Development and validation of an HPLC–MS/MS method to quantify clopidogrel acyl glucuronide, clopidogrel acid metabolite, and clopidogrel in plasma samples avoiding analyte back-co... by Silvestro, Luigi, Gheorghe, Mihaela, Iordachescu, Adriana, Ciuca, Valentin, Tudoroniu, Ariana, Rizea Savu, Simona, Tarcomnicu, Isabela

Get full text

Development and validation of an HPLC–MS/MS method to determine clopidogrel in human plasma. Use of incurred samples to test back-conversion by Silvestro, Luigi, Gheorghe, Mihaela Cristina, Tarcomnicu, Isabela, Savu, Silviu, Savu, Simona Rizea, Iordachescu, Adriana, Dulea, Constanta

Get full text

Pharmacokinetics and Bioequivalence of a Generic Ticagrelor 90-mg Formulation Versus the Innovator Product in Healthy White Subjects Under Fasting Conditions by Rizea-Savu, Simona, Duna, Simona Nicoleta, Ghita, Adrian, Iordachescu, Adriana, Garlea, Ioana, Chirila, Marinela

Get full text

The Effect of Food on the Single‐Dose Bioavailability and Tolerability of the Highest Marketed Strength of Duloxetine by Rizea‐Savu, Simona, Duna, Simona Nicoleta, Ghita, Adrian, Iordachescu, Adriana, Chirila, Marinela

Get full text

GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline by Nehls, Corey, Buonarati, Michael, Cape, Stephanie, Islam, Rafiq, Satterwhite, Christina, Briscoe, Chad, Hayes, Roger, Dinan, Andrew, Sales, Kurt, Anderson, Shelby, Vance, Jennifer, Lindsay, John, Zimmer, Jennifer, Couerbe, Philippe, Khadang, Ardeshir, Maasjo, Sarah, Bravo, Orlando, Lindley, Kathie, Moran, Liam, Sangster, Timothy, Vija, Jenifer, Stamatopoulos, John, Lin, Jenny, Reuschel, Scott, Underberg, Angie, MacNeill, Robert, Matassa, Luca, Spytko, Adriane, Garofolo, Wei, Savoie, Natasha, Rhyne, Paul, Ambrosius, Jason, Barra, Valentine, Dufield, Dawn, Luna, Marsha, Spriggs, Franklin, Fedorov, Evgueni, Ritzén, Hanna, Fatmi, Saadya, Kane, Cheikh, Bouhajib, Mohammed, DiMarco, Chantal, Iordachescu, Adriana, Tudoroniu, Ariana, Farley, Esme, Stouffer, Bruce, Tabler, Edward, McCown, Stacie, Bower, Joseph, Harrison, Travis, Karnik, Shane, Brown, Michael, Joyce, Philip, DuBey, Ira, Hoffpauir, Brian, Boudreau, Nadine, Bergeron, Jerome, Wang, Hao, Feng, Hao, Zhou, Shaolian, Wells, Edward, Pirro, John, Fang, Xinping, Shi, Jing, Yang, Changming

Get full text

LC–MS–MS Method for the Simultaneous Determination of Donepezil Enantiomers in Plasma by Iordachescu, Adriana, Silvestro, Luigi, Tudoroniu, Ariana, Rizea Savu, Simona, Ciuca, Valentin

Get full text

11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose valid... by Islam, Rafiq, Briscoe, Chad, Bower, Joseph, Cape, Stephanie, Arnold, Mark, Hayes, Roger, Warren, Mark, Karnik, Shane, Stouffer, Bruce, Xiao, Yi Qun, van der Strate, Barry, Sikkema, Daniel, Fang, Xinping, Tudoroniu, Ariana, Tayyem, Rabab, Brant, Ashley, Spriggs, Franklin, Barry, Colin, Khan, Masood, Keyhani, Anahita, Zimmer, Jennifer, Caturla, Maria Cruz, Couerbe, Philippe, Khadang, Ardeshir, Bourdage, James, Datin, Jim, Zemo, Jennifer, Hughes, Nicola, Fatmi, Saadya, Sheldon, Curtis, Fountain, Scott, Satterwhite, Christina, Colletti, Kelly, Vija, Jenifer, Yu, Mathilde, Stamatopoulos, John, Lin, Jenny, Wilfahrt, Jim, Dinan, Andrew, Ohorodnik, Susan, Hulse, James, Patel, Vimal, Garofolo, Wei, Savoie, Natasha, Brown, Michael, Papac, Damon, Buonarati, Mike, Hristopoulos, George, Beaver, Chris, Boudreau, Nadine, Williard, Clark, Liu, Yansheng, Ray, Gene, Warrino, Dominic, Xu, Allan, Green, Rachel, Hayward-Sewell, Joanne, Marcelletti, John, Sanchez, Christina, Kennedy, Michael, Charles, Jessica St, Bouhajib, Mohammed, Nehls, Corey, Tabler, Edward, Tu, Jing, Joyce, Philip, Iordachescu, Adriana, DuBey, Ira, Lindsay, John, Yamashita, Jim, Wells, Edward

Get full text

The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and co... by Cape, Stephanie, Islam, Rafiq, Nehls, Corey, Allinson, John, Safavi, Afshin, Bennett, Patrick, Hulse, James, Beaver, Chris, Khan, Masood, Karnik, Shane, Caturla, Maria Cruz, Lowes, Steve, Iordachescu, Adriana, Silvestro, Luigi, Tayyem, Rabab, Shoup, Ron, Mowery, Stephanie, Keyhani, Anahita, Wakefield, Andrea, Li, Yinghe, Zimmer, Jennifer, Torres, Javier, Couerbe, Philippe, Khadang, Ardeshir, Bourdage, James, Hughes, Nicola, Awaiye, Kayode, Matthews, Brent, Fatmi, Saadya, Johnson, Rhonda, Satterwhite, Christina, Yu, Mathilde, Lin, Jenny, Cojocaru, Laura, Fiscella, Michele, Thomas, Eric, Kurylak, Kai, Kamerud, John, Lin, Zhongping (John), Garofolo, Wei, Savoie, Natasha, Buonarati, Mike, Boudreau, Nadine, Williard, Clark, Liu, Yansheng, Warrino, Dominic, Kale, Prashant, Adcock, Neil, Shekar, Radha, O'Connor, Edward, Ritzen, Hanna, Sanchez, Christina, Hayes, Roger, Bouhajib, Mohammed, Savu, Simona Rizea, Stouffer, Bruce, Tabler, Edward, Tu, Jing, Briscoe, Chad, der Strate, Barry van, Rhyne, Paul, Conliffe, Phyllis, DuBey, Ira, Yamashita, Jim, Tang, Daniel, Groeber, Elizabeth, Vija, Jenifer, Malone, Michele, Osman, Mohamed

Get full text