Zobrazeno 1 - 10
of 43
pro vyhledávání: '"Rakhi B. Shah"'
Autor:
Cyrus Agarabi, Rakhi B. Shah, Erik K. Read, Mansoor A. Khan, David Awotwe-Otoo, Scott Lute, Kurt Brorson
Publikováno v:
International Journal of Pharmaceutics. 450:70-78
An efficient and potentially scalable technology was evaluated to control the ice nucleation step of the freezing process for a model monoclonal antibody formulation and the effect on process performance and quality attributes of the final lyophilize
Autor:
Alan S. Carlin, Mansoor A. Khan, Yongsheng Yang, Rakhi B. Shah, Lawrence X. Yu, Srikant Bykadi
Publikováno v:
Journal of Pharmaceutical Sciences. 102:1370-1381
The aims of this study were to systematically evaluate the effects of pH levels, phosphate concentrations, and tablet integrity on the phosphate binding profiles of lanthanum carbonate chewable tablets, and to compare the in vitro phosphate binding e
Publikováno v:
Molecular Pharmaceutics. 10:544-550
A conventional human pharmacokinetic (PK) in vivo study is often considered as the "gold standard" to determine bioequivalence (BE) of drug products. However, this BE approach is not always applicable to the products not intended to be delivered into
Autor:
Yellela S.R. Krishnaiah, Rakhi B. Shah, Prashanth Manda, Naresh Pavurala, Usha Katragadda, Mansoor A. Khan, Guodong Fang, Yang Yang, Yongsheng Yang
Publikováno v:
AAPS PharmSciTech. 18(6)
Study objective was to assess skin-to-skin drug transfer potential that may occur due to drug retention in human epidermis (DRE) pretreated with application of estradiol transdermal drug delivery systems (TDDS) and other estradiol transdermal dosage
Autor:
David A. Keire, Rakhi B. Shah, Sau L. Lee, Mansoor A. Khan, Cyrus Agarabi, Lawrence X. Yu, Muhammad J. Habib, Andre Raw, David Awotwe-Otoo
Publikováno v:
The AAPS Journal. 14:619-626
The purpose of this study was to characterize and evaluate differences of protamine sulfate, a highly basic peptide drug, obtained from five different sources, using orthogonal thermal and spectroscopic analytical methods. Thermogravimetric analysis
Autor:
Dayue Chen, Kurt Brorson, Rakhi B. Shah, Erik K. Read, Daniel Strauss, Adith Venkiteshwaran, Scott Lute, A Kreuzman, George Miesegaes, Parviz Ayazi Shamlou
Publikováno v:
Biotechnology and Bioengineering. 109:2048-2058
Traditionally, post-production culture harvest capture of therapeutic monoclonal antibodies (mAbs) is performed using Protein A chromatography. We investigated the efficiency and robustness of cation exchange chromatography (CEX) in an effort to eval
Autor:
Rakhi B. Shah, David Awotwe-Otoo, Muhammad J. Habib, Cyrus Agarabi, Sau Lee, Patrick J. Faustino, Mansoor A. Khan
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 62:61-67
The purpose of this study was to develop a robust reverse phase-HPLC method for the separation of hydrolyzed protamine sulfate peptides using a quality by design approach. A Plackett-Burman experimental design was utilized to screen the effects of mo
Publikováno v:
AAPS PharmSciTech. 12:442-448
As stipulated by ICH Q8 R2 (1), prediction of critical process parameters based on process modeling is a part of enhanced, quality by design approach to product development. In this work, we discuss a Bayesian model for the prediction of primary dryi
Autor:
Jarrod S. Collier, Arthur Bryant, Vilayat A. Sayeed, Muhammad J. Habib, Rakhi B. Shah, Mansoor A. Khan
Publikováno v:
AAPS PharmSciTech. 11:1359-1367
Levothyroxine is a narrow therapeutic index, and to avoid adverse effect associated with under or excessive dosage, the dose response is carefully titrated. The tablets are marketed with a score providing an option to split. However, there are no sys
Autor:
Andre Raw, Yongsheng Yang, Mansoor A. Khan, Patrick J. Faustino, Rakhi B. Shah, Lawrence X. Yu
Publikováno v:
Journal of Pharmaceutical Sciences. 99:142-153
A high performance gel permeation chromatography (HP-GPC) method was developed, validated and used to determine the molecular weight (MW) of sodium ferric gluconate following various stress conditions. The intra-day accuracy (90-103%), intra-day prec