Search Results - "Faria, Ellen"

Analysis of the variability of the pharmacokinetics of multiple drugs in young adult and elderly subjects and its implications for acceptable daily exposures and cleaning validation limits by Streeter, Anthony J., Faria, Ellen C.

“…The elderly constitute a significant, potentially sensitive, subpopulation within the general population, which must be taken into account when performing risk…”
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Using default methodologies to derive an acceptable daily exposure (ADE) by Faria, Ellen C., Bercu, Joel P., Dolan, David G., Morinello, Eric J., Pecquet, Alison M., Seaman, Christopher, Sehner, Claudia, Weideman, Patricia A.

“…This manuscript discusses the different historical and more recent default approaches that have been used to derive an acceptable daily exposure (ADE). While…”
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Guidance on the establishment of acceptable daily exposure limits (ADE) to support Risk-Based Manufacture of Pharmaceutical Products by Sargent, Edward V., Faria, Ellen, Pfister, Thomas, Sussman, Robert G.

“…► ADEs used to establish cleaning validation limits for pharmaceutical products. ► ADEs are defined as acceptable daily exposures for patients. ► ADEs defined…”
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Issues and approaches for ensuring effective communication on acceptable daily exposure (ADE) values applied to pharmaceutical cleaning by Olson, Michael J., Faria, Ellen C., Hayes, Eileen P., Jolly, Robert A., Barle, Ester Lovsin, Molnar, Lance R., Naumann, Bruce D., Pecquet, Alison M., Shipp, Bryan K., Sussman, Robert G., Weideman, Patricia A.

“…This manuscript centers on communication with key stakeholders of the concepts and program goals involved in the application of health-based pharmaceutical…”
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A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing – Operational considerations by Hayes, Eileen P., Jolly, Robert A., Faria, Ellen C., Barle, Ester Lovsin, Bercu, Joel P., Molnar, Lance R., Naumann, Bruce D., Olson, Michael J., Pecquet, Alison M., Sandhu, Reena, Shipp, Bryan K., Sussman, Robert G., Weideman, Patricia A.

“…A European Union (EU) regulatory guideline came into effect for all new pharmaceutical products on June 1st, 2015, and for all existing pharmaceutical products…”
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Avaliação Psicológica no Brasil: Caminhos e Possibilidades: Resenha do Livro Avaliação Psicológica: A Atualidade da Prática Profissional by Faria, Ellen Carolina de Paula, Santos de Farias, Eliana, Gomes de Azevedo, Amanda Miranda

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Treinamento de força e resistência muscular para pacientes com fibromialgia: uma revisão integrativa da literatura by Carvalho, Natane Moreira, Pernambuco, Andrei Pereira, Soares, Betânia Maria, Vilela, Daniela Luzia, Faria, Ellen Cristina, Lacerda, Istefani Gonçalves de, Sales, Izabela Diniz

“…Introdução: A síndrome da fibromialgia (FM) é caracterizada por dor crônica e generalizada, fadiga, depressão, cefaleia e distúrbios do sono, além de uma série…”
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A Human Health Risk Assessment of Pharmaceuticals in the Aquatic Environment by Schulman, L J, Sargent, E V, Naumann, B D, Faria, E C, Dolan, D G, Wargo, J P

“…Analyses were conducted on four pharmaceutical compounds, representing different therapeutic classes, to evaluate the presence and potential adverse human…”
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A Human Health Risk Assessment of Pharmaceuticals in the Aquatic Environment by Schulman, Lisa J., Sargent, Edward V., Naumann, Bruce D., Faria, Ellen C., Dolan, David G., Wargo, John P.

“…Analyses were conducted on four pharmaceutical compounds, representing different therapeutic classes, to evaluate the presence and potential adverse human…”
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Case Studies of Categorical Data-Derived Adjustment Factors by Naumann, Bruce D., Silverman, Keith C., Dixit, Rakesh, Faria, Ellen C., Sargent, Edward V.

“…Investigations were performed on representative compounds from five different therapeutic classes to evaluate the use of categorical data-derived adjustment…”
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The Importance of Human Data in the Establishment of Occupational Exposure Limits by Sargent, Edward V., Naumann, Bruce D., Dolan, David G., Faria, Ellen C., Schulman, Lisa

“…The use of animal vs. human data for the purposes of establishing human risk was examined for four pharmaceutical compounds: acetylsalicylic acid,…”
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The Importance of Human Data in the Establishment of Occupational Exposure Limits by Sargent, Edward V., Naumann, Bruce D., Dolan, David G., Faria, Ellen C., Schulman, Lisa

“…The use of animal vs. human data for the purposes of establishing human risk was examined for four pharmaceutical compounds: acetylsalicylic acid,…”
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Establishing Data-Derived Adjustment Factors from Published Pharmaceutical Clinical Trial Data by Silverman, Keith C., Naumann, Bruce D., Holder, Daniel J., Dixit, Rakesh, Faria, Ellen C., Sargent, Edward V., Gallo, Michael A.

“…In non-cancer risk assessment the goal traditionally has been to protect the majority of people by setting limits that account for interindividual variability…”
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In Vivo Effects of Chromium by Witmer, Charlotte, Faria, Ellen, Park, Hyoung-Sook, Sadrieh, Nakissa, Yurkow, Edward, O'Connell, Sean, Sirak, Andrea, Schleyer, Heinz

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In Vivo Effects of Chromium by Witmer, Charlotte, Faria, Ellen, Park, Hyoung-Sook, Sadrieh, Nakissa, Yurkow, Edward, O'Connell, Sean, Sirak, Andrea, Schleyer, Heinz

“…The production of reactive oxygen species on addition of hexavalent chromium (potassium dichromate, K2Cr2O7) to lung cells in culture was studied using flow…”
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Distribution of chromate and the effects on hepatic and pulmonary mixed function oxidase systems by Faria, Ellen Contente

“…It was the hypothesis of this research that the lung sequesters Cr regardless of the route of Cr(VI) administration, thus partially explaining the…”
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Avaliação Psicológica no Brasil: Caminhos e Possibilidades by Faria, Ellen Carolina de Paula, Azevedo, Amanda Miranda Gomes de, Farias, Eliana Santos de

“…Para tanto, serão utilizadas as seguintes siglas: "TF", para testes favoráveis; "TD" para testes desfavoráveis; "NP" para instrumentos não privativos; "NA"…”
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