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Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters: Concepts, Methods and Translational Sciences 2nd edition [Pehme köide]

Edited by (Principal Scientist, Department of Drug Metabolism and Pharmacokinetics, Genentech Inc.), Edited by (Director of DMPK, Takeda Pharmaceutical International Co., Cambridge, MA, USA)
  • Formaat: Paperback / softback, 708 pages, kõrgus x laius: 235x191 mm, kaal: 1460 g, 120 illustrations (10 in full color); Illustrations, unspecified
  • Ilmumisaeg: 10-Jul-2020
  • Kirjastus: Elsevier Science Publishing Co Inc
  • ISBN-10: 0128200189
  • ISBN-13: 9780128200186
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Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters: Concepts, Methods and Translational Sciences 2nd editionSuurem pilt
  • Formaat: Paperback / softback, 708 pages, kõrgus x laius: 235x191 mm, kaal: 1460 g, 120 illustrations (10 in full color); Illustrations, unspecified
  • Ilmumisaeg: 10-Jul-2020
  • Kirjastus: Elsevier Science Publishing Co Inc
  • ISBN-10: 0128200189
  • ISBN-13: 9780128200186
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Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters, Second Edition, is completely updated to provide an overview of the last decade’s numerous advances in analytical technologies for detection and quantification of drugs, metabolites, and biomarkers. This new edition goes beyond LC-MS and features all-new chapters on how to evaluate drug absorption, distribution, metabolism, and excretion, potential for hepatic and renal toxicity, immunogenicity of biotherapeutics and translational tools for predicting human dosage, safety and efficacy of small molecules and biologics. This book will be an important handbook and desk reference for pharmacologists, toxicologists, clinical scientists, and students interested in the fields of pharmacology, biochemistry, and drug metabolism.

  • Four sections in the book with 24 chapters give readers an overview of state-of-the-art techniques for identifying and quantifying drugs, metabolites and biomarkers, including a chapter on new approaches for quantification of enzymes and transporters in different tissues
  • Focuses on the role of drug metabolism enzymes, transporters in disposition and drug-drug interactions, as well as strategies for evaluating drug metabolism and safety using advanced liver and kidney models. Discussions on immunogenicity risks of biologics and their evaluation methods have been included
  • Includes several chapters on advanced translational sciences to predict human dosage, pharmacokinetics and efficacy for small molecules and biotherapeutics
  • All chapters are written by experts with a wide range of practical experience from the industry and academia
Contributors xi
Foreword xv
Preface xix
I Techniques for identifying and quantifying drugs and metabolites
1 Bioanalysis of small and large molecule drugs, metabolites, and biomarkers by LC-MS
Naidong Weng
Shefali Patel
Wenying Jian
1 Introduction
3(1)
2 Complexity of contemporary bioanalysis
4(2)
3 Bioanalytical requirements for supporting discovery, nonclinical, and clinical studies
6(1)
4 Current regulatory landscape for bioanalysis
6(1)
5 General considerations for bioanalysis for sample collection
7(2)
6 Diagnosis and mitigation of nonspecific adsorption loss for urine bioanalysis
9(1)
7 Tissue bioanalysis
10(1)
8 Managing unstable metabolites such as acyl glucuronide
11(1)
9 General considerations for bioanalysis for extraction, chromatography, and MS detection
11(3)
10 Selected applications for LC-MS bioanalysis
14(18)
11 Conclusion and future perspective
32(1)
References
33(7)
2 Recent advances in mass spectrometric and other analytical techniques for the identification of drug metabolites
Jose Castro-Perez
Chandra Prakash
1 Introduction
40(1)
2 Sample preparation strategies
41(3)
3 Optical detectors and chromatographic separation techniques
44(1)
4 Different types of Ionization techniques and mass spectrometric scan functions
45(11)
5 Wet chemistry techniques combined with MS
56(8)
6 Conclusion and future trends
64(1)
References
65(8)
3 High-resolution mass spectrometry-based data acquisition and data-mining technologies for detecting and characterizing drug metabolites and traditional Chinese medicine components
Tingting Cai
Caisheng Wu
Qian Ruan
Shuguang Ma
Mingshe Zhu
1 Introduction
73(3)
2 HRMS-based data acquisition technologies for metabolite identification
76(12)
3 HRMS-based data-processing techniques for metabolite identification
88(8)
4 Applications of HRMS technologies in metabolite identification experiments
96(6)
5 Detection and structural characterization of traditional Chinese medicine components in biological systems
102(7)
6 Conclusion and future perspectives
109(1)
Acknowledgments
110(1)
References
111(8)
4 Methods for metabolite generation and characterization by NMR
Liam Evans
Richard Phipps
Julia Shanu-Wilson
Jonathan Steele
Stephen Wrigley
1 Introduction
119(2)
2 Methods for scaled-up production of drug metabolites
121(15)
3 Purification and structure elucidation of metabolites
136(9)
4 Conclusions and future direction
145(1)
Acknowledgments
146(1)
References
147(4)
5 Application of SFC for bioanalysis
Jan Felix Joseph
Maria Kristina Parr
1 Introduction
151(3)
2 Considerations for SFC method development
154(3)
3 Detection in SFC
157(2)
4 Sample preparation
159(1)
5 Examples
160(15)
6 Conclusion
175(1)
References
175(10)
6 AMS in drug development: Exploring the current utility of AMS and future opportunities for absolute bioavailability and ADME investigations
Graeme C. Young
Marie Croft
1 Introduction
185(1)
2 Introduction of the AMS technique
186(7)
3 Clinical study design definitions
193(2)
4 First drug development clinical study application of AMS
195(1)
5 Hybrid studies (macrotracer)
196(2)
6 Low tracer dose studies
198(1)
7 Concomitant microtracer: Design and delivery
199(3)
8 Improved efficiencies in drug development
202(2)
9 Conclusions
204(1)
10 Future perspectives
205(1)
References
206(7)
II Drug metabolism enzymes, transporters and drug-drug interaction
7 Using in vitro methods to determine P450s responsible for metabolism and discrimination from other oxidative pathways
Adrian J. Fretland
Tashinga E. Bapiro
Barry Jones
Roshini Markandu
Alexandra L. Orton
Venkatesh Pilla Reddy
1 Introduction
213(2)
2 Recombinant P450 assays
215(3)
3 Human liver microsome-based methods
218(5)
4 P450 vs FMO/AO metabolism
223(4)
5 Determination of fmCYP3A
227(2)
6 Regulatory guidance/risk assessment/examples
229(3)
7 Conclusion and future directions
232(1)
References
232(5)
8 Evaluation of the clearance mechanism of non-CYP-mediated drug metabolism and DDI as a victim drug
Anima Ghosal
1 Introduction
237(1)
2 UDP-glucuronosyltransferase (UGT)
238(7)
3 Flavin monooxygenase (FMO)
245(3)
4 Monoamine oxidase (MAO)
248(3)
5 Aldehyde oxidase
251(2)
6 Xanthine oxidase (XO)
253(3)
7 Carboxylesterases (CES)
256(5)
8 Aldo-keto reductase (AKR)
261(3)
9 Future trends
264(3)
10 Conclusion
267(1)
Acknowledgment
267(1)
References
267(6)
9 In vitro characterization and in vitro to in vivo predictions of drug-drug interactions
Nina Isoherranen
Robert S. Fori
1 Introduction
273(5)
2 In vitro assessment of metabolism-based drug interaction potential
278(14)
3 Quantitative in vitro to in vivo predictions
292(8)
4 Clinical drug interaction assessment
300(1)
5 Conclusions
301(1)
References
301(10)
10 Role of transporters in drug disposition and drug-drug interactions
Xiaomin Liang
Kelly MacLennan Staiger
Ellen Riddle
Jia Hao
Yurong Lai
1 Introduction
311(1)
2 Overview of membrane transporters
312(6)
3 Clinical significance of transporter-mediated drug disposition and drug-drug interactions
318(2)
4 Tools to assess transporter liabilities in drug discovery and development
320(6)
5 Regulatory landscape of evaluating transporter-mediated drug interactions
326(3)
6 Challenges and perspectives on transporter-mediated drug interactions
329(2)
References
331(9)
11 Mechanisms and clinical relevance of pharmacokinetic-based clinical drug-drug interactions for drugs recently approved by the US Food and Drug Administration
Jingjing Yu
Ichiko D. Petrie
Sophie M.A. Argon
Katie H. Owens
Isabelle Ragueneau-Majlessi
1 Introduction
340(1)
2 Enzyme-mediated DDIs
341(8)
3 Transporter-mediated DDIs
349(3)
4 PBPK modeling and simulations in DDI prediction
352(1)
5 PGx studies
353(1)
6 Other mechanisms: Absorption-based DDIs
354(2)
7 Conclusion
356(1)
References
356(3)
12 Quantifying drug metabolizing enzymes and transporters by LC-MS/MS proteomics
Haeyoung Zhang
Abdul Basit
Bhagwat Prasad
1 Introduction
359(2)
2 Basic workflow of DMET quantitative proteomics
361(9)
3 Factors affecting DMET protein quantification
370(1)
4 Optimized quantitative analysis approaches
371(3)
5 Applications of quantitative DMET proteomics
374(3)
6 Conclusion
377(1)
References
378(9)
13 Protein drug-drug interactions for therapeutic modalities
Liming Liu
Raymond Evers
Diana Montgomery
1 Introduction
387(2)
2 DDI mechanisms
389(4)
3 TP-DDI observed in clinical studies
393(8)
4 Potential DDI between emerging modalities
401(3)
5 Risk assessment and strategies to evaluate potential TP-DDI
404(3)
6 Conclusion and future perspectives
407(1)
References
408(11)
III Strategy related to drug metabolism and safety
14 Metabolites in safety testing (MIST)
Simone Schadt
Filipe Lopes
Simon Hauri
Axel Pahler
Andreas Brink
1 Introduction
419(2)
2 Technological approaches for MIST assessment
421(8)
3 A typical MIST strategy
429(4)
4 Metabolite safety assessment beyond the MIST guidance documents
433(1)
5 Conclusion and future outlook
434(1)
References
435(4)
15 The use of stable isotopes in drug metabolism studies
Kevin Johnson
Hoa Le
S. Cyrus Khojasteh
1 Introduction
439(1)
2 Use of stable labels for metabolite detection and identification
440(5)
3 Deuterated drugs
445(12)
4 Conclusions and future perspectives
457(1)
References
457(4)
16 Assessment of stereoselectivity in pharmacology, toxicology, and drug metabolism
Lushan Yu
Su Zeng
1 Introduction
461(1)
2 Regulatory considerations on developing chiral drugs
462(1)
3 Stereoselectivity in pharmacodynamics
463(2)
4 Stereoselectivity in pharmacokinetics and ADME properties
465(6)
5 Stereoselectivity in toxicity
471(2)
6 Chiral inversion mechanisms
473(2)
7 Stereoselective analytical methods
475(5)
8 Conclusion
480(1)
References
480(7)
17 Progress of derisking strategies for drug-induced liver injury (DILI) in the last two decades
Kaushik Mitra
1 Introduction
487(1)
2 Challenges in predicting DILI
487(9)
3 Mitochondrial impairment
496(1)
4 Transporter inhibition
497(2)
5 Overarching derisking approaches independent of mechanism
499(4)
6 Summary
503(1)
References
504(3)
18 Predictive and translational models for renal drug safety evaluation
Piyush Bajaj
Rosalinde Masereeuw
J. Eric McDuffie
Matthew P. Wagoner
1 Background and introduction
507(3)
2 2D in vitro models for nephrotoxicity screening
510(4)
3 Emerging models for renal safety screening
514(6)
4 Translatable kidney safety biomarkers
520(3)
5 Context of use of in vitro PTEC models---Mechanistic vs. predictive
523(2)
6 Outlook and future perspectives
525(3)
References
528(7)
19 Immunogenicity: An introduction to its role in the safety and efficacy of biotherapeutics
Christopher Gemski
Satyajeet Haridas
1 Introduction
535(1)
2 Overview of immunogenicity
536(1)
3 Overview of immune response mechanisms
537(5)
4 Humoral immunogenicity: Overall risk assessment and mitigation strategies
542(4)
5 Cellular immunogenicity risk assessments
546(2)
6 Mitigation strategy and case studies for cellular immunogenicity
548(2)
7
Chapter Summary
550(1)
Acknowledgments
550(1)
References
550(5)
IV Translational sciences
20 Application of genetically modified rodent models in drug discovery and development for translation of clinical ADME properties
Robert S. Jones
Justin Q. Ly
Jae H. Chang
1 Introduction
555(3)
2 Knockout animal models
558(11)
3 Xenobiotic receptor KO models
569(3)
4 Humanized transgenic animal models
572(4)
5 Humanized liver chimeric mouse models
576(8)
6 Conclusions and future perspectives
584(1)
References
585(10)
21 Advances in CRISPR technologies enable novel in vitro tools for ADME studies
Eugene Chia-Te Chen
1 Introduction
595(1)
2 In vitro applications of CRISPR
596(3)
3 Examples of CRISPR application in ADME studies in vitro
599(4)
4 Potential opportunities and limitations for CRISPR applications in ADME studies in vitro
603(2)
References
605(4)
22 In vitro-in vivo extrapolation of human hepatic and renal clearance
Ravindra Varma Alluri
Manthena V.S. Varma
1 Introduction
609(1)
2 ECCS framework to identify rate-determining process for CL
610(2)
3 Current IVIVE approaches to predict clearance
612(13)
4 Conclusions
625(1)
References
625(9)
23 The role of quantitative modeling and simulation in translational science
Venkatesh Pilla Reddy
Andy Z.X. Zhu
1 Introduction
634(1)
2 Pharmacokinetic modeling
635(12)
3 Modeling pharmacodynamic response
647(4)
4 Conclusions
651(1)
References
652(5)
24 PK/PD-driven starting and effective human dose determination for immuno-oncology drugs
Dhaval K. Shah
Farah Al Qaraghuli
Wanying Zhang
1 Introduction
657(2)
2 Dose selection for immune-activating agents
659(3)
3 Dose selection for T-cell engaging bispecific molecules
662(2)
4 Dose selection for emerging class of I-O therapies
664(1)
5 Future directions
665(1)
References
666(3)
Index 669
Dr. Ma is currently a Principal Scientist in the Department of Drug Metabolism and Pharmacokinetics at Genentech Inc. Previously he was a Senior Principal Scientist at Schering-Plough (now Merck) and a Senior Scientist at Amgen. He received his Ph.D. in Analytical Chemistry from Purdue University under the direction of Professor R. Graham Cooks. He also had two years of postdoctoral training in biological mass spectrometry at Vanderbilt University School of Medicine under Professor Richard Caprioli. Dr. Ma has authored 55 research articles in peer-reviewed journals and 4 book chapters, covering broad areas of mass spectrometry and its applications. His current research interests include the development of novel LC/MS-based techniques for metabolite detection and investigation of biotransformation and bioactivation of xenobiotics. Dr. Chowdhury is currently a Director of DMPK at Takeda Pharmaceutical International Co. in Cambridge, MA, responsible for evaluating metabolism, toxicity, and potential for drug-drug interaction due to modulation of activities of metabolizing enzymes and transporters by compounds in discovery and development. Dr. Chowdhury obtained his Ph.D. from the University of Alberta in 1987. After spending a year and a half as a post-doctoral fellow at the University of Toronto, Dr. Chowdhury joined Rockefeller University as a Research Associate in the laboratory of Professor Brian Chait. At Rockefeller University, Dr. Chowdhury was involved in the early stage of the development of atmospheric pressure ionization (API) mass spectrometry. This early research on API led to the introduction of a novel API system for LC/MS. After leaving Rockefeller University, he worked on the applications of liquid chromatography/mass spectrometry techniques at several non-academic organizations, including at Schering-Plough Research Institute (SPRI), where he worked for fifteen years in the Department of Drug Metabolism and Pharmacokinetics. The focus of his research at SPRI was to investigate the biotransformation of drugs in support of drug discovery and development. He was involved with the development and registration of a number of pharmaceuticals including Temodar, Clarinex, Zetia, Noxafil, Nasonex/Asmanex, and Victrelis. Dr. Chowdhury is an author of nearly 100 original publications covering a broad area of drug metabolism and drug-drug interaction and analytical technologies to evaluate them.