VOLUME 15, ISSUE 16 / AUGUST 2023
White Paper
AUGUST 2023
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B – Regulatory Agencies’ Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)
- Matt Szapacs,
- Wenying Jian,
- Daniel Spellman,
- Jennifer Cunliffe,
- Elizabeth Verburg,
- Surinder Kaur,
- John Kellie,
- Wenkui Li,
- John Mehl,
- Mark Qian,
- Xiazi Qiu,
- Federico Riccardi Sirtori,
- Anton I. Rosenbaum,
- Tim Sikorski,
- Sekhar Surapaneni,
- Jian Wang,
- Amanda Wilson,
- Jinhui Zhang,
- Yongjun Xue,
- Noah Post,
- Yue Huang,
- Dina Goykhman
Editorial
AUGUST 2023
High-throughput MS for intact protein analysis
- Chang Liu
- Pages:1017–1019
- Published Online:16 August 2023
Bioanalytical Challenge
JULY 2023
A new approach with dried plasma spots: a rapid determination of antidepressants and antipsychotics by fast GC–MS
- Giovanna Cristiano de Gouveia ,
- Bruno Pereira dos Santos ,
- Gabriela Ramos Borges ,
- Viviane Cristina Sebben ,
- Sarah Eller &
- Tiago Franco de Oliveira
- Pages:1021–1032
- Published Online:11 July 2023
Research Article
JULY 2023
In vitro study and pharmacokinetic evaluation of sitagliptin phosphate enantiomers in rat plasma
- Tatineni Spandana ,
- Veera VN Goli &
- Bannimath Gurupadayya
- Pages:1033–1047
- Published Online:11 July 2023
Research Article
JULY 2023
Phage-derived anti-idiotype and anti-YTE antibodies in development of MK-1654 pharmacokinetic and immune response assays
- April Li,
- Michael Swanson,
- Nicole Sullivan,
- Ying Homan,
- Debbie Nahas,
- Shreya Mukhopadhyay,
- Hualin Helen Li,
- Yu Cao,
- Weifeng Xu,
- Huaping Tang,
- Kalpit A Vora &
- Zhifeng Chen
- Pages:1049–1067
- Published Online:29 July 2023