Works matching IS 15507416 AND DT 2021 AND VI 23 AND IP 6

Results: 13

Understanding Drug Delivery to the Brain Using Liposome-Based Strategies: Studies that Provide Mechanistic Insights Are Essential.

Published in:

AAPS Journal, 2021, v. 23, n. 6, p. 1, doi. 10.1208/s12248-021-00648-z

By:

Juhairiyah, Firda;
de Lange, Elizabeth C. M.

Publication type:

Article

Understanding Drug Delivery to the Brain Using Liposome-Based Strategies: Studies that Provide Mechanistic Insights Are Essential.

Published in:

AAPS Journal, 2021, v. 23, n. 6, p. 1, doi. 10.1208/s12248-021-00648-z

By:

Juhairiyah, Firda;
de Lange, Elizabeth C. M.

Publication type:

Article

ICH Q10 Pharmaceutical Quality System Guidance: Understanding Its Impact on Pharmaceutical Quality.

Published in:

AAPS Journal, 2021, v. 23, n. 6, p. 1, doi. 10.1208/s12248-021-00657-y

By:

VanDuyse, Sean A.;
Fulford, Michael J.;
Bartlett, Michael G.

Publication type:

Article

Pharmacokinetics of Monoclonal Antibody and Antibody Fragments in the Mouse Eye Following Systemic Administration.

Published in:

AAPS Journal, 2021, v. 23, n. 6, p. 1, doi. 10.1208/s12248-021-00647-0

By:

Bussing, David;
Li, Zhe;
Li, Yingyi;
Chang, Hsuan-Ping;
Chang, Hsueh-Yuan;
Guo, Leiming;
Verma, Ashwni;
Shah, Dhaval K.

Publication type:

Article

Immunogenicity Risk Assessment for Multi-specific Therapeutics.

Published in:

AAPS Journal, 2021, v. 23, n. 6, p. 1, doi. 10.1208/s12248-021-00642-5

By:

Kroenke, Mark A.;
Milton, Mark N.;
Kumar, Seema;
Bame, Eris;
White, Joleen T.

Publication type:

Article

A Systematic Approach for Liposome and Lipodisk Preclinical Formulation Development by Microfluidic Technology.

Published in:

AAPS Journal, 2021, v. 23, n. 6, p. 1, doi. 10.1208/s12248-021-00651-4

By:

Levy, Elizabeth S.;
Yu, Jesse;
Estevez, Alberto;
Mao, Jialin;
Liu, Liling;
Torres, Elizabeth;
Leung, Dennis;
Yen, Chun-Wan

Publication type:

Article

Correction to: Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies.

Published in:

2021

By:

McMahon, Megan E.;
Abbott, Alexander;
Babayan, Yelizaveta;
Carhart, Jenny;
Chen, Chi-wan;
Debie, Elke;
Fu, Mingkun;
Hoaglund-Hyzer, Cherokee;
Lennard, Andrew;
Li, Hanlin;
Mazzeo, Tony;
McCaig, Lori;
Pischel, Sylvine;
Qiu, Fenghe;
Stephens, Dennis;
Timpano, Robert;
Webb, Debra;
Wolfe, Chad;
Woodlief, Kayla;
Wu, Yan

Publication type:

Correction Notice

Bioanalytical Challenges due to Prior Checkpoint Inhibitor Exposure: Interference and Mitigation in Drug Concentration and Immunogenicity Assays.

Published in:

AAPS Journal, 2021, v. 23, n. 6, p. 1, doi. 10.1208/s12248-021-00643-4

By:

Dengler, Andrew F.;
Weiss, Rachel;
Truong, Tiffany;
Irvin, Susan C.;
Gadhia, Nidhi;
Hassanein, Mohamed;
Georgaros, Camille;
Taylor, Jessica-Ann;
Paccaly, Anne;
Sumner, Giane;
Andisik, Matthew D.;
Torri, Albert;
Partridge, Michael A.

Publication type:

Article

Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies.

Published in:

AAPS Journal, 2021, v. 23, n. 6, p. 1, doi. 10.1208/s12248-021-00641-6

By:

McMahon, Megan E.;
Abbott, Alexander;
Babayan, Yelizaveta;
Carhart, Jenny;
Chen, Chi-wan;
Debie, Elke;
Fu, Mingkun;
Hoaglund-Hyzer, Cherokee;
Lennard, Andrew;
Li, Hanlin;
Mazzeo, Tony;
McCaig, Lori;
Pischel, Sylvine;
Qiu, Fenghe;
Stephens, Dennis;
Timpano, Robert;
Webb, Debra;
Wolfe, Chad;
Woodlief, Kayla;
Wu, Yan

Publication type:

Article

Cluster Gauss–Newton and CellNOpt Parameter Estimation in a Small Protein Signaling Network of Vorinostat and Bortezomib Pharmacodynamics.

Published in:

AAPS Journal, 2021, v. 23, n. 6, p. 1, doi. 10.1208/s12248-021-00640-7

By:

Niu, Jin;
Nguyen, Van Anh;
Ghasemi, Mohammad;
Chen, Ting;
Mager, Donald E.

Publication type:

Article

Understanding In Vivo Dissolution of Immediate Release (IR) Solid Oral Drug Products Containing Weak Acid BCS Class 2 (BCS Class 2a) Drugs.

Published in:

AAPS Journal, 2021, v. 23, n. 6, p. 1, doi. 10.1208/s12248-021-00639-0

By:

Li, Min;
Zhang, Xinwen;
Wu, Di;
Anand, Om;
Chen, Hansong;
Raines, Kimberly;
Yu, Lawrence

Publication type:

Article

Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group.

Published in:

AAPS Journal, 2021, v. 23, n. 6, p. 1, doi. 10.1208/s12248-021-00634-5

By:

Weitzel, Jane;
Pappa, Horacio;
Banik, Gregory M.;
Barker, Amy R.;
Bladen, Elizabeth;
Chirmule, Narendra;
DeFeo, Joseph;
Devine, Jennifer;
Emrick, Steven;
Hout, Taha Kass;
Levy, Michael S.;
Mahlangu, Gugu N.;
Rellahan, Barbara;
Venema, Jaap;
Workman, Wesley

Publication type:

Article

Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays.

Published in:

AAPS Journal, 2021, v. 23, n. 6, p. 1, doi. 10.1208/s12248-021-00628-3

By:

Gorovits, Boris;
Azadeh, Mitra;
Buchlis, George;
Harrison, Travis;
Havert, Mike;
Jawa, Vibha;
Long, Brian;
McNally, Jim;
Milton, Mark;
Nelson, Robert;
O'Dell, Mark;
Richards, Karen;
Vettermann, Christian;
Wu, Bonnie

Publication type:

Article