Búsqueda | Biblioteca Virtual en Salud

1.

Assessing Physicochemical Stability of Monoclonal Antibodies in a Simulated Subcutaneous Environment.

Jogdeo, Chinmay M; Bhattacharya, Deep S; Lin, Vicky; Kolhe, Parag; Badkar, Advait.

J Pharm Sci ; 113(7): 1854-1864, 2024 Jul.

Artículo en Inglés | MEDLINE | ID: mdl-38341129

2.

A Quality by Design Approach to Microbial Retention Validation.

Leahy, Annie; Juneau, Jennifer; Souza, Kathleen; Miller, Corinne; Nguyen, Nhung; Lutz, Herb; Kolhe, Parag.

PDA J Pharm Sci Technol ; 77(1): 18-26, 2023.

Artículo en Inglés | MEDLINE | ID: mdl-35840346

3.

Laser Measurement and Numerical Simulation of Elastomer Stopper Motion during High-Altitude Shipping of Pharmaceutical Syringes.

Roffi, Kirk; Siddiqui, Naveed; Portelli, Samantha; Sharma, Divya; Juneau, Jennifer; Kolhe, Parag; Badkar, Advait.

PDA J Pharm Sci Technol ; 77(6): 449-471, 2023 Dec 07.

Artículo en Inglés | MEDLINE | ID: mdl-37451836

4.

Effects of Transportation of IV Bags Containing Protein Formulations Via Hospital Pneumatic Tube System: Particle Characterization by Multiple Methods.

Linkuviene, Vaida; Ross, Emma L; Crawford, Lindsey; Weiser, Sarah E; Man, Damen; Kay, Stephen; Kolhe, Parag; Carpenter, John F.

J Pharm Sci ; 111(4): 1024-1039, 2022 04.

Artículo en Inglés | MEDLINE | ID: mdl-35093336

5.

Frozen state storage instability of a monoclonal antibody: aggregation as a consequence of trehalose crystallization and protein unfolding.

Singh, Satish K; Kolhe, Parag; Mehta, Anjali P; Chico, Steven C; Lary, Alanta L; Huang, Min.

Pharm Res ; 28(4): 873-85, 2011 Apr.

Artículo en Inglés | MEDLINE | ID: mdl-21213025

6.

Development of biotechnology products in pre-filled syringes: technical considerations and approaches.

Badkar, Advait; Wolf, Amanda; Bohack, Leigh; Kolhe, Parag.

AAPS PharmSciTech ; 12(2): 564-72, 2011 Jun.

Artículo en Inglés | MEDLINE | ID: mdl-21538214

7.

Control Strategy Approach for a Well-Characterized Vaccine Drug Product.

Kolhe, Parag; Sunasara, Khurram; Lewis, Lavinia; Bailey Piatchek, Michele; Rodriguez, Roberto; Arch-Douglas, Katherine.

PDA J Pharm Sci Technol ; 74(2): 213-228, 2020.

Artículo en Inglés | MEDLINE | ID: mdl-31519784

8.

A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products.

Hubert, Mario; Yang, Dennis T; Kwok, Stanley C; Rios, Anacelia; Das, Tapan K; Patel, Ankit; Wuchner, Klaus; Antochshuk, Valentyn; Junge, Friederike; Bou-Assaf, George M; Cao, Shawn; Saggu, Miguel; Montrond, Luis; Afonina, Nataliya; Kolhe, Parag; Loladze, Vakhtang; Narhi, Linda.

J Pharm Sci ; 109(1): 830-844, 2020 01.

Artículo en Inglés | MEDLINE | ID: mdl-31647951

9.

Effects of branching architecture and linker on the activity of hyperbranched polymer-drug conjugates.

Perumal, Omathanu; Khandare, Jayant; Kolhe, Parag; Kannan, Sujatha; Lieh-Lai, Mary; Kannan, Rangaramanujam M.

Bioconjug Chem ; 20(5): 842-6, 2009 May 20.

Artículo en Inglés | MEDLINE | ID: mdl-19402625

10.

Contribution of Intravenous Administration Components to Subvisible and Submicron Particles Present in Administered Drug Product.

Pollo, Mark; Mehta, Anjali; Torres, Kate; Thorne, Daniel; Zimmermann, Daniel; Kolhe, Parag.

J Pharm Sci ; 108(7): 2406-2414, 2019 07.

Artículo en Inglés | MEDLINE | ID: mdl-30849460

11.

Ex Situ and In Situ Characterization of Vaccine Suspensions in Pre-Filled Syringes.

Lewis, Lavinia M; Guo, Jianxin; Torres, Ekaterina; Wang, Jijun; Billones, Hilbert; Kolhe, Parag; Young, Anthony L; Bates, David; Parker, Andrew; Rigby-Singleton, Shellie.

J Pharm Sci ; 106(8): 2163-2167, 2017 08.

Artículo en Inglés | MEDLINE | ID: mdl-28465152

12.

Preparation, cellular transport, and activity of polyamidoamine-based dendritic nanodevices with a high drug payload.

Kolhe, Parag; Khandare, Jayant; Pillai, Omathanu; Kannan, Sujatha; Lieh-Lai, Mary; Kannan, Rangaramanujam M.

Biomaterials ; 27(4): 660-9, 2006 Feb.

Artículo en Inglés | MEDLINE | ID: mdl-16054211

13.

The Effect of Shipping Stresses on Vaccine Re-dispersion Time.

Guo, Jianxin; Lewis, Lavinia M; Billones, Hilbert; Torres, Ekaterina; Kolhe, Parag.

J Pharm Sci ; 105(6): 2009-2013, 2016 06.

Artículo en Inglés | MEDLINE | ID: mdl-27155766

14.

Molecular attributes of conjugate antigen influence function of antibodies induced by anti-nicotine vaccine in mice and non-human primates.

McCluskie, Michael J; Thorn, Jennifer; Mehelic, Paul R; Kolhe, Parag; Bhattacharya, Keshab; Finneman, Jari I; Stead, David R; Piatchek, Michele Bailey; Zhang, Ningli; Chikh, Ghania; Cartier, Janna; Evans, Dana M; Merson, James R; Davis, Heather L.

Int Immunopharmacol ; 25(2): 518-27, 2015 Apr.

Artículo en Inglés | MEDLINE | ID: mdl-25737198

15.

Drug complexation, in vitro release and cellular entry of dendrimers and hyperbranched polymers.

Kolhe, Parag; Misra, Ekta; Kannan, Rangaramanujam M; Kannan, Sujatha; Lieh-Lai, Mary.

Int J Pharm ; 259(1-2): 143-60, 2003 Jun 18.

Artículo en Inglés | MEDLINE | ID: mdl-12787643

16.

Protein and solute distribution in drug substance containers during frozen storage and post-thawing: a tool to understand and define freezing-thawing parameters in biotechnology process development.

Kolhe, Parag; Badkar, Advait.

Biotechnol Prog ; 27(2): 494-504, 2011.

Artículo en Inglés | MEDLINE | ID: mdl-21302371

17.

Impact of freezing on pH of buffered solutions and consequences for monoclonal antibody aggregation.

Kolhe, Parag; Amend, Elizabeth; Singh, Satish K.

Biotechnol Prog ; 26(3): 727-33, 2010.

Artículo en Inglés | MEDLINE | ID: mdl-20039442

18.

Comparative evaluation of disodium edetate and diethylenetriaminepentaacetic acid as iron chelators to prevent metal-catalyzed destabilization of a therapeutic monoclonal antibody.

Zhou, Shuxia; Zhang, Bo; Sturm, Emily; Teagarden, Dirk L; Schöneich, Christian; Kolhe, Parag; Lewis, Lavinia M; Muralidhara, Bilikallahalli K; Singh, Satish K.

J Pharm Sci ; 99(10): 4239-50, 2010 Oct.

Artículo en Inglés | MEDLINE | ID: mdl-20737631

19.

Sterile Product Development : Formulation, Process, Quality and Regulatory Considerations

Kolhe, Parag.

New York, NY; Springer New York;Imprint: Springer; 2013. 585 p.

Monografía en Inglés | Bibliografia | ID: bib-342352

20.

Synthesis, cellular transport, and activity of polyamidoamine dendrimer-methylprednisolone conjugates.

Khandare, Jayant; Kolhe, Parag; Pillai, Omathanu; Kannan, Sujatha; Lieh-Lai, Mary; Kannan, Rangaramanujam M.

Bioconjug Chem ; 16(2): 330-7, 2005.

Artículo en Inglés | MEDLINE | ID: mdl-15769086

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