26 documents found, page 1 of 3
Recomendações sobre manipulação de anticorpos monoclonais em oncologia: propost...
Cardoso, Catarina; Henriques, Inês; Santos, Marlene; Moreira, FernandoEnquadramento: Existem diversas opções terapêuticas disponíveis para o tratamento do cancro, tais como a imunoterapia com recurso a anticorpos monoclonais (MAb) [1]. Por forma a garantir-se a correta manipulação dos MAb, reveste-se de particular importância a consulta de diretrizes e dos próprios resumos de características dos medicamentos (RCM). Uma diretriz consiste num conjunto de declarações, orientações ou...
In vitro studies into establishing therapeutic bioequivalence of complex topica...
Miranda, Margarida; Volmer, Zoe; Cornick, Alicia; Goody, Aidan; Cardoso, Catarina; Pais, Alberto; Brown, Marc; Vitorino, CarlaOver the past decade, topically applied drug products have experienced extraordinary price increases, due to the shortage of multisource generic drug products. This occurrence is mainly related to the underlying challenges evolved in topical bioequivalence documentation. Although there has been continuing regulatory efforts to present surrogate in vitro methods to clinical endpoint studies, there is still a con...
Manipulação de anticorpos monoclonais em tratamentos oncológicos: revisão siste...
Cardoso, Catarina; Henriques, Inês; Santos, Marlene; Moreira, Fernando; Moreira, Fernando; Santos, MarleneEm 2020, a incidência de cancro foi de 19,3 milhões de casos em todo o Mundo. Em 2040 perspetiva-se um aumento para 28,4 milhões de novos casos diagnosticados anualmente. Apesar de ser a primeira linha de tratamento, na maior parte das situações no momento do diagnóstico, a quimioterapia é considerada, muitas vezes, insuficiente. Neste sentido, a imunoterapia baseada em anticorpos tem-se apresentado como uma te...
In vitro studies into establishing therapeutic bioequivalence of complex topica...
Miranda, Margarida; Volmer, Zoe; Cornick, Alicia; Goody, Aidan; Cardoso, Catarina; Pais, Alberto A.C.C.; Brown, Marc; Vitorino, CarlaOver the past decade, topically applied drug products have experienced extraordinary price increases, due to the shortage of multisource generic drug products. This occurrence is mainly related to the underlying challenges evolved in topical bioequivalence documentation. Although there has been continuing regulatory efforts to present surrogate in vitro methods to clinical endpoint studies, there is still a con...
Rheology of Complex Topical Formulations: An Analytical Quality by Design Appro...
Chiarentin, Lucas; Cardoso, Catarina; Miranda, Margarida; Vitorino, CarlaAnalytical method validation ensures that a method provides trustworthy information about a particular sample when applied in accordance with the predefined protocol. According to regulatory standards, the rheological characteristics of topically applied semisolid formulations are one of the key elements involved in microstructure equivalence documentation. Therefore, for generic drug product manufacturers, it ...
Parenteral Ready-to-Use Fixed-Dose Combinations Including NSAIDs with Paracetam...
Silva, Fernando; Costa, Gustavo; Veiga, Francisco; Cardoso, Catarina; Paiva-Santos, Ana CláudiaThe combination of non-steroidal anti-inflammatory drugs (NSAIDs) with non-opioid analgesics is common in clinical practice for the treatment of acute painful conditions like post-operative and post-traumatic pain. Despite the satisfactory results achieved by oral analgesics, parenteral analgesia remains a key tool in the treatment of painful conditions when the enteral routes of administration are inconvenient...
Cosmopolitan tourists in P2P accommodation: an exploratory study of online revi...
Casais, Beatriz Graça Luz; Cardoso, CatarinaThis study compares guest reviews of Airbnb accommodations by country of origin, in order to identify cultural evidences. An exploratory study was conducted in two selected Airbnb accommodations through content analysis of 775 reviews by guests from 32 different countries. The authors analysed the data according to two dimensions of Hofstede’s Cultural Theory: (1) individualism/collectivism - the vision that th...
Impacto da COVID-19 na incidência de hospitalizações por lesões autoinfligidas ...
Cardoso, Catarina; Silva, Susana; Alves, Tatiana; Nunes, Baltazar; Afreixo, VeraCom o início da pandemia de COVID-19, a realidade até então conhecida mudou para muitas pessoas. A falta de convivência com familiares e amigos, insegurança, ansiedade, medo de contrair a infeção, problemas económicos decorrentes da pandemia e luto pelos familiares e amigos que perderam e dos quais não se puderam despedir devido às restrições, podem aumentar os riscos para a saúde mental e consequentemente para...
Drilling down the bioequivalence assessment of topical antifungal products : mi...
Miranda, Margarida; Cardoso, Catarina; Pais, Alberto A.C.C.; Brown, Marc; Vitorino, CarlaIn recent years, the regulatory mechanisms for topical generic product bioequivalence (BE) assessment have been subjected to noteworthy changes, with the FDA issuing product specific guidances, and the EMA adopting a more universal approach with the quality and equivalence of topical products draft guideline. The agencies advise on a modular strategy for BE documentation. Nevertheless, their scope, data analysi...
Rheology of complex topical formulations : an analytical quality by design appr...
Chiarentin, Lucas; Cardoso, Catarina; Miranda, Margarida; Vitorina, CarlaAnalytical method validation ensures that a method provides trustworthy information about a particular sample when applied in accordance with the predefined protocol. According to regulatory standards, the rheological characteristics of topically applied semisolid formulations are one of the key elements involved in microstructure equivalence documentation. Therefore, for generic drug product manufacturers, it ...