Zobrazeno 1 - 10
of 18
pro vyhledávání: '"Tomokazu, Tajiri"'
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate
Autor:
Rodrigo Cristofoletti, Mehul Mehta, Tomokazu Tajiri, Jennifer B. Dressman, Peter Langguth, James E. Polli, Naseem A. Charoo, Hassan A. Hassan, Daud Baraka Abdallah, Ahmed Abdalla Bakheit, Bertil Abrahamsson, Vinod P. Shah, Kashif Ul Haque, Alan F. Parr
Publikováno v:
Journal of Pharmaceutical Sciences. 111:2-13
Sitagliptin is an antihyperglycemic drug used in adults for the treatment of diabetes Type 2. Literature data and in-house experiments were applied in this monograph to assess whether methods based on the Biopharmaceutics Classification System (BCS)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eedf2809a39a6108b761038312e909ae
https://doi.org/10.1016/j.xphs.2021.09.031
https://doi.org/10.1016/j.xphs.2021.09.031
Autor:
Linda Gijzen, Kouichi Yoshinari, Niels Ouwerkerk, Kei Motonaga, Marleen Bokkers, Yuki Hagiwara, Remko van Vught, Harumi Kumagai, Tomokazu Tajiri, Rumaisha Annida, Yoshifumi Katakawa
Publikováno v:
Journal of Pharmaceutical Sciences. 111:214-224
The aim of this study was to develop an in vitro drug permeability methodology which mimics the gastrointestinal environment more accurately than conventional 2D methodologies through a three-dimensional (3D) Caco-2 tubules using a microphysiological
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::536eaebc2e2e2421c39c2c797264f2bf
https://doi.org/10.1016/j.xphs.2021.11.016
https://doi.org/10.1016/j.xphs.2021.11.016
Autor:
Harshvardhan Modh, Takatsune Yoshida, Ryo Kojima, Saeed Shanehsazzadeh, Mukul Ashtikar, Masanori Kaihara, Matthias G. Wacker, Ge Fiona Gao, Tomokazu Tajiri
Publikováno v:
Journal of Controlled Release. 329:372-384
Today, tacrolimus represents a cornerstone of immunosuppressive therapy for liver and kidney transplants and remains subject of preclinical and clinical investigations, aiming at the development of long-acting depot formulations for subcutaneous inje
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5072556ee62ff7eeb2a08394888dad6c
https://doi.org/10.1016/j.jconrel.2020.11.055
https://doi.org/10.1016/j.jconrel.2020.11.055
Autor:
Shin-ichiro Kimura, Masanori Kaihara, Yasunori Iwao, Yoshifumi Katakawa, Kei Motonaga, Kazuhiro Hojo, Hiromu Kondo, Takatsune Yoshida, Tomokazu Tajiri, Atsushi Kambayashi
Publikováno v:
Chemical and Pharmaceutical Bulletin. 67:467-475
The aim of this study was to establish a novel approach to in vitro dissolution evaluation using a combination of the paddle method and a dialysis membrane, both to predict the overall in vivo performance of tacrolimus microspheres and also to identi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::716df3c02f70a77a984fb69fe39b75e1
https://doi.org/10.1248/cpb.c18-01018
https://doi.org/10.1248/cpb.c18-01018
Autor:
Alan F. Parr, Yan Shu, James E. Polli, Vinod P. Shah, D.W. Groot, Bertil Abrahamsson, Peter Langguth, Rodrigo Cristofoletti, Melissa Metry, Mehul Mehta, Jennifer B. Dressman, Tomokazu Tajiri
Publikováno v:
Journal of pharmaceutical sciences. 110(4)
Data are examined regarding possible waiver of in vivo bioequivalence testing (i.e. biowaiver) for approval of metformin hydrochloride (metformin) immediate-release solid oral dosage forms. Data include metformin's Biopharmaceutics Classification Sys
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3617fdd4cee9ef5b72a8748079bd3604
https://pubmed.ncbi.nlm.nih.gov/33450218
https://pubmed.ncbi.nlm.nih.gov/33450218
Autor:
Rodrigo Cristofoletti, Daud Baraka Abdallah, Thahera Parveen, Jennifer B. Dressman, Mehul Mehta, Naseem A. Charoo, Bertil Abrahamsson, D.W. Groot, Vinod P. Shah, James E. Polli, Alan F. Parr, Peter Langguth, Tomokazu Tajiri
Publikováno v:
Journal of pharmaceutical sciences. 109(9)
In this monograph, literature data is reviewed to evaluate the feasibility of waiving in vivo bioequivalence testing and instead applying the Biopharmaceutics Classification System (BCS) based methods to the approval of immediate-release solid oral d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b9523f9600e8c361f2750ae47af155ec
https://pubmed.ncbi.nlm.nih.gov/32534881
https://pubmed.ncbi.nlm.nih.gov/32534881
Autor:
Jennifer B. Dressman, Rodrigo Cristofoletti, Bertil Abrahamsson, Mehul Mehta, D.W. Groot, Peter Langguth, Tomokazu Tajiri, James E. Polli, Gerlinde F. Plöger, Vinod P. Shah, Alan F. Parr
Publikováno v:
Journal of Pharmaceutical Sciences. 107:1761-1772
Literature data relevant to the decision to waive in vivo bioequivalence testing for the approval of generic immediate release solid oral dosage forms of proguanil hydrochloride are reviewed. To elucidate the Biopharmaceutics Classification System (B
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4c4e7723f89a31e44883b5758dce7656
https://doi.org/10.1016/j.xphs.2018.03.009
https://doi.org/10.1016/j.xphs.2018.03.009
Autor:
Bertil Abrahamsson, Paul M. Quizon, Gerlinde F. Plöger, Rodrigo Cristofoletti, Alan F. Parr, D.W. Groot, Tomokazu Tajiri, Vinod P. Shah, Jennifer B. Dressman, Mehul Mehta, James E. Polli, Peter Langguth
Publikováno v:
Journal of pharmaceutical sciences. 109(6)
Literature data and results of experimental studies relevant to the decision to allow waiver of bioequivalence studies in humans for the approval of immediate release solid oral dosage forms containing cephalexin monohydrate are presented. Solubility
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d9c17ce1362ae0356fefbb169d76c24e
https://pubmed.ncbi.nlm.nih.gov/32240696
https://pubmed.ncbi.nlm.nih.gov/32240696
Autor:
Alan F. Parr, Tomokazu Tajiri, Bertil Abrahamsson, Jennifer B. Dressman, Mangal S. Nagarsenker, Vinod P. Shah, Rodrigo Cristofoletti, James E. Polli, Peter Langguth, Mehul Mehta, Gopal Singh Rajawat, D.W. Groot, Tejashree Belubbi
Literature data pertaining to the physicochemical, pharmaceutical, and pharmacokinetic properties of ondansetron hydrochloride dihydrate are reviewed to arrive at a decision on whether a marketing authorization of an immediate release (IR) solid oral
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::13e1fe19bf6d811851b05e91928271b8
http://hdl.handle.net/10029/623205
http://hdl.handle.net/10029/623205
Autor:
Masanori, Kaihara, Kazuhiro, Hojo, Tomokazu, Tajiri, Atsushi, Kambayashi, Takatsune, Yoshida, Yoshifumi, Katakawa, Kei, Motonaga, Shin-Ichiro, Kimura, Yasunori, Iwao, Hiromu, Kondo
Publikováno v:
Chemicalpharmaceutical bulletin. 67(5)
The aim of this study was to establish a novel approach to in vitro dissolution evaluation using a combination of the paddle method and a dialysis membrane, both to predict the overall in vivo performance of tacrolimus microspheres and also to identi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::3ab524a32c8728397b03077d673cc0d0
https://pubmed.ncbi.nlm.nih.gov/31061372
https://pubmed.ncbi.nlm.nih.gov/31061372