Análise comparativa do teor de diferentes marcas de vinagres comercializadas no Brasil frente ao especificado no rótulo

2020 ◽  
Vol 1 (3) ◽  
pp. 134-141
Author(s):  
Tacio Souza Lima ◽  
Leonardo Canuto Cappobianco ◽  
Vagner Santana Muslera ◽  
Thiago Borges Coelho ◽  
Aline Araujo dos Santos Viana ◽  
...  
Keyword(s):  
European Medicines Agency ◽  
Food And Drugs Administration

Os rótulos de produtos industrializados ao redor do mundo carregam consigo informações importantes sobre a segurança, eficácia e concentrações dos componentes contidos em sua formulação. Na maioria das vezes, essas informações são preconizadas em normas escritas por um grupo colegiado de entidades reguladoras tais como FDA (Food and Drugs Administration), MAPA (Ministério da Agricultura e Pecuária), ANVISA (Agência Nacional de Vigilância Sanitária) e EMA (European Medicines Agency). Existem especificações para medicamentos, cosméticos, produtos para saúde e alimentos que deveriam ser fiéis às características dos conteúdos presentes em seus rótulos. Em alguns casos, os desvios de concentrações podem acarretar em prejuízos à saúde e segurança de seus consumidores. Pensando nessa temática, alunos de graduação em farmácia da universidade Anhanguera Educacional escolheram 9 marcas de vinagres de uso alimentício comercializados no Brasil e analisaram suas concentrações por meio de técnica de titulométrica de ácido-base e compararam os resultados encontrados com os valores demostrados no rótulo de suas respectivas marcas. Os valores encontrados mostraram grande incidência de desvios quanto a concentração de CH3COOH (ácido acético) a 4g por100ml (4%). Pequenos desvios na concentração de alguns alimentos como é o caso do CH3COOH não produzem prejuízos a saúde, no entanto, quando especificados em rótulos os valores devem ser seguidos como medida de boas práticas de fabricação (BPF) e atendimento às normas vigentes.

scholarly journals D-Penicillamine: The State of the Art in Humans and in Dogs from a Pharmacological and Regulatory Perspective

Antibiotics ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. 648
Author(s):  
Michela Pugliese ◽  
Vito Biondi ◽  
Enrico Gugliandolo ◽  
Patrizia Licata ◽  
Alessio Filippo Peritore ◽  
...  
Keyword(s):  
Veterinary Medicine ◽  
State Of The Art ◽  
European Medicines Agency ◽  
Therapeutic Goals ◽  
First Choice ◽  
Regulatory Perspective ◽  
The World ◽  
United States Food ◽  
States Food ◽  
Food And Drugs Administration

Chelant agents are the mainstay of treatment in copper-associated hepatitis in humans, where D-penicillamine is the chelant agent of first choice. In veterinary medicine, the use of D-penicillamine has increased with the recent recognition of copper-associated hepatopathies that occur in several breeds of dogs. Although the different regulatory authorities in the world (United States Food and Drugs Administration—U.S. FDA, European Medicines Agency—EMEA, etc.) do not approve D-penicillamine for use in dogs, it has been used to treat copper-associated hepatitis in dogs since the 1970s, and is prescribed legally by veterinarians as an extra-label drug to treat this disease and alleviate suffering. The present study aims to: (a) address the pharmacological features; (b) outline the clinical scenario underlying the increased interest in D-penicillamine by overviewing the evolution of its main therapeutic goals in humans and dogs; and finally, (c) provide a discussion on its use and prescription in veterinary medicine from a regulatory perspective.

Independent Scientific Advice: Comparing Policies on Conflicts of Interest in the EU and the US

2011 ◽  
Vol 2 (2) ◽  
pp. 213-226 ◽  
Author(s):  
Simone Gabbi
Keyword(s):  
Food Safety ◽  
Conflict Of Interest ◽  
Conflicts Of Interest ◽  
European Food Safety Authority ◽  
European Medicines Agency ◽  
Scientific Advice ◽  
The Us ◽  
The One ◽  
Food And Drugs Administration ◽  
The Eu

This article highlights the importance of unbiased scientific advice in the European Union's legal system. It then analyses and compares the policies in force throughout the European Food Safety Authority, European Medicines Agency and European Commission's Scientific Committees with the one implemented by the US Food and Drugs Administration. The author argues that at the present time the framework adopted and implemented by the European Food Safety Authority seems to be the most complete and stringent amongst those taken into account in the article and he advances some proposals for further improvement of the policies regulating conflict of interest.

RTS,S/AS01, a vaccine targeting pre-erythrocytic stages of Plasmodium falciparum

2017 ◽  
Vol 1 (6) ◽  
pp. 533-537
Author(s):  
Lorenz von Seidlein ◽  
Borimas Hanboonkunupakarn ◽  
Podjanee Jittmala ◽  
Sasithon Pukrittayakamee
Keyword(s):  
Protective Efficacy ◽  
Age Groups ◽  
Sub Saharan Africa ◽  
Phase Iii ◽  
European Medicines Agency ◽  
Older Children ◽  
Pivotal Phase ◽  
Malaria Epidemiology ◽  
Maximum Benefit ◽  
Sub Saharan

RTS,S/AS01 is the most advanced vaccine to prevent malaria. It is safe and moderately effective. A large pivotal phase III trial in over 15 000 young children in sub-Saharan Africa completed in 2014 showed that the vaccine could protect around one-third of children (aged 5–17 months) and one-fourth of infants (aged 6–12 weeks) from uncomplicated falciparum malaria. The European Medicines Agency approved licensing and programmatic roll-out of the RTSS vaccine in malaria endemic countries in sub-Saharan Africa. WHO is planning further studies in a large Malaria Vaccine Implementation Programme, in more than 400 000 young African children. With the changing malaria epidemiology in Africa resulting in older children at risk, alternative modes of employment are under evaluation, for example the use of RTS,S/AS01 in older children as part of seasonal malaria prophylaxis. Another strategy is combining mass drug administrations with mass vaccine campaigns for all age groups in regional malaria elimination campaigns. A phase II trial is ongoing to evaluate the safety and immunogenicity of the RTSS in combination with antimalarial drugs in Thailand. Such novel approaches aim to extract the maximum benefit from the well-documented, short-lasting protective efficacy of RTS,S/AS01.

Wie sicher sind pädiatrische Arzneimittelverordnungen?

2007 ◽  
Vol 7 (06) ◽  
pp. 345-350 ◽  
Author(s):  
Martin Grimm ◽  
Corinna Gebauer ◽  
Thomas Kapellen ◽  
Oana Brosteanu ◽  
Wieland Kiess
Keyword(s):  
Vitamin K ◽  
European Medicines Agency ◽  
Off Label

ZusammenfassungHintergrund: Viele pädiatrisch eingesetzte Arzneimittel sind für Kinder nicht zugelassen. Der Mangel an Informationen zu Anwendung und Nebenwirkungen ist in der Frühgeborenen- und Intensivmedizin besonders hoch.Ziel: Das Ziel bestand in der Untersuchung des Zulassungsstatus der Medikamentenverordnungen an einer universitären Kinderklinik zur Priorisierung und Planung von Arzneimittelstudien.Material und Methoden: Auf einer interdisziplinären, einer neonatologischen Intensivstation und einer allgemeinpädiatrischen Station wurden über einen Zeitraum von 3 Monaten alle Arzneimittelverordnungen erfasst. Zur Analyse des Zulassungsstatus dienten die „Rote Liste®” und die Fachinformationen.Ergebnisse: 377 Patienten erhielten 2486 Verordnungen. Die häufigsten Arzneimittel waren Paracetamol, Vitamin K und Acetylcystein (ACC). Unlizensiert waren 5,5% aller Verordnungen; 39,5% wurden außerhalb der Altersgrenzen, 16,7% mit nicht zugelassener Indikation angewendet.Schlussfolgerung: Die unlizensierte und Off-Label-Arzneimittelanwendung ist noch weit verbreitet. Durch systematische Analysen können in Zusammenarbeit mit EMEA (European Medicines Agency) und PAED-Net Prioritätenlisten für Studien erstellt werden, die die Arzneimittelsicherheit erhöhen.

Alternativas farmacéuticas: ¿pueden ser intercambiables?

2020 ◽  
Vol 2 (2) ◽  
pp. 38-42
Author(s):  
Miriam del Carmen Carrasco-Portugal ◽  
Francisco Javier Flores-Murrieta
Keyword(s):  
Generic Substitution ◽  
In Vivo Studies ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Reference Formulation ◽  
Active Moiety ◽  
Significant Difference ◽  
Pharmaceutical Form ◽  
Extent Of Absorption

Pharmaceutical alternatives are products with the same active moiety, but different salt, ester or pharmaceutical form. Regulatory agencies have different criteria for this kind of drug. The European Medicines Agency (EMA) accepts the generic substitution using these alternatives, whereas the Food and Drug Administration (FDA) only authorizes generic substitution of pharmaceutical equivalents. The objective of this paper is to describe some relevant aspects that should be considered before deciding on making a generic substitution with pharmaceutical alternatives. It is important to note that a pharmaceutical alternative must show no significant difference in the rate and extent of absorption (bioequivalence) in a well-conducted in vivo study when compared with the reference formulation. Current Mexican regulations state that generic substitution is possible using pharmaceutical alternatives when bioequivalence is demonstrated in in vivo studies conducted under the NOM-177-SSA1-2013 criteria. In conclusion, generic substitution with pharmaceutical alternatives is possible if these products demonstrate in vivo bioequivalence when compared with the reference product.

Repurposing cilostazol for Raynaud's phenomenon

2020 ◽  
Vol 27 ◽  
Author(s):  
Nehme El-Hachem ◽  
Manal M. Fardoun ◽  
Hasan Slika ◽  
Elias Baydoun ◽  
Ali H. Eid
Keyword(s):  
Color Change ◽  
Angiotensin Receptor Blockers ◽  
Raynaud’S Phenomenon ◽  
Blood Perfusion ◽  
Raynaud's Phenomenon ◽  
Channel Blockers ◽  
Phosphodiesterase Type 5 Inhibitors ◽  
Receptor Blockers ◽  
Phosphodiesterase Type ◽  
Food And Drugs Administration

: Raynaud's Phenomenon (RP) results from exaggerated cold-induced vasoconstriction. RP patients suffer from vasospastic attacks and compromised digital blood perfusion leading to triple color change at the level the fingers. Severe RP may cause ulcers and threaten tissue viability. Many drugs have been used to alleviate the symptoms of RP. These include calcium-channel blockers, cGMP-specific phosphodiesterase type 5 inhibitors, prostacyclin analogs, and angiotensin receptor blockers. Despite their variety, these drugs do not treat RP but rather alleviate its symptoms. To date, no drug for RP has been yet approved by U.S Food and Drugs Administration. Cilostazol is a selective inhibitor of phosphodiesteraseIII, originally prescribed to treat intermittent claudication. Owing to its antiplatelet and vasodilating properties, cilostazol is being repurposed as a potential drug for RP. This review focuses on the different lines of action of action of cilostazol serving to enhance blood perfusion in RP patients.

Biosimilars of Adalimumab in Inflammatory Bowel Disease: Are we Ready for that?

2019 ◽  
Vol 25 (1) ◽  
pp. 7-12 ◽  
Author(s):  
Marjorie Argollo ◽  
Gionata Fiorino ◽  
Daniela Gilardi ◽  
Federica Furfaro ◽  
Giulia Roda ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Health Care Providers ◽  
Bowel Disease ◽  
Biological Treatment ◽  
Reference Product ◽  
European Medicines Agency ◽  
Care Providers ◽  
Inflammatory Bowel ◽  
To Receive ◽  
The Ideal

Introduction: Biosimilars present a considerable potential to reduce costs related to clinical management allowing health-care providers to reinvest this money, leading to a wider access to an effective biological treatment with monoclonal antibodies (mAb). Infliximab biosimilars have already been incorporated in daily clinical practice and are currently used in all indications for which the reference product (RP) was approved. Areas covered: In the next few years, also adalimumab biosimilars will become available for the treatment of inflammatory bowel disease (IBD). In fact, several of them (ABP501, BI 695501, GP2017, and SB5) have been approved by the European Medicines Agency (EMA) with the same indications of the reference product (Humira ®). Initial preclinical data proved a strong similarity between all biosimilars and the RP. Moreover, phase 3 studies in rheumatoid arthritis and psoriasis showed no differences in terms of efficacy, safety, and immunogenicity. Data on IBD patients are urgently needed. Expert opinion: Biosimilars of adalimumab showed equivalent clinical efficacy to the RP in other immunemediated diseases. However, defining the ideal patient’s profile to receive or to be switched to a biosimilar, choosing one biosimilar vs. another, or cross-switching among biosimilars, will become the next challenge in IBD.

Sign in / Sign up

Export Citation Format

Share Document