Bioanalytical strategies in drug discovery and development

被引：10
作者：
Thakur, Aarzoo [1 ,2 ]
Tan, Zhiyuan [3 ]
Kameyama, Tsubasa [4 ,5 ]
El-Khateeb, Eman [6 ,7 ]
Nagpal, Shakti [8 ]
Malone, Stephanie [9 ]
Jamwal, Rohitash [10 ]
Nwabufo, Chukwunonso K. [11 ]
机构：
[1] Agcy Sci Technol & Res, Innovat Food & Chem Safety, Singapore, Singapore
[2] Agcy Sci Technol & Res, Skin Res Inst Singapore, Singapore, Singapore
[3] dMed Clinipace, Dept Early Clin Dev, Shanghai, Peoples R China
[4] Univ Calif San Francisco, Sch Pharm, Dept Bioengn & Therapeut Sci, San Francisco, CA USA
[5] Univ Calif San Francisco, Sch Med, Dept Bioengn & Therapeut Sci, San Francisco, CA USA
[6] Univ Manchester, Ctr Appl Pharmacokinet Res, Manchester, Lancs, England
[7] Tanta Univ, Fac Pharm, Clin Pharm Dept, Tanta, Egypt
[8] Natl Univ Singapore, Fac Sci, Dept Pharm, Singapore, Singapore
[9] Theravance Biopharma US Inc, San Francisco, CA USA
[10] Univ Rhode Isl, Coll Pharm, Kingston, RI 02881 USA
[11] Gilead Alberta ULC, Edmonton, AB T6S 1A1, Canada
来源：
DRUG METABOLISM REVIEWS | 2021年 / 53卷 / 03期
关键词：
Bioanalysis; drug discovery and development; small molecule drugs; biologics; LC-MS; MS; LIQUID-LIQUID-EXTRACTION; THERAPEUTIC MONOCLONAL-ANTIBODIES; LC-MS/MS METHOD; SPECTROMETRY-BASED QUANTIFICATION; ORTHOGONAL ARRAY OPTIMIZATION; SAMPLE PREPARATION TECHNIQUES; RESOLUTION MASS-SPECTROMETRY; HIGH-THROUGHPUT; NANO-SURFACE; HUMAN PLASMA;
D O I：
10.1080/03602532.2021.1959606
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
A reliable, rapid, and effective bioanalytical method is essential for the determination of the pharmacokinetic, pharmacodynamic, and toxicokinetic parameters that inform the safety and efficacy profile of investigational drugs. The overall goal of bioanalytical method development is to elucidate the procedure and operating conditions under which a method can sufficiently extract, qualify, and/or quantify the analyte(s) of interest and/or their metabolites for the intended purpose. Given the difference in the physicochemical properties of small and large molecule drugs, different strategies need to be adopted for the development of an effective and efficient bioanalytical method. Herein, we provide an overview of different sample preparation strategies, analytical platforms, as well as procedures for achieving high throughput for bioanalysis of small and large molecule drugs.
引用
收藏
页码：434 / 458
页数：25
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