Zobrazeno 1 - 7
of 7
pro vyhledávání: '"Larisa Wu"'
Autor:
Lawrence X. Yu, Andre Raw, Larisa Wu, Christina Capacci-Daniel, Ying Zhang, Susan Rosencrance
Publikováno v:
International Journal of Pharmaceutics: X, Vol 1, Iss , Pp - (2019)
This paper describes a new FDA’s pharmaceutical quality assessment system: Knowledge-aided Assessment & Structured Application (KASA). The KASA system is designed to: 1) capture and manage knowledge during the lifecycle of a drug product; 2) establ
Externí odkaz:
https://doaj.org/article/6a6151f19a454240a46df991fccfdfb7
Publikováno v:
AAPS PharmSciTech. 23(7)
Generic drugs play an important role in public health. However, the first review cycle approval rate for Abbreviated New Drug Applications (ANDAs) is generally low. To identify if the drug product (DP) manufacturing related deficiencies are the poten
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9e4993d32d5c3515ce5c54bd355a6096
https://pubmed.ncbi.nlm.nih.gov/36168006
https://pubmed.ncbi.nlm.nih.gov/36168006
Publikováno v:
International journal of pharmaceutics. 625
In this paper, we have studied Wurster Coating operation for the manufacture of modified release (MR) capsule products submitted to FDA as New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) by using a data-driven approach. We
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8fcb2424802ef0c25e038c0987334c0d
https://pubmed.ncbi.nlm.nih.gov/35902053
https://pubmed.ncbi.nlm.nih.gov/35902053
Publikováno v:
The Science and Regulations of Naturally Derived Complex Drugs ISBN: 9783030117504
A fundamental premise for generic approval is that the generic drug product contains the “same” active pharmaceutical ingredient as the brand name product. The vast majority of generics are traditional “small-molecule” drugs that have a simpl
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6cda0432763d7ee524ef9afa156d22bf
https://doi.org/10.1007/978-3-030-11751-1_9
https://doi.org/10.1007/978-3-030-11751-1_9
Autor:
Larisa Wu
The increasing interest of the pharmaceutical industry in peptide therapeutics has been a catalyst for the development of regulations in this area. Nevertheless, manufacturers and regulators continue to encounter scientific and regulatory challenges
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b12b7d43fce479506c0bf50c7d6638c7
https://doi.org/10.1039/9781788016445-00001
https://doi.org/10.1039/9781788016445-00001
Autor:
Andre Raw, Lawrence X. Yu, Susan Rosencrance, Larisa Wu, Christina Capacci-Daniel, Ying Zhang
Publikováno v:
International Journal of Pharmaceutics: X
International Journal of Pharmaceutics: X, Vol 1, Iss, Pp-(2019)
International Journal of Pharmaceutics: X, Vol 1, Iss, Pp-(2019)
Graphical abstract
This paper describes a new FDA’s pharmaceutical quality assessment system: Knowledge-aided Assessment & Structured Application (KASA). The KASA system is designed to: 1) capture and manage knowledge during the lifecycle of a
This paper describes a new FDA’s pharmaceutical quality assessment system: Knowledge-aided Assessment & Structured Application (KASA). The KASA system is designed to: 1) capture and manage knowledge during the lifecycle of a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4adacf3fd16020ef2d72a18b724be71f
https://doi.org/10.1016/j.ijpx.2019.100010
https://doi.org/10.1016/j.ijpx.2019.100010
Autor:
Mary Oates, Sau L. Lee, Tony Tong, Ganapathy Mohan, Giuseppe Randazzo, Michael P. Thien, Geoffrey K. Wu, Adam C. Fisher, Robert Ju, Richard T Lostritto, Emanuela Lacana, Bruce D. Johnson, Katherine M. Tyner, Stephen W. Hoag, Brian Hasselbalch, Grace McNally, Susan Rosencrance, Anna Schwendeman, Louis Yu, Moheb Nasr, Martin VanTrieste, Tara Gooen Bizjak, Henry A. Havel, Paul Seo, Siva Vaithiyalingam, Barbara Allen, Lawrence X. Yu, Ilgaz Akseli, Thomas F. O’Connor, Gregory E. Amidon, Ramesh Sood, Roger Nosal, Margaret Caulk, Ashley Boam, Janet Woodcock, Paula R Katz, Fionnuala Walsh, Robert Iser, Vinod P. Shah, Scott Furness, Larisa Wu, Russell Wesdyk, G. K. Raju, Joseph Famulare, Mahesh Ramanadham, Arzu Selen, Mehul Mehta, James E. Polli, David Doleski, Diane Zezza, Bernhardt L. Trout
Publikováno v:
The AAPS journal. 18(2)
The October 2015 FDA/PQRI Conference on Advancing Product Quality provided a forum for the exchange of ideas focused on drug product quality between regulatory agencies, the pharmaceutical industry, and academia. Key topics of the 2015 conference wer
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a4fa8e10c71dffd445e850573ee75ded
https://pubmed.ncbi.nlm.nih.gov/26860627
https://pubmed.ncbi.nlm.nih.gov/26860627