Zobrazeno 1 - 9
of 9
pro vyhledávání: '"Haritha, Mandula"'
Autor:
Nikolay Zaborenko, Tessa M. Carducci, Alexander Ryckaert, Haritha Mandula, Matthew J. Walworth, Casey J. Smith, Sandra Suarez-Sharp, Melanie Dumarey, Sara Manteiga, Sarah Nielsen, Stan Altan, Adriene Malsbury, Beverly Nickerson, Yanmei Lan
Publikováno v:
Dissolution Technologies. 29:150-172
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8b647dc48857f621b49515bc6919c0e9
https://doi.org/10.14227/dt290322p150
https://doi.org/10.14227/dt290322p150
Autor:
Evangelos Kotzagiorgis, Shinichi Kijima, Om Anand, Yang Zhao, Sandra Suarez-Sharp, Talia Flanagan, Min Li, Baoming Ning, Poonam Delvadia, Shefali Kakar, Amitava Mitra, Greg Rullo, Jennifer B. Dressman, Neil Parrott, Erik Sjögren, Banu S. Zolnik, Shereeni Veerasingham, Paul A. Dickinson, Gustavo Mendes Lima Santos, Tycho Heimbach, Haritha Mandula, Christophe Tistaert, Fang Wu, Kimberly Raines, Satish Sharan, Xavier Pepin, Andrew Babiskin
Publikováno v:
Journal of Pharmaceutical Sciences. 110:594-609
This report summarizes the proceedings for Day 3 of the workshop titled "Current State and Future Expectations of Translational Modeling Strategies toSupportDrug Product Development, Manufacturing Changes and Controls". From a drug product quality pe
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fd0af49b3fa2be786e937037a5062f10
https://doi.org/10.1016/j.xphs.2020.10.059
https://doi.org/10.1016/j.xphs.2020.10.059
Autor:
Andreas M, Abend, Limin, Zhang, Emilija, Fredro-Kumbaradzi, Thomas, Hoffelder, Michael J, Cohen, Om, Anand, Poonam, Delvadia, Haritha, Mandula, Zhen, Zhang, Evangelos, Kotzagiorgis, Susan, Lum, Victor Gomes, Pereira, Amy, Barker, David, Lavrich, Johannes, Kraemer, Sandra, Sharp-Suarez
Publikováno v:
The AAPS Journal. 24
This report summarizes podium presentations and breakout sessions from the second day of the 2019 M-CERSI workshop on In Vitro Dissolution Similarity Assessment in Support of Drug Product Quality: What, How, and When? Presenters from the U.S. Food an
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9037391d8f0d4c162e0e0e2393bc7978
https://doi.org/10.1208/s12248-022-00691-4
https://doi.org/10.1208/s12248-022-00691-4
Autor:
Shinichi Kijima, Filippos Kesisoglou, Kimberly Raines, Andreas Abend, Xinyuan Zhang, Paul Seo, Poonam Delvadia, Nagesh Bandi, Min Li, Evangelos Kotzagiorgis, Sandra Suarez-Sharp, Erik Sjögren, Tycho Heimbach, Anna Nordmark, Andrew Babiskin, Patrick J. Marroum, Michael J. Cohen, Haritha Mandula
Publikováno v:
The AAPS journal. 20(6)
This publication summarizes the proceedings of day 3 of a 3-day workshop on "Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development." Specifically, this publication discusses the current approaches in building
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b084be6477a3b7ae921931825751e1da
https://pubmed.ncbi.nlm.nih.gov/30151612
https://pubmed.ncbi.nlm.nih.gov/30151612
Autor:
Ramana S. Uppoor, Ethan Stier, Dakshina Murthy Chilukuri, Pariban Dhanormchitphong, Mehul Mehta, Tapash Ghosh, Lawrence X. Yu, Haritha Mandula, Paul Seo, Kimberly Raines, Janet Woodcock, Angelica Dorantes, Donna A. Volpe, Dale P. Conner, Jayabharathi Vaidyanathan
Publikováno v:
Molecular pharmaceutics. 14(12)
The FDA guidance on application of the biopharmaceutics classification system (BCS) for waiver of in vivo bioequivalence (BE) studies was issued in August 2000. Since then, this guidance has created worldwide interest among biopharmaceutical scientis
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2a84fc4a02938026c93ad8993a5e0211
https://pubmed.ncbi.nlm.nih.gov/29076742
https://pubmed.ncbi.nlm.nih.gov/29076742
Publikováno v:
Journal of Pharmacology and Experimental Therapeutics. 317:667-675
Many studies have reported greater drug uptake into brain than that predicted based upon existing models using the free fraction (f(u)) of drug in arterial serum. To explain this difference, circulating plasma proteins have been suggested to interact
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e495e9892921a23d895b3a2eb6e1de09
https://doi.org/10.1124/jpet.105.097402
https://doi.org/10.1124/jpet.105.097402
Establishing bioequivalence (BE) of drugs indicated to treat cancer poses special challenges. For ethical reasons, often, the studies need to be conducted in cancer patients rather than in healthy volunteers, especially when the drug is cytotoxic. Th
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::449f2e7985024cec675051d54c5c1a4c
https://europepmc.org/articles/PMC4309807/
https://europepmc.org/articles/PMC4309807/
Publikováno v:
Handbook of Biologically Active Peptides ISBN: 9780123694423
Amino acids serve multiple roles in brain as neurotransmitters, neurotransmitter precursors, and building blocks of peptides and proteins. Their levels in brain are closely regulated in part by controlled trans port across the blood–brain barrier (
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::09b343b75d1aac661a2b8407bb2bed4b
https://doi.org/10.1016/b978-012369442-3/50200-2
https://doi.org/10.1016/b978-012369442-3/50200-2
Publikováno v:
Pharmaceutical research. 23(5)
To determine the roles of blood–brain barrier (BBB) transport and plasma protein binding in brain uptake of nonsteroidal anti-inflammatory drugs (NSAIDs)—ibuprofen, flurbiprofen, and indomethacin. Brain uptake was measured using in situ rat brain
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c9ebd3863ed80fa91945bf76d70053b1
https://pubmed.ncbi.nlm.nih.gov/16715377
https://pubmed.ncbi.nlm.nih.gov/16715377