Works by Abend, Andreas

Results: 15

Development of an ultra‐high‐performance liquid chromatography‐charged aerosol detection/UV method for the quantitation of linear polyethylenimines in oligonucleotide polyplexes.

Published in:

Journal of Separation Science, 2020, v. 43, n. 20, p. 3876, doi. 10.1002/jssc.202000414

By:

Socia, Adam;
Liu, Yong;
Zhao, Yuejie;
Abend, Andreas;
Wuelfing, W. Peter

Publication type:

Article

Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series.

Published in:

Pharmaceutics, 2022, v. 14, n. 5, p. 1010, doi. 10.3390/pharmaceutics14051010

By:

McAllister, Mark;
Flanagan, Talia;
Cole, Susan;
Abend, Andreas;
Kotzagiorgis, Evangelos;
Limberg, Jobst;
Mead, Heather;
Mangas-Sanjuan, Victor;
Dickinson, Paul A.;
Moir, Andrea;
Pepin, Xavier;
Zhou, Diansong;
Tistaert, Christophe;
Dokoumetzidis, Aristides;
Anand, Om;
Le Merdy, Maxime;
Turner, David B.;
Griffin, Brendan T.;
Darwich, Adam;
Dressman, Jennifer

Publication type:

Article

Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives.

Published in:

Pharmaceutics, 2020, v. 12, n. 1, p. 19, doi. 10.3390/pharmaceutics12010019

By:

McAllister, Mark;
Flanagan, Talia;
Boon, Karin;
Pepin, Xavier;
Tistaert, Christophe;
Jamei, Masoud;
Abend, Andreas;
Kotzagiorgis, Evangelos;
Mackie, Claire

Publication type:

Article

Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms.

Published in:

AAPS PharmSciTech, 2014, v. 15, n. 1, p. 198, doi. 10.1208/s12249-013-0047-x

By:

Alsante, Karen M.;
Kim Huynh-Ba;
Baertschi, Steven W.;
Reed, Robert A.;
Landis, Margaret S.;
Kleinman, Mark H.;
Foti, Christopher;
Rao, Venkatramana M.;
Meers, Paul;
Abend, Andreas;
Reynolds, Daniel W.;
Joshi, Biren K.

Publication type:

Article

Commentary on “The Effect of Sampling Cannula on In Vitro Dissolution Testing with USP Paddle Method”.

Published in:

AAPS Journal, 2024, v. 26, n. 4, p. 1, doi. 10.1208/s12248-024-00926-6

By:

Abend, Andreas;
Stippler, Erika;
Kühl, Nikos;
Externbrink, Anna;
Smith, Kieran Lewis;
Mann, James

Publication type:

Article

Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00795-5

By:

Abend, Andreas M.;
Hoffelder, Thomas;
Cohen, Michael J.;
Van Alstine, Leslie;
Diaz, Dorys Argelia;
Fredro-Kumbaradzi, Emilija;
Reynolds, James;
Zheng, Yanbing;
Witkowski, Krista;
Heimbach, Tycho

Publication type:

Article

DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00697-y

By:

Hoffelder, Thomas;
Leblond, David;
Van Alstine, Leslie;
Diaz, Dorys Argelia;
Suarez-Sharp, Sandra;
Witkowski, Krista;
Altan, Stan;
Reynolds, James;
Bergeron, Zachary;
Lief, Kevin;
Zheng, Yanbing;
Abend, Andreas

Publication type:

Article

Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00691-4

By:

Abend, Andreas M.;
Zhang, Limin;
Fredro-Kumbaradzi, Emilija;
Hoffelder, Thomas;
Cohen, Michael J.;
Anand, Om;
Delvadia, Poonam;
Mandula, Haritha;
Zhang, Zhen;
Kotzagiorgis, Evangelos;
Lum, Susan;
Pereira, Victor Gomes;
Barker, Amy;
Lavrich, David;
Kraemer, Johannes;
Sharp-Suarez, Sandra

Publication type:

Article

In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report.

Published in:

AAPS Journal, 2020, v. 22, n. 4, p. 1, doi. 10.1208/s12248-020-00458-9

By:

Suarez-Sharp, Sandra;
Abend, Andreas;
Hoffelder, Thomas;
Leblond, David;
Delvadia, Poonam;
Kovacs, Elisabeth;
Diaz, Dorys Argelia

Publication type:

Article

Biowaiver Applications in Support of a Polymorph During Late-Stage Clinical Development of Verubecestat—Current Challenges and Future Opportunities for Global Regulatory Alignment.

Published in:

AAPS Journal, 2020, v. 22, n. 1, p. 1, doi. 10.1208/s12248-019-0396-9

By:

Abend, Andreas;
Xiong, Leah;
Zhang, Xiaohua;
Frankenfeld, Celeste;
Kesisoglou, Filippos;
Reuter, Kevin;
Kotwal, Pramod

Publication type:

Article

Dissolution Testing in Drug Product Development: Workshop Summary Report.

Published in:

AAPS Journal, 2019, v. 21, n. 2, p. 1, doi. 10.1208/s12248-018-0288-4

By:

Abend, Andreas;
Curran, David;
Kuiper, Jesse;
Lu, Xujin;
Li, Hanlin;
Hermans, Andre;
Kotwal, Pramod;
Diaz, Dorys A.;
Cohen, Michael J.;
Zhang, Limin;
Stippler, Erika;
Drazer, German;
Lin, Yiqing;
Raines, Kimberly;
Yu, Lawrence;
Coutant, Carrie A.;
Grady, Haiyan;
Krämer, Johannes;
Pope-Miksinski, Sarah;
Suarez-Sharp, Sandra

Publication type:

Article

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report.

Published in:

AAPS Journal, 2018, v. 20, n. 6, p. 1, doi. 10.1208/s12248-018-0252-3

By:

Suarez-Sharp, Sandra;
Cohen, Michael;
Kesisoglou, Filippos;
Abend, Andreas;
Marroum, Patrick;
Delvadia, Poonam;
Kotzagiorgis, Evangelos;
Li, Min;
Nordmark, Anna;
Bandi, Nagesh;
Sjögren, Erik;
Babiskin, Andrew;
Heimbach, Tycho;
Kijima, Shinichi;
Mandula, Haritha;
Raines, Kimberly;
Seo, Paul;
Zhang, Xinyuan

Publication type:

Article

Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report.

Published in:

AAPS Journal, 2018, v. 20, n. 3, p. 1, doi. 10.1208/s12248-018-0213-x

By:

Abend, Andreas;
Heimbach, Tycho;
Cohen, Michael;
Kesisoglou, Filippos;
Pepin, Xavier;
Suarez-Sharp, Sandra

Publication type:

Article

Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms.

Published in:

AAPS Journal, 2017, v. 19, n. 6, p. 1537, doi. 10.1208/s12248-017-0117-1

By:

Hermans, Andre;
Abend, Andreas;
Kesisoglou, Filippos;
Flanagan, Talia;
Cohen, Michael;
Diaz, Dorys;
Mao, Y.;
Zhang, Limin;
Webster, Gregory;
Lin, Yiqing;
Hahn, David;
Coutant, Carrie;
Grady, Haiyan

Publication type:

Article

Dioldehydratase Binds Coenzyme B.

Published in:

Angewandte Chemie International Edition, 1998, v. 37, n. 5, p. 625, doi. 10.1002/(SICI)1521-3773(19980316)37:5<625::AID-ANIE625>3.0.CO;2-4

By:

Abend, Andreas;
Nitsche, Rainer;
Bandarian, Vahe;
Stupperich, Erhard;
Rétey, János

Publication type:

Article