arrow
Back
V

Vinod P. Shah

pharmaceutical consultant

68H-index
441Paper Count
2.6WCitation Count
Published Papers 112
Publication Date
Biowaiver monograph for immediate-release solid oral dosage forms: Amlodipine Besylate
err2025-11-25
err0
PREAI
errPorfirio de la Cruz Cruz; Mauricio A. García; José Trinidad Pérez Urizar; Bertil Abrahamsson; Rodrigo Cristofoletti; Atsushi Kambayashi; Mehul Mehta; Alan Parr; James E. Polli; Vinod P Shah; Naseem Charoo; Sirajunisa Talath; Jennifer Dressman; Peter Langguth
errShare
errSave
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Empagliflozin
err2025-10-09
err0
PREAI
errReiji Negoya; Mayuki Tsueoka; Xichen Sun; Shuto Nishida; Bertil Abrahamsson; Naseem A. Charoo; Rodrigo Cristofoletti; Peter Langguth; Mehul Mehta; Alan Parr; James E. Polli; Vinod P. Shah; Jennifer Dressman; Atsushi Kambayashi
errShare
errSave
Biowaiver monographs for immediate-release solid oral dosage forms: Lemborexant
err2025-02-01
err1
PREAI
errBeran, Kristian; Abrahamsson, Bertil; Charoo, Naseem; Cristofoletti, Rodrigo; Holm, Rene; Kambayashi, Atsushi; Langguth, Peter; Mehta, Mehul; Parr, Alan; Polli, James E.; Shah, Vinod P.; Dressman, Jennifer
errShare
errSave
Biowaiver monographs for immediate-release solid oral dosage forms: Voriconazole
err2025-02-01
err0
PREAI
errBeran, Kristian; Abrahamsson, Bertil; Charoo, Naseem; Cristofoletti, Rodrigo; Holm, Rene; Kambayashi, Atsushi; Langguth, Peter; Parr, Alan; Polli, James E.; Shah, Vinod P.; Dressman, Jennifer
errShare
errSave
Biowaiver monograph for immediate-release solid oral dosage forms: Raltegravir potassium
err2024-11-01
err0
PREAI
errKambayashi, Atsushi; Iida, Masaki; Ishihara, Makoto; Takahashi, Yoshinori; Abrahamsson, Bertil; Charoo, Naseem A.; Cristofoletti, Rodrigo; Langguth, Peter; Mehta, Mehul; Parr, Alan; Polli, James E.; Shah, Vinod P.; Dressman, Jennifer
errShare
errSave
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fexofenadine
err2024-09-01
err0
PREAI
errCharoo, Naseem A.; Selvasudha, N.; Kath, Zahira Nala; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Kambayashi, Atsushi; Langguth, Peter; Mehta, Mehul; Parr, Alan; Polli, James E.; Shah, Vinod P.; Dressman, Jennifer
errShare
errSave
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Isavuconazonium Sulfate
err2024-02-01
err3
PREAI
errPlano, David; Rudolph, Niklas; Saal, Christoph; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Kambayashi, Atsushi; Langguth, Peter; Mehta, Mehul; Parr, Alan; Polli, James E.; Shah, Vinod P.; Charoo, Naseem; Dressman, Jennifer
errShare
errSave
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride
err2023-04-01
err9
PREAI
errCharoo, Naseem A.; Abdallah, Daud B.; Ahmed, Daoud T.; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Langguth, Peter; Mehta, Mehul; Parr, Alan; Polli, James E.; Shah, Vinod P.; Kambayashi, Atsushi; Dressman, Jennifer
errShare
errSave
Biowaiver Monograph for Immediate-Release Dosage Forms: Levamisole Hydrochloride
err2023-03-01
err3
PREAI
errKambayashi, Atsushi; de Meijer, Mariska; Wegman, Kim; van Veldhuizen, Cees; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Langguth, Peter; Mehta, Mehul; Parr, Alan; Polli, James E.; Shah, Vinod P.; Dressman, Jennifer
errShare
errSave
In vitro release test (IVRT): Principles and applications
err2022-10-01
err24
PREAI
errShah, Vinod P.; Miron, Dalia Simona; Radulescu, Flavian Stefan; Cardot, Jean -Michel; Maibach, Howard I.
errShare
errSave
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate
err2022-01-01
err8
errOAAI
errCharoo, Naseem A.; Abdallah, Daud B.; Bakheit, Ahmed Abdalla; Ul Haque, Kashif; Hassan, Hassan Ali; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Langguth, Peter; Mehta, Mehul; Parr, Alan; Polli, James E.; Shah, Vinod P.; Tajiri, Tomokazu; Dressman, Jennifer
errShare
errSave
A pragmatic regulatory approach for complex generics through the US FDA 505(j) or 505(b)(2) approval pathways
err2021-07-22
err11
errOAAI
errKlein, Kevin; Borchard, Gerrit; Shah, Vinod P.; Fluhmann, Beat; McNeil, Scott E.; de Vlieger, Jon S. B.
errShare
errSave
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine
err2021-05-01
err15
PREAI
errGarcia, Mauricio A.; Cristofoletti, Rodrigo; Abrahamsson, Bertil; Groot, Dirk W.; Parr, Alan; Polli, James E.; Mehta, Mehul; Shah, Vinod P.; Tomakazu, Tajiri; Dressman, Jennifer B.; Langguth, Peter
errShare
errSave
EBiowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metformin Hydrochloride
err2021-04-01
err16
PREAI
errMetry, Melissa; Shu, Yan; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Dressman, Jennifer B.; Groot, D. W.; Parr, Alan; Langguth, Peter; Shah, Vinod P.; Tajiri, Tomokazu; Mehta, Mehul U.; Polli, James E.
errShare
errSave
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride
err2020-09-01
err12
PREAI
errCharoo, Naseem A.; Abdallah, Daud B.; Parveen, Thahera; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Groot, Dirk W.; Langguth, Peter; Parr, Alan; Polli, James E.; Mehta, Mehul; Shah, Vinod P.; Tajiri, Tomokazu; Dressman, Jennifer
errShare
errSave
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate
err2020-06-01
err11
errOAAI
errPloeger, Gerlinde F.; Quizon, Paul M.; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Groot, Dirk W.; Parr, Alan; Langguth, Peter; Polli, James E.; Shah, Vinod P.; Tajiri, Tomokazu; Mehta, Mehul U.; Dressman, Jennifer
errShare
errSave
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron
err2019-10-01
err7
PREAI
errRajawat, Gopal Singh; Belubbi, Tejashree; Nagarsenker, Mangal S.; Abrahamsson, Bertil; Cristofoletti, Rodrigo; Groot, Dirk W.; Langguth, Peter; Parr, Alan; Polli, James E.; Mehta, Mehul; Shah, Vinod P.; Tajiri, Tomokazu; Dressman, Jennifer
errShare
errSave
Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: Drug Products, Including Biological Products, that Contain Nanomaterials
err2019-04-17
err18
errOAAI
errde Vlieger, Jon S. B.; Crommelin, Daan J. A.; Tyner, Katherine; Drummond, Daryl C.; Jiang, Wenlei; McNeil, Scott E.; Neervannan, Sesha; Crist, Rachael M.; Shah, Vinod P.
errShare
errSave
Report on the AAPS Immunogenicity Guidance Forum
err2019-04-16
err14
PREAI
errMyler, Heather; Gorovits, Boris; Phillips, Kelli; Devanarayan, Viswanath; Clements-Egan, Adrienne; Gunn, George R.; Kirshner, Susan; DeSilva, Binodh; Shah, Vinod P.
errShare
errSave
FIP Guidelines for Dissolution Testing of Solid Oral Products
err2018-12-01
err23
PREAI
errFriedel, Horst Dieter; Brown, Cynthia K.; Barker, Amy R.; Buhse, Lucinda F.; Keitel, Susanne; Kraemer, Johannes; Morris, John Michael; Reppas, Christos; Sperry, David C.; Sakai-Kato, Kumiko; Stickelmeyer, Mary P.; Shah, Vinod P.
errShare
errSave