Development and validation of a headspace GC-MS method to evaluate the interconversion of impurities and the product quality of liquid hand sanitizers

Autor: Nicolas Abrigo, Connie Ruzicka, Patrick Faustino, Neil Stiber, Agnes NguyenPho, Thomas O’Connor, Diaa Shakleya

Publikováno v: AAPS Open, Vol 8, Iss 1, Pp 1-13 (2022)

Abstract The COVID-19 pandemic has led to increased usage of hand sanitizer products by the public to prevent the spread of COVID-19 and decrease the likelihood of acquiring the disease. The increase in demand has also led to an increase in the numbe

Externí odkaz: https://doaj.org/article/eafcceb602fb4e0886492c712ef3a0b2

2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

Autor: Andrew P Mayer, Jinhui Zhang, Sam Haidar, Sandra Nuti, Shyam Sarikonda, Therese Solstad, Megan McCausland, Fabian Junker, Elana Cherry, Susan M. Spitz, Tahseen Mirza, Anna Edmison, Patrick Faustino, Yan Zhang, Rafiq Islam, Steven Eck, Christèle Gonneau, Fabio Garofolo, Nilufer Tampal, Kevin Maher, Lisa Patti-Diaz, Kun Peng, Alberto Robert, Yow-Ming Wang, Rachel Palmer, Marcela Araya, Lakshmi Amaravadi, Alison Joyce, Daniela Verthelyi, Giane Sumner, Andrew Exley, Sally Fischer, Gustavo Mendes Lima Santos, Michael McGuinness, Yoshiro Saito, Alessandra Vitaliti, Naveen Dakappagari, Daniel Baltrukonis, Christina Satterwhite, Gregory Hopkins, Gregor Jordan, Akiko Ishii-Watabe, Arindam Dasgupta, David Lanham, Priscila Camillo Teixeira, Mitra Azadeh, Stephen Vinter, Sumit Kar, Lucia Zhang, Linda Terry, Michael Nathan Hedrick, João Pedras-Vasconcelos, Shabnam Tangri, Florian Neff, Natasha Savoie, Weili Yan, Matthew Andisik, Mohsen Rajabi Abhari, Richard Siggers, Lindsay King, Diaa Shakleya, Isabelle Cludts, Nisha Palackal, Meiyu Shen, Ulrike Sommer, Sylvie Bertholet, Susan Kirshner, Cherie Green, Christine Grimaldi, Susan Stojdl, Kristina McGuire, Vilma Decman, Jose Estevam, Suman Dandamudi, Seema Kumar, Richard Wnek, Catherine Soo, Haoheng Yan, Jan Welink, Rebecca Elliott, Abbas Bandukwala

Publikováno v: Bioanalysis. 13:295-361

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract res

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::e5706237408b458c58ed63921b541745
https://doi.org/10.4155/bio-2021-0005

2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (

Autor: Susan, Spitz, Yan, Zhang, Sally, Fischer, Kristina, McGuire, Ulrike, Sommer, Lakshmi, Amaravadi, Abbas, Bandukwala, Steven, Eck, Fabio, Garofolo, Rafiqul, Islam, Gregor, Jordan, Lindsay, King, Yoshiro, Saito, Giane, Sumner, Linda, Terry, Alessandra, Vitaliti, Yow-Ming, Wang, Christine, Grimaldi, Alison, Joyce, Rachel, Palmer, Matthew, Andisik, Marcela, Araya, Mitra, Azadeh, Daniel, Baltrukonis, Rebecca, Elliott, Sam, Haidar, Seema, Kumar, Andrew, Mayer, Florian, Neff, Nisha, Palackal, Kun, Peng, Mohsen Rajabi, Abhari, Christina, Satterwhite, Natasha, Savoie, Catherine, Soo, Stephen, Vinter, Jan, Welink, Weili, Yan, Kevin, Maher, David, Lanham, Sylvie, Bertholet, Naveen, Dakappagari, Christèle, Gonneau, Cherie, Green, Fabian, Junker, Sumit, Kar, Lisa, Patti-Diaz, Shyam, Sarikonda, Megan, McCausland, Priscila Camillo, Teixeira, Vilma, Decman, Jose, Estevam, Michael, Hedrick, Alberto Hidalgo, Robert, Gregory, Hopkins, Sandra, Nuti, Shabnam, Tangri, Richard, Wnek, Suman, Dandamudi, Arindam, Dasgupta, Anna, Edmison, Patrick, Faustino, Michael, McGuinness, Gustavo Mendes, Lima Santos, Tahseen, Mirza, Diaa, Shakleya, Susan, Stojdl, Nilufer, Tampal, Jinhui, Zhang, Elana, Cherry, Isabelle, Cludts, Andrew, Exley, Akiko, Ishii-Watabe, Susan, Kirshner, Joao, Pedras-Vasconcelos, Meiyu, Shen, Richard, Siggers, Therese, Solstad, Daniela, Verthelyi, Haoheng, Yan, Lucia, Zhang

Publikováno v: Bioanalysis. 13(5)

The 14

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::33bd3a6787b755dd13ebad7010c28d32
https://pubmed.ncbi.nlm.nih.gov/33511867

Organic Impurities in Drug Substance: Origin, Control, and Measurement

Autor: George Lunn, Linda Ng, Patrick Faustino

Publikováno v: Analysis of Drug Impurities

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::21af817454f8a1aaa7da74fc14ac7c1b
https://doi.org/10.1002/9780470988749.ch1