VOLUME 13, ISSUE 9 / SEPTEMBER 2021
Editorial
SEPTEMBER 2021
Towards a more patient-centric assessment of immunogenicity for low-risk biologics in immuno-oncology clinical trials
- Mohamed Hassanein,
- Ying Wang,
- Donghua Yin &
- Daniel Baltrukonis
- Pages:1309–1312
- Published Online:2 September 2021
White Paper
SEPTEMBER 2021
Cloud solutions for GxP laboratories: considerations for data storage
- Scott Davis,
- Joel Usansky,
- Shibani Mitra-Kaushik
, - John Kellie,
- Kimberly Honrine,
- Eric Woolf,
- Jeb Adams,
- Ryan Kelly,
- John Evens,
- Samuel Pine,
- Hannes Hochreiner,
- Michelle Dawes,
- Jason Kentner &
- Sean Crawford
- Pages:1313–1321
- Published Online:13 September 2021
Special Report
SEPTEMBER 2021
A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications for the assessment of target and antidrug antibody effects
- Dana T Hackel,
- Theingi M Thway,
- Shiew Mei Huang &
- Yow-Ming C Wang
- Pages:1323–1332
- Published Online:13 September 2021
Research Article
SEPTEMBER 2021
High-sensitivity workflow for LC–MS-based analysis of GalNAc-conjugated oligonucleotides: a case study
- Aaron R Ledvina,
- Matthew Ewles,
- Paul Severin,
- David Good &
- Cecilia Arfvidsson
- Pages:1343–1353
- Published Online:2 September 2021
Review
SEPTEMBER 2021
Cytochrome P450 enzymes: a review on drug metabolizing enzyme inhibition studies in drug discovery and development
- Siva Nageswara Rao Gajula ,
- Megha Sajakumar Pillai,
- Gananadhamu Samanthula &
- Rajesh Sonti
- Pages:1355–1378
- Published Online:14 September 2021