Specification of Drug Substances and Products
Development and Validation of Analytical Methods
- 3rd Edition - September 25, 2024
- Editors: Christopher M. Riley, K. Lien Nguyen
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 1 3 4 6 6 - 1
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 1 3 4 6 7 - 8
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Third Edition contains chapters discussing the unique requirements for the unive… Read more
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Third Edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products. This substantially expanded revision of the second edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products.
- Presents critical assessment, potential impact, and application of the recent revisions to ICH guidelines on method validation (Q2) (as well as the latest guideline on Analytical Method Development (Q14), and the special regional requirements in non-ICH regions.
- Addresses comprehensive treatment of the development and validation of analytical methodologies used in the analysis, control, and specification of a variety of different types of dosage forms, ranging from traditional oral solid dosage forms to proteins, nRNA-based drugs, vaccines, and gene therapy. This book will also address drug–device combination
products such as digital drug delivery systems, transdermal systems, and inhalation products. - Presents detailed treatment of latest statistical approaches, including new approaches to the treatment of validation data method, specification setting, and shelf-life prediction (based on stability data).
Scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products. The ideal, or typical reader most likely to read and recommend the book, is concerned with the Chemistry, Manufacturing and Controls (CMC) aspects of drug development. This includes analytical chemists, pre-formulation scientists, formulation scientists, process chemists, process engineers, and pharmaceutical microbiologists, as well those involved in project management, regulatory affairs, quality control and quality assurance
Section I Introduction
1. Introduction
Christopher M. Riley, K. Lien Nguyen, Gerald Gellerman, and Stephan Kirsch
Section II Regulatory considerations and statistical approaches
2. Principles for setting specifications and shelf lives
Laura Pack, Christopher M. Riley, and Kimloan Huynh-Ba
3. Stability studies: General regulatory considerations and regional differences
Kim Huynh-Ba, Christopher Latoz, and Lori McCaig
4. Kinetics and mechanisms of drug degradation
Christopher M. Riley, Laura Pack, Kimloan Huynh-Ba, Christopher Latoz, and Lori McCaig
5. Analytical procedure life cycle management
Gerald Gellermann, Cristiana Campa, Thomas Pohl, Jean-François Dierick, Petr Obrdlik, Luis Francisco Flores-Ortiz, Katrin Liebelt, Robert Mayer, Adrian Clarke, and Barbara Capecchi
6. Process analytical technology
Ian Clegg
7. Pharmacopeial methods and tests
Eric B. Sheinin
8. Development of United States Pharmacopeia-National Formulary (USPeNF) Monographs and General Chapters
Kim Huynh-Ba and R. Christian Moreton
9. The distinctiveness of the British Pharmacopeia and its relationship to other Pharmacopeia
W John Lough
10. Specifications and analytical procedures in registration applications
Silke Klick
11. Specifications and analytical proceduresin clinical trial applications
Silke Klick
Section III Critical quality attributes
12. Description and identification Ernest Parente
13. Assay and impurities: Specifications of new chemical entities (“small molecules”)
E. Kikovska-Stojanovska, C.M. Riley, A. Clarke, and R.L. Phelps
14. Assay and impurities: Method development as part of analytical life-cycle management
A.M. Clarke and C.M. Riley
15. Assay and impurities: Method validation
C.M. Riley, A. Clarke, and E. Kikovska-Stojanovska
16. Mutagenic impurities
S. Baertschi and B. Olsen
17. Residual solvents
George L. Reid
18. Elemental and inorganic impurities
Ernest Parente
19. Extractables and leachables
James R. Scull, Michael Ruberto, and Kurt L. Moyer
20. Microbiology methods
Dhavalkumar Jain, Santoshi Sharma, Keila Ventura, and Albert Mensah
21. Solid-state methods: An overview
Martin Lindsjö and Thomas Larsson
22. Solid-state characterization e Method development and validation
Patrick A. Tishmack, Ping Chen, and Pamela A. Smith
23. Chiral methods
Brian Lingfeng He
24. Water determination
Mohsen Talebi and Daniel W. Armstrong
Section IV Dosage forms and product types
25. Orally administered dosage forms
Vivian A. Gray, Andreas Abend, and Christopher M. Riley
26. Drug release: Topical products
Kailas Thakker and Ryan Klein
27. Transdermal products
Steven M. Fields
28. Inhalation products
K. Lien Nguyen
29. Ophthalmic products
Huahua Jian, Tao Wang, and Chetan Pujara
30. General analytical considerations for parenteral products
Ema Kikovska-Stojanovska and Sharad Agarwal
31. Specification of biotechnology products including cell and gene therapy
Yin Hwa Lai and Kent L. Amsberry
32. Biotechnology products: Validation of analytical methods
Jennifer E. Dally, Myrna A. Monck, and Kristi R. McKenzie
33. Biosimilars
Cecilia Qvist Michel and Jon Valgeirsson
34. Antibody-drug conjugates
Sharad Agarwal and Ema Kikovska-Stojanovska
35. Oligonucleotides
J Gair Ford, Nadim Akhtar, and Chloe Westley
36. Specifications for vaccines
Cristiana Campa and Julia O’Neill
37. Nanoparticle suspension dosage forms by nanomilling
Robert W. Lee, Laurie Goldman, Todd Wilson, Gillian M. Tocci, and Matthew Irick
38. Development of connected drug delivery systems
Stéphane Baronnet
Section V Biological fluids
39. Bioanalysis of biological matrix samples using liquid chromatography-tandem mass spectrometry detection
Linna Wang, Long Yuan, and Qin C. Ji
40. Bioanalysis of oligonuceotides
Long Yuan
1. Introduction
Christopher M. Riley, K. Lien Nguyen, Gerald Gellerman, and Stephan Kirsch
Section II Regulatory considerations and statistical approaches
2. Principles for setting specifications and shelf lives
Laura Pack, Christopher M. Riley, and Kimloan Huynh-Ba
3. Stability studies: General regulatory considerations and regional differences
Kim Huynh-Ba, Christopher Latoz, and Lori McCaig
4. Kinetics and mechanisms of drug degradation
Christopher M. Riley, Laura Pack, Kimloan Huynh-Ba, Christopher Latoz, and Lori McCaig
5. Analytical procedure life cycle management
Gerald Gellermann, Cristiana Campa, Thomas Pohl, Jean-François Dierick, Petr Obrdlik, Luis Francisco Flores-Ortiz, Katrin Liebelt, Robert Mayer, Adrian Clarke, and Barbara Capecchi
6. Process analytical technology
Ian Clegg
7. Pharmacopeial methods and tests
Eric B. Sheinin
8. Development of United States Pharmacopeia-National Formulary (USPeNF) Monographs and General Chapters
Kim Huynh-Ba and R. Christian Moreton
9. The distinctiveness of the British Pharmacopeia and its relationship to other Pharmacopeia
W John Lough
10. Specifications and analytical procedures in registration applications
Silke Klick
11. Specifications and analytical proceduresin clinical trial applications
Silke Klick
Section III Critical quality attributes
12. Description and identification Ernest Parente
13. Assay and impurities: Specifications of new chemical entities (“small molecules”)
E. Kikovska-Stojanovska, C.M. Riley, A. Clarke, and R.L. Phelps
14. Assay and impurities: Method development as part of analytical life-cycle management
A.M. Clarke and C.M. Riley
15. Assay and impurities: Method validation
C.M. Riley, A. Clarke, and E. Kikovska-Stojanovska
16. Mutagenic impurities
S. Baertschi and B. Olsen
17. Residual solvents
George L. Reid
18. Elemental and inorganic impurities
Ernest Parente
19. Extractables and leachables
James R. Scull, Michael Ruberto, and Kurt L. Moyer
20. Microbiology methods
Dhavalkumar Jain, Santoshi Sharma, Keila Ventura, and Albert Mensah
21. Solid-state methods: An overview
Martin Lindsjö and Thomas Larsson
22. Solid-state characterization e Method development and validation
Patrick A. Tishmack, Ping Chen, and Pamela A. Smith
23. Chiral methods
Brian Lingfeng He
24. Water determination
Mohsen Talebi and Daniel W. Armstrong
Section IV Dosage forms and product types
25. Orally administered dosage forms
Vivian A. Gray, Andreas Abend, and Christopher M. Riley
26. Drug release: Topical products
Kailas Thakker and Ryan Klein
27. Transdermal products
Steven M. Fields
28. Inhalation products
K. Lien Nguyen
29. Ophthalmic products
Huahua Jian, Tao Wang, and Chetan Pujara
30. General analytical considerations for parenteral products
Ema Kikovska-Stojanovska and Sharad Agarwal
31. Specification of biotechnology products including cell and gene therapy
Yin Hwa Lai and Kent L. Amsberry
32. Biotechnology products: Validation of analytical methods
Jennifer E. Dally, Myrna A. Monck, and Kristi R. McKenzie
33. Biosimilars
Cecilia Qvist Michel and Jon Valgeirsson
34. Antibody-drug conjugates
Sharad Agarwal and Ema Kikovska-Stojanovska
35. Oligonucleotides
J Gair Ford, Nadim Akhtar, and Chloe Westley
36. Specifications for vaccines
Cristiana Campa and Julia O’Neill
37. Nanoparticle suspension dosage forms by nanomilling
Robert W. Lee, Laurie Goldman, Todd Wilson, Gillian M. Tocci, and Matthew Irick
38. Development of connected drug delivery systems
Stéphane Baronnet
Section V Biological fluids
39. Bioanalysis of biological matrix samples using liquid chromatography-tandem mass spectrometry detection
Linna Wang, Long Yuan, and Qin C. Ji
40. Bioanalysis of oligonuceotides
Long Yuan
- Edition: 3
- Published: September 25, 2024
- Language: English
CR
Christopher M. Riley
Dr. Christopher Riley is the President of Riley and Rabel Consulting Services. He received a bachelor’s degree in Pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, UK. He taught Pharmaceutical Chemistry, at the Universities of Florida (1983-6) and the University of Kansas (1986-94), and was a Vice President at DuPont Merck (1994-2001) and ALZA (a division of J&J) (2001-7). He has coauthored more than 140 book chapters and papers in peer-reviewed journals, as well as 5 books. He has extensive experience in CMC regulatory affairs and the development of all types of dosage forms.
Affiliations and expertise
President of Riley and Rabel Consulting Services, Maryville, MO, USAKN
K. Lien Nguyen
Dr. Nguyen is Head of Chemistry, Manufacturing and Controls at IRL AB in Sweden. She received a Bachelor of Chemical Engineering from University of Adelaide, Australia (2003) and Ph.D. in Chemical Engineering from University of Cambridge, UK (2007). She worked at GlaxoSmithKline (UK), AstraZeneca (Sweden) and Savara Pharmaceuticals (Denmark) in various roles across pharmaceutical development. She has extensive experience in the development of all types of dosage forms in general, and inhalation products in particular.
Affiliations and expertise
Head of Chemistry, Manufacturing and Controls at IRL AB, SwedenRead Specification of Drug Substances and Products on ScienceDirect