legislation and control allowed adulteration to sustain itself, this article establishes that the culture of the dispensation of drugs in India necessarily involved a multitude of manufacturer-retailers, bazaar traders, and medical professionals practicing a range of therapies.


Assuntos
Colonialismo/história , Marketing de Serviços de Saúde/história , Ayurveda/história , Preparações Farmacêuticas/história , História do Século XX , Índia , Preparações Farmacêuticas/economia
16.
Rev Hist Pharm (Paris) ; 63(388): 399-422, 2015 Dec.
Artigo em Francês | MEDLINE | ID: mdl-26827550

RESUMO

For several convergent reasons, 1915 was a key period for the pharmaceutical industry in France. The overall realization that France was dependent on Germany for chemical and pharmaceutical products came from shortages of key drugs but also from massive use of poison gas for which France was not able to face this unexpected event. France's shortage for chemists properly trained to answer the needs of industry, the weak relationship between industry and faculty, the uncomfortable situation of specialty drugs, the regulations on patents and trademarks were many subjects of controversies which will contribute to the analysis of the source of this French dependence to Germany. It will be at the origin of new orientations after the war for the pharmaceutical industry and the French society. The objective was to be independent for drugs and consequently to resolve the identified issues, as well as to have a dynamic industrial research. The creation and development of several pharmaceutical companies after the war was a more or less direct benefit from the considerations starting in 1915.


Assuntos
Indústria Farmacêutica/história , Preparações Farmacêuticas/história , Pesquisa/história , França , Alemanha , História do Século XIX , História do Século XX , Humanos , Preparações Farmacêuticas/provisão & distribuição
17.
Med Hist ; 59(1): 44-62, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25498437

RESUMO

This article outlines the history of the commerce in medicinal plants and plant-based remedies from the Spanish American territories in the eighteenth century. It maps the routes used to transport the plants from Spanish America to Europe and, along the arteries of European commerce, colonialism and proselytism, into societies across the Americas, Asia and Africa. Inquiring into the causes of the global 'spread' of American remedies, it argues that medicinal plants like ipecacuanha, guaiacum, sarsaparilla, jalap root and cinchona moved with relative ease into Parisian medicine chests, Moroccan court pharmacies and Manila dispensaries alike, because of their 'exotic' charisma, the force of centuries-old medical habits, and the increasingly measurable effectiveness of many of these plants by the late eighteenth century. Ultimately and primarily, however, it was because the disease environments of these widely separated places, their medical systems and materia medica had long become entangled by the eighteenth century.


Assuntos
Comércio/história , Fitoterapia/história , Plantas Medicinais , Colonialismo/história , História do Século XVIII , História do Século XIX , Humanos , Preparações Farmacêuticas/economia , Preparações Farmacêuticas/história , América do Sul
19.
Med Secoli ; 26(2): 537-74, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-26054214

RESUMO

Between 1944 and 1989--the period of communist power in Poland--the national pharmaceutical market experienced several dramatic changes. The country was a prodigious importer of drugs following the Second World War, with a large portion of the medicine received being donated by various aid organisations. In the 1960s, Poland became a significant exporter of drugs to the Eastern Bloc countries, but dropped down the list of meaningful producers again after the post-1989 transformation. For four and a half decades the pharmaceutical market in Poland had been a scene of political and ideological struggle. The companies, owned and controlled by the state, were poorly managed, being neither innovative nor competitive. This fact, along with the state's irrational and inconsequent drug policy, caused an almost permanent shortage in drug supplies for patients: ironic for a socialist system in which universal and free health care was a basic principle.


Assuntos
Indústria Farmacêutica/história , Preparações Farmacêuticas/história , Comunismo , História do Século XX , Preparações Farmacêuticas/provisão & distribuição , Polônia
20.
Theriaca ; (42): 9-30, 2014.
Artigo em Dinamarquês | MEDLINE | ID: mdl-25816560

RESUMO

The article series provides a written and pictorial account of the Danish pharmaceutical industry's products from their introduction until about 1950. Part 6 deals with products from A/S Pharmacia. A/S Pharmacia was established in Copenhagen in 1922 as a Danish limited company by the enterprising pharmacist Edward Jacobsen. Pharmacia was not Jacobsen's first pharmaceutical company as previously he had established a pharmaceutical agency already in 1913 which in 1919 was reorganized to a limited company by the name of A/S Edward Jacobsen. This agency was later extended to include a production of generics. Jacobsen remained the co-owner and manager of Pharmacia until 1934 where he resigned and established another company, A/S Ejco, for the manufacture of generics. It is worth mentioning that already in 1911 a Swedish pharmaceutical company was established named AB Pharmacia. Today we do not know whether Edward Jacobsen knew about this Swedish company. Later on in 1936 AB Pharmacia and A/S Pharmacia made a contract concerning mutual market sharing, and a research cooperation was brought about between the two companies which resulted in an increase of turnover for A/S Pharmacia. In 1955 the cooperation between the two companies was increased as the Swedish company joined as principal shareholder with the purpose of continuing and developing the Danish company as an independent pharmaceutical company with its own research and development as well as manufacture, control and marketing. Therefore Pharmacia in Denmark was able to establish a synthesis factory in Koge and move the domicile to new premises in Hillered. In 1993 Pharmacia was presented in a printed matter as "The largest Nordic pharmaceutical company" as a result of the merger between the Swedish Kabi Pharmacia, formerly established by a merger between Kabi Vitrum and AB Pharmacia, and the Italian Farmitalia Carlo Erba. Only two years later in 1995 Pharmacia merged with the American pharmaceutical company The Upjohn Company under the name of Pharmacia & Upjohn. In 2000 this company was merged with the chemical group Monsanto under a new name, Pharmacia Corporation. Pharmacia Corporation was taken over by Pfizer in 2003. The early activities of A/S Pharmacia included not only the import of raw materials and ready-made articles, such as medicinal products, but also the manufacture of own medicinal products. This is not surprising considering the founder Edward Jacobsen's pharmaceutical career. Pharmacia's early manufacture of own medicinal products consisted mainly of generics, however, not only the expensive foreign medicinal products, but also any available Danish generics such as easily manufactured pharmacopeia products. It is thus worth mentioning that Pharmacia's own technological production capacity at that time was limited and required a cooperation with other (Danish) pharmaceutical companies. Pharmacia was able to produce tablet cores, but the sugarcoating had to be made by external business partners. Pharmacia was able to produce digitalis preparations, but the standardization of these had to be effected elsewhere. The total production of one of Pharmacia's products took place at an external business partner. Pharmacia was established at a time where the increasing use of industrially manufactured medicinal products, both Danish and foreign ones, had resulted in a considerable decrease in sales of pharmacy produced medicinal products. This had for a long time worried The Danish Association of Pharmacies, and this resulted in a reaction from the association, namely the DAK-products which by nature were produced in Denmark and thus became the most essential element in the fight against the industrially manufactured products--a fight which according to the association had to be fought with all legal means. Therefore The Danish Association of Pharmacies obviously reacted precipitated when in 1926 the association in writing stated that Pharmacia's products were not manufactured in Denmark in spite of the fact that they were labelled as such according to agreement with Landsforeningen Dansk Arbejde, i.e., The National Association Danish Work, which in 1925 allowed Pharmacia to use the labels of the association. The unemployment was high in the 1920'ies and increasing so when Pharmacia subsequently took legal action against the Association of Pharmacies and claimed that the statement was unjustified and might harm Pharmacia, it may indicate that the public of that time looked positively upon the manufacture and the use of Danish manufactured products. The Danish Association of Pharmacies lost the case as the claim according to the court was unjustified and thus unlawful. The suspicions of the association were not supported by facts, however, they were not either completely groundless. Following this The National Association Danish Work gave notice to terminate the contract with Pharmacia concerning the right to use the labels of the association. By expanding the cooperation and later on by merging with the Swedish Pharmacia AB the Danish A/S Pharmacia succeeded in continuing and developing a company where research, development and production of innovative medicinal products as well as of generics could take place in Denmark.


Assuntos
Indústria Farmacêutica/história , Preparações Farmacêuticas/história , Dinamarca , Indústria Farmacêutica/organização & administração , História do Século XX , História do Século XXI , Pesquisa/história , Tecnologia Farmacêutica/história
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