Zobrazeno 1 - 10
of 310
pro vyhledávání: '"Babiskin A"'
Autor:
Ming‐Liang Tan, Zongming Gao, Andrew Babiskin, Myong‐Jin Kim, Lanyan Fang, Lei Zhang, Liang Zhao
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 2, Pp 247-256 (2024)
Abstract Proton pump inhibitors (PPIs) can affect the release of drugs from their dosage forms in vivo by elevating the gastric pH. Our recent clinical study has demonstrated that drug–drug interactions (DDIs) exist between a PPI, omeprazole, and n
Externí odkaz:
https://doaj.org/article/7ace8b2458c443dda103dac182085770
Autor:
Ming‐Liang Tan, Sajeev Chandran, Rebeka Jereb, Khondoker Alam, Robert Bies, Darby Kozak, Ross Walenga, Maxime Le Merdy, Andrew Babiskin
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 631-638 (2023)
Abstract For approval, a proposed generic drug product must demonstrate it is bioequivalent (BE) to the reference listed drug product. For locally acting drug products, conventional BE approaches may not be feasible because measurements in local tiss
Externí odkaz:
https://doaj.org/article/07ce5f1933ba47038ba1a9054cdc69a8
Autor:
Andrew Babiskin, Fang Wu, Youssef Mousa, Ming‐Liang Tan, Eleftheria Tsakalozou, Ross L. Walenga, Miyoung Yoon, Sam G. Raney, James E. Polli, Anna Schwendeman, Vishalakshi Krishnan, Lanyan Fang, Liang Zhao
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 619-623 (2023)
Abstract On September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bi
Externí odkaz:
https://doaj.org/article/44b240479fc442e095e071b1478a7197
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 552-555 (2023)
Externí odkaz:
https://doaj.org/article/818aecd9dc364a1bbd1d8a96989f7924
Autor:
Kimbell, J.S., Garcia, G.J.M., Schroeter, J.D., Sheth, P., Vallorz, E.L., III, Saluja, B., Babiskin, A.H., Tian, G., Walenga, R.L.
Publikováno v:
In Journal of Aerosol Science November 2023 174
Autor:
Newman, Bryan, Babiskin, Andrew, Bielski, Elizabeth, Boc, Susan, Dhapare, Sneha, Fang, Lanyan, Feibus, Katharine, Kaviratna, Anubhav, Li, Bing V., Luke, Markham C., Ma, Tian, Spagnola, Michael, Walenga, Ross L., Wang, Zhong, Zhao, Liang, El-Gendy, Nashwa, Bertha, Craig M., Abd El-Shafy, Mohammed, Gaglani, Dhaval K.
Publikováno v:
In Advanced Drug Delivery Reviews November 2022 190
Autor:
El-Gendy, Nashwa, Bertha, Craig M., Abd El-Shafy, Mohammed, Gaglani, Dhaval K., Babiskin, Andrew, Bielski, Elizabeth, Boc, Susan, Dhapare, Sneha, Fang, Lanyan, Feibus, Katharine, Kaviratna, Anubhav, Li, Bing V., Luke, Markham C., Ma, Tian, Newman, Bryan, Spagnola, Michael, Walenga, Ross L., Zhao, Liang
Publikováno v:
In Advanced Drug Delivery Reviews October 2022 189
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 5, Pp 399-411 (2021)
Abstract Establishing bioequivalence (BE) for dermatological drug products by conducting comparative clinical end point studies can be costly and the studies may not be sufficiently sensitive to detect certain formulation differences. Quantitative me
Externí odkaz:
https://doaj.org/article/45fc66144a2f487ebb03a28e80d1f1f0
Autor:
Yoon, Miyoung1 (AUTHOR), Babiskin, Andrew1 (AUTHOR), Hu, Meng1 (AUTHOR), Wu, Fang1 (AUTHOR), Raney, Sam G.2 (AUTHOR), Fang, Lanyan1 (AUTHOR), Zhao, Liang1 (AUTHOR) liang.zhao@fda.hhs.gov
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology. May2023, Vol. 12 Issue 5, p552-555. 4p.
Autor:
Babiskin, Andrew1 (AUTHOR) andrew.babiskin@fda.hhs.gov, Wu, Fang1 (AUTHOR) fang.wu@fda.hhs.gov, Mousa, Youssef1 (AUTHOR), Tan, Ming‐Liang1 (AUTHOR), Tsakalozou, Eleftheria1 (AUTHOR), Walenga, Ross L.1 (AUTHOR), Yoon, Miyoung1 (AUTHOR), Raney, Sam G.2 (AUTHOR), Polli, James E.3 (AUTHOR), Schwendeman, Anna4 (AUTHOR), Krishnan, Vishalakshi4 (AUTHOR), Fang, Lanyan1 (AUTHOR), Zhao, Liang1 (AUTHOR)
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology. May2023, Vol. 12 Issue 5, p619-623. 5p.