Specification of Drug Substances and Products
Development and Validation of Analytical Methods
- 3rd Edition - July 1, 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
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Request a sales quoteSpecification 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), and specification setting (Q6), as well as the latest guideline on Analytical Method Development (Q14)
- 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 to forms to, natural products, vaccines, and gene therapy.
- Presents detailed treatment of latest statistical approaches (including new approaches to the treatment of validation data method, specification setting, and shelf-life prediction)
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 1: INTRODUCTION
1 Introduction
CM Riley and L Nguyen
SECTION 2: REGULATORY CONSIDERATIONS AND STATISTICAL APPROACHES
2 General Principles and Regulatory Considerations: Specifications and Shelf-Life Setting
CM Riley and H Yang
3 Specifications and Expiry Dates based on Accelerated Stability Studies
CM Riley and K Huynh-Ba
4 Analytical Procedure Life Cycle Management
Gellerman, C Campa, AM Clark and CM Riley
5 Analytical Target Profiles for Quality Attributes
K Lieblt, AM Clark and CM Riley
6 Process Analytical Technology
L Nguyen
7 Pharmacopeial Methods and Tests ER
Sheinin
8 USP Monographs
Kim Huynh-Ba
9 British Pharmacopoeia
L Elanganathan and J Lough
10 Submission, Review and Approval of Specifications and Analytical Procedures: Pre-Clinical and Clinical Phases
S Klick
11 Submission, Review and Approval of Specifications and Analytical Procedures: Marketing Authorization Applications
S Klick
12 Special Regional Requirements: ASEAN, ANVISA and WHO
K Huynh-Ba
SECTION 3: Critical Quality Attributes
13 Description and Identification
E Parente
14 Assay and Impurities: Specifications
E Kikovska-Stojanovskaa, CM Riley, AM Clarke and RL Phelps
15 Assay and Impurities: Method Development as Part of Analytical Life Cycle Management
AM Clarke and CM Riley
16 Assay and Impurities: Validation
CM Riley, AM Clarke, and E Kikovska-Stojanovska
17 Mutagenic Impurities
S Baertschi and B Olsen
18 Residual Solvents
GL Reid
19 Elemental and Inorganic Impurities
E Parente
20 Extractables and Leachables
KL Moyer, JR Scull and M Roberto
21 Microbiological Testing
A Mensah and N Contompasis
22 Solid-State Characterization
PA Tishmack, P Chen and PA Smith
23 Chiral Methods
BL He and DK Lloyd
24 Water Determination
M Talebi and DW Armstrong
SECTION 4: DOSAGE FORMS AND PRODUCT TYPES
25 Orally Administered Dosage Forms
CM Riley and VA Gray
26 Topical Products
K Thakker and R Klein
27 Transdermal Products
S Fields
28 Inhalation Products and Nasal Sprays
L Nguyen
29 Ophthalmic Products
H Jian and C Pujara
30 General Parenteral Products
M Quayle
31 Specification of Biotechnology Products
YH Lai and KL Amsberry
32 Biotechnology Products
JE Daily and MA Monck
33 Antibodies and Antibody-Drug Conjugates
E Kikovska-Stojanovska
34 Oligonucleotides and m-RNA and DNA Delivery Systems
Silke Klick
35 Liposomes
A Elkordy
36 Vaccines
C Campa and J O’Neill
37 Gene Therapy
R Wu
38 Nanoparticles
R Lee and Judy Cohen
39 Digital Drug Delivery Systems
S Baronnet
40 Natural Products
Gjose Stefkov
Section 5: Biological Fluids
41 Bioanalysis of Biological Matrix Samples using Liquid Chromatography
L Wang, L Yuan and QC ji
1 Introduction
CM Riley and L Nguyen
SECTION 2: REGULATORY CONSIDERATIONS AND STATISTICAL APPROACHES
2 General Principles and Regulatory Considerations: Specifications and Shelf-Life Setting
CM Riley and H Yang
3 Specifications and Expiry Dates based on Accelerated Stability Studies
CM Riley and K Huynh-Ba
4 Analytical Procedure Life Cycle Management
Gellerman, C Campa, AM Clark and CM Riley
5 Analytical Target Profiles for Quality Attributes
K Lieblt, AM Clark and CM Riley
6 Process Analytical Technology
L Nguyen
7 Pharmacopeial Methods and Tests ER
Sheinin
8 USP Monographs
Kim Huynh-Ba
9 British Pharmacopoeia
L Elanganathan and J Lough
10 Submission, Review and Approval of Specifications and Analytical Procedures: Pre-Clinical and Clinical Phases
S Klick
11 Submission, Review and Approval of Specifications and Analytical Procedures: Marketing Authorization Applications
S Klick
12 Special Regional Requirements: ASEAN, ANVISA and WHO
K Huynh-Ba
SECTION 3: Critical Quality Attributes
13 Description and Identification
E Parente
14 Assay and Impurities: Specifications
E Kikovska-Stojanovskaa, CM Riley, AM Clarke and RL Phelps
15 Assay and Impurities: Method Development as Part of Analytical Life Cycle Management
AM Clarke and CM Riley
16 Assay and Impurities: Validation
CM Riley, AM Clarke, and E Kikovska-Stojanovska
17 Mutagenic Impurities
S Baertschi and B Olsen
18 Residual Solvents
GL Reid
19 Elemental and Inorganic Impurities
E Parente
20 Extractables and Leachables
KL Moyer, JR Scull and M Roberto
21 Microbiological Testing
A Mensah and N Contompasis
22 Solid-State Characterization
PA Tishmack, P Chen and PA Smith
23 Chiral Methods
BL He and DK Lloyd
24 Water Determination
M Talebi and DW Armstrong
SECTION 4: DOSAGE FORMS AND PRODUCT TYPES
25 Orally Administered Dosage Forms
CM Riley and VA Gray
26 Topical Products
K Thakker and R Klein
27 Transdermal Products
S Fields
28 Inhalation Products and Nasal Sprays
L Nguyen
29 Ophthalmic Products
H Jian and C Pujara
30 General Parenteral Products
M Quayle
31 Specification of Biotechnology Products
YH Lai and KL Amsberry
32 Biotechnology Products
JE Daily and MA Monck
33 Antibodies and Antibody-Drug Conjugates
E Kikovska-Stojanovska
34 Oligonucleotides and m-RNA and DNA Delivery Systems
Silke Klick
35 Liposomes
A Elkordy
36 Vaccines
C Campa and J O’Neill
37 Gene Therapy
R Wu
38 Nanoparticles
R Lee and Judy Cohen
39 Digital Drug Delivery Systems
S Baronnet
40 Natural Products
Gjose Stefkov
Section 5: Biological Fluids
41 Bioanalysis of Biological Matrix Samples using Liquid Chromatography
L Wang, L Yuan and QC ji
- No. of pages: 1190
- Language: English
- Edition: 3
- Published: July 1, 2024
- Imprint: Elsevier
- Paperback ISBN: 9780443134661
CR
Christopher M. Riley
Dr Riley is President, Riley and Rabel Consulting Services, Inc. He received a bachelor’s degree in pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, England. He was a post-doctoral fellow at the University of Kansas in the Department of Pharmaceutical Chemistry (1981-1982) before joining the faculty of the Department of Pharmaceutics at the University of Florida. He returned to the University of Kansas as faculty member in 1986 where he remained until 1994. He was Vice President and Head of Analytical R&D at Dupont Pharmaceuticals (previously Dupont Merck) from 1994 to 2001. He joined ALZA 2001, a subsidiary of Johnson & Johnson, where he had positions of increasing responsibility up to Vice President and West Coast Site Head ChemPharm Development. He left ALZA in May 2007 to form Riley and Rabel Consulting Services, Inc., which provides consulting services to the Pharmaceutical and Biotechnology Industries, specializing in Analytical and Pharmaceutical Development, CMC Strategy, Organizational and Managerial Effectiveness and Patent Litigation. He has co-authored more than 140 book chapters and papers in peer-reviewed journals, as well as five books. He was awarded the Conference Science Award of the Royal Pharmaceutical Society of Great Britain and the Jubilee Medal of the Chromatographic Society. He was elected Fellow of the American Association of Pharmaceutical Scientists (AAPS) and served as the chair of the Analysis and Pharmaceutical Quality Section of AAPS and a Member of the AAPS Executive Committee. Dr. Riley has served as member and chair of the PhRMA Analytical Technical Committee (ATC), as well as a member and chair of the PhRMA Technical Leadership Committee (TLC). Dr. Riley represented PhRMA on the ICH Expert Working Group on Impurities in Drug Substances (Q3A) and Drug Products (Q3B) and was Chair of the PhRMA Working Group on Genotoxic Impurities.
Affiliations and expertise
President of Riley and Rabel Consulting Services, Maryville, MO, USAKN
K. Lien Nguyen
Dr. Nguyen is Head of Chemistry, Manufacturing and Control and 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 Control and IRL AB, Sweden