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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
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
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
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
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
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
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
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

Found: 13