Current Topics in Nonclinical Drug Development: Volume 1: Current Topics in Nonclinical Drug Development Series
Editat de Pritam S. Sahota, Philip Bentley, Zbigniew Wojcinskien Limba Engleză Hardback – 23 dec 2020
Additional features include:
- Deals with day-to-day issues in study design, evaluation of findings, and presentation of data.
- Explains new approaches in the development of medical devices.
- Includes dedicated chapters on the use of bioinformatics in drug development.
- Addresses strategies for photosafety testing of drugs.
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Specificații
ISBN-13: 9780367136277
ISBN-10: 0367136279
Pagini: 336
Ilustrații: 10 Line drawings, black and white; 11 Halftones, black and white; 24 Tables, black and white; 5 Illustrations, color; 16 Illustrations, black and white
Dimensiuni: 156 x 234 x 23 mm
Greutate: 0.7 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
Seria Current Topics in Nonclinical Drug Development Series
ISBN-10: 0367136279
Pagini: 336
Ilustrații: 10 Line drawings, black and white; 11 Halftones, black and white; 24 Tables, black and white; 5 Illustrations, color; 16 Illustrations, black and white
Dimensiuni: 156 x 234 x 23 mm
Greutate: 0.7 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
Seria Current Topics in Nonclinical Drug Development Series
Public țintă
Professional ReferenceCuprins
Contents
PREFACE VII
ACKNOWLEDGMENTS IX
EDITORS XI
CONTRIBUTORS XV
1 Bioinformatics/Impact of Computational Biology
for Molecular Safety Assessment during Drug
Development 1
JULIANE PERNER, MEGUMI ONISHI-SEEBACHER,
ALBERTO DEL RIO ESPINOLA, ELAINE TRITTO, PHILIPPE COUTTET,
RÉMI TERRANOVA, AND JONATHAN MOGGS
2 Integrating Toxicogenomics Data into Risk
Assessment 23
ARUN R. PANDIRI, WARREN CASEY, AND SCOTT S. AUERBACH
3 New Approaches in Development
of Medical Devices 53
SHANNON M. WALLACE, PEGGY A. LALOR,
AND KATHLEEN A. FUNK
4 Recent Advances in the Development
of Novel Biomarkers of Toxicity 81
DOMINIQUE BREES, DANA WALKER, DAVID LEDIEU,
DAVID BROTT MICHAEL MERZ, AND JACQUELINE TARRANT
5 Preclinical Evaluation and Translational
Development of Cell and Gene Therapies 121
SHON GREEN, TIMOTHY K. MACLACHLAN, JENNIFER L.
MARLOWE, AND PRASHANT NAMBIAR
6 Value of Juvenile Toxicity Studies 185
PAUL BALDRICK
7 Photosafety Testing of Drugs 223
ANTHONY M. LYNCH AND DANIEL BAUER
8 Combination Safety Assessment During Drug
Development 275
JOANNE BIRKEBAK, SHERRY L. RALSTON,
AND LEIGH ANN BURNS-NAAS
INDEX 307
PREFACE VII
ACKNOWLEDGMENTS IX
EDITORS XI
CONTRIBUTORS XV
1 Bioinformatics/Impact of Computational Biology
for Molecular Safety Assessment during Drug
Development 1
JULIANE PERNER, MEGUMI ONISHI-SEEBACHER,
ALBERTO DEL RIO ESPINOLA, ELAINE TRITTO, PHILIPPE COUTTET,
RÉMI TERRANOVA, AND JONATHAN MOGGS
2 Integrating Toxicogenomics Data into Risk
Assessment 23
ARUN R. PANDIRI, WARREN CASEY, AND SCOTT S. AUERBACH
3 New Approaches in Development
of Medical Devices 53
SHANNON M. WALLACE, PEGGY A. LALOR,
AND KATHLEEN A. FUNK
4 Recent Advances in the Development
of Novel Biomarkers of Toxicity 81
DOMINIQUE BREES, DANA WALKER, DAVID LEDIEU,
DAVID BROTT MICHAEL MERZ, AND JACQUELINE TARRANT
5 Preclinical Evaluation and Translational
Development of Cell and Gene Therapies 121
SHON GREEN, TIMOTHY K. MACLACHLAN, JENNIFER L.
MARLOWE, AND PRASHANT NAMBIAR
6 Value of Juvenile Toxicity Studies 185
PAUL BALDRICK
7 Photosafety Testing of Drugs 223
ANTHONY M. LYNCH AND DANIEL BAUER
8 Combination Safety Assessment During Drug
Development 275
JOANNE BIRKEBAK, SHERRY L. RALSTON,
AND LEIGH ANN BURNS-NAAS
INDEX 307
Notă biografică
Pritam S. Sahota, Global ToxPath LLC, Kennewick, Washington, USA,
has extensive experience in toxicologic pathology and drug development
within the framework of nonclinical safety assessment of pharmaceuticals.
Dr. Sahota was previously Executive Director and Head of Pathology,
Preclinical Safety, at Novartis Pharmaceuticals, East Hanover, New Jersey.
He obtained his veterinary medicine (BVSc) and veterinary pathology
degrees (MSc and PhD) from Punjab Agricultural University, India. He
is a diplomate of the American Board of Toxicology. After receiving his
PhD in 1976, he started working as a toxicologic pathologist at Dawson
Research Corporation (DRC), Orlando, Florida, a contract research organization
involved in the preclinical safety evaluation of drugs and chemicals.
At DRC, he received increasing responsibility over the next 10 years
(toxicologic pathologist, senior toxicologic pathologist, and scientific director).
As a scientific director, he was responsible for the scientific aspects of
pathology as well as toxicology at DRC. While working briefly for Dynamac
Corporation, Research Triangle Park, North Carolina (1986–1987), he conducted
retrospective scientific audits of 23 NTP carcinogenicity studies and
participated in discussions with the representatives of NTP, FDA, and EPA
to review the results of scientific audits of over 200 NTP carcinogenicity
studies. In 1987, he joined Ciba-Geigy Pharmaceuticals in New Jersey as
Head/Manager of pathologists in preclinical safety and was also responsible
for establishing pathology peer review, quality control, and scheduling
systems. He continued to work primarily in this position with increasing
responsibilities at Ciba-Geigy and then Novartis Pharmaceuticals (after
Ciba-Sandoz merger in 1997) to become director and eventually Executive
Director and Head of pathology. During this time, he also served as an international
project team representative for a number of successfully marketed
CNS, immunosuppression, diabetes, and cardiovascular drugs, including
Diovan, which eventually became one of the 15 all-time, best-selling prescription
drugs. He also held an adjunct academic appointment of Assistant
Professor at the University of Medicine and Dentistry, New Jersey, for
8 years. He successfully led several global preclinical safety initiatives at
Novartis, including patient centricity, review of best practices in cardiotoxicity
and ocular toxicity, as well as evaluation of rodent carcinogenicity
potential based on noncarcinogenicity data to minimize future delays in
regulatory submissions. Since retirement from Novartis Pharmaceuticals
in 2012, Dr Sahota has been the President of Global ToxPath LLC located
in Kennewick, WA, USA (Toxicologic Pathology Consultancy). As lead editor,
he published the following books with CRC Press/Taylor & Francis:
(1) Toxicologic Pathology: Nonclinical Safety Assessment (First Edition,
2013); (2) Toxicologic Pathology: Nonclinical Safety Assessment (Second
Edition, 2018); (3) The Illustrated Dictionary of Toxicologic Pathology and
Safety Science (First Edition, 2019); (4) CT-NCDD: Volume 1 (due to be
published in 2020); (5) Road to Greatness (due to be published in 2020);
(6) Toxicologic Pathology: A Primer (due to be published in 2021); and
(7) Toxicologic Pathology: An Atlas (due to be published in 2022).
Philip Bentley is a principal consultant at Toxicodynamix International
LLC. He studied biochemistry at the University of Hull, UK, graduating
with a BSc in 1970 and a PhD in 1974. He had postdoctoral fellowships at
the Universities of Basel, Switzerland, and Mainz, Germany. His postdoctoral
research centered upon formation and inactivation of reactive metabolites
and the enzymes involved in the metabolism of foreign compounds. In
1979, he joined the Investigative Toxicology group (known as Cell Biology)
in the Toxicology Department of Ciba-Geigy, Basel, Switzerland, and
remained with the company, later Novartis, until 2014. In these 35 years,
he held various management positions in Europe and the United States
with responsibility for Investigative Toxicology; Drug Metabolism; Drug
Metabolism and Toxicology; Preclinical Safety Europe; Drug Metabolism
and Pharmacokinetics; Toxicology/Pathology United States; Preclinical
Safety United States; and Global Preclinical Safety. In these positions, he
contributed to the registration of more than 45 marketed drug products and
the preparation of several hundred investigational new drugs (INDs). He
has vast experience in the areas of drug metabolism and disposition, toxicology/
pathology, genetic toxicology, pharmacokinetics/toxicokinetics,
and all aspects of investigative toxicology. He is well grounded in biochemistry,
cell biology, molecular biology, and pharmacology with the ability to
integrate data from the different preclinical disciplines to enable translation
to determine the clinical relevance of the findings. He is very familiar with
global drug registration requirements and working on global projects.
He has authored more than 80 scientific publications, has lectured
in toxicology at the University of Basel for more than 30 years, and is a
past president of the European Society of Biochemical Pharmacology
and the Swiss Society of Toxicology. He was a member of the PhRMA/IQ
Preclinical Leadership (DruSafe) Committee for 16 years, a member of the
advisory board of the PSTC Biomarker consortium, and a member of the
expert working group for revision of the ICH S2 guidance on genotoxicity
testing and the PhRMA expert group on genotoxic impurities.
Zbigniew W. Wojcinski is president of Toxicology & Pathology Consulting,
LLC, in Ann Arbor, Michigan, and has over 30 years of experience in drug
development. Dr. Wojcinski received his undergraduate degree (BSc) in
Zoology from the University of Toronto and his DVM and DVSc (Pathology)
degrees from the Ontario Veterinary College, University of Guelph. He is a
board-certified diplomate of the American Board of Toxicology and a diplomate
of the American College of Veterinary Pathologists. He is also recognized
as a specialist in Veterinary Pathology by the Canadian Veterinary
Medical Association. Dr Wojcinski gained experience in drug development
and toxicologic pathology during his 22-year tenure with Parke-Davis\
Warner-Lambert and Pfizer Global Research and Development and then 31/2
years with Fulcrum Pharma Developments, Inc. In 2011, he founded Drug
Development Pathology Services, LLC in Ann Arbor, Michigan, and subsequently
grew the organization into Drug Development Preclinical Services,
LLC to provide toxicology, pathology, and drug metabolism and pharmacokinetic
services. Dr Wojcinski has extensive experience as a study director,
study pathologist, and review pathologist for numerous acute and repeated
dose toxicity studies, including carcinogenicity studies. Throughout his
career, he has managed successful cross-functional drug development
teams in CNS, metabolic diseases, and dermatology therapeutic areas. As
therapeutic area leader for Dermatology at Pfizer, Dr Wojcinski was responsible
for development and implementation of the safety and risk management
strategies for, what was then, a new therapeutic area. He has also
been directly involved in the preparation of pre-IND documents, nonclinical
safety assessments for IND/IMPD/NDA/MAA, investigator’s brochures,
and labeling (USPI, SmPC) negotiations in CNS, anti-infective, and dermatology
therapeutic areas. Dr Wojcinski has had numerous interactions with
regulatory agencies in the United States, Europe, Canada, and Australia for
compounds at various stages of development. He has also provided pathology
consultation and histopathology peer review on several projects in various
therapeutic areas, including respiratory infections, dermatitis, ophthalmic
disease, anticancer, and hypolipidemics, and served on Pathology Working
Groups. Dr Wojcinski is a full member of numerous professional societies
including the American College of Veterinary Pathologists, Society
of Toxicologic Pathologists, Society of Toxicology, American College of
Toxicology, American Veterinary Medical Association, Canadian Veterinary
Medical Association, Canadian Association of Veterinary Pathologists,
Regulatory Affairs Professionals Society, and Roundtable of Toxicology
Consultants. He has served as president of the Dermal Toxicity Specialty
Section of the Society of Toxicology, an associate editor for the Society of
Toxicologic Pathology, editor of The Scope for the Society of Toxicologic
Pathology, and chair of the Society of Toxicologic Pathology Recruitment
Subcommittee. Dr Wojcinski has lectured at the Ontario Veterinary College
and the University of Maryland and authored/coauthored numerous scientific
reports, manuscripts, and book chapters. Recently, he was coeditor
for The Illustrated Dictionary of Toxicologic Pathology & Safety Science (First
Edition, published in 2019) and is currently contributing editor for Road to
Greatness (due to be published in 2020); coeditor for Toxicologic Pathology:
A Primer (due to be published in 2021); and coeditor for Toxicologic Pathology:
An Atlas (due to be published in 2022).
has extensive experience in toxicologic pathology and drug development
within the framework of nonclinical safety assessment of pharmaceuticals.
Dr. Sahota was previously Executive Director and Head of Pathology,
Preclinical Safety, at Novartis Pharmaceuticals, East Hanover, New Jersey.
He obtained his veterinary medicine (BVSc) and veterinary pathology
degrees (MSc and PhD) from Punjab Agricultural University, India. He
is a diplomate of the American Board of Toxicology. After receiving his
PhD in 1976, he started working as a toxicologic pathologist at Dawson
Research Corporation (DRC), Orlando, Florida, a contract research organization
involved in the preclinical safety evaluation of drugs and chemicals.
At DRC, he received increasing responsibility over the next 10 years
(toxicologic pathologist, senior toxicologic pathologist, and scientific director).
As a scientific director, he was responsible for the scientific aspects of
pathology as well as toxicology at DRC. While working briefly for Dynamac
Corporation, Research Triangle Park, North Carolina (1986–1987), he conducted
retrospective scientific audits of 23 NTP carcinogenicity studies and
participated in discussions with the representatives of NTP, FDA, and EPA
to review the results of scientific audits of over 200 NTP carcinogenicity
studies. In 1987, he joined Ciba-Geigy Pharmaceuticals in New Jersey as
Head/Manager of pathologists in preclinical safety and was also responsible
for establishing pathology peer review, quality control, and scheduling
systems. He continued to work primarily in this position with increasing
responsibilities at Ciba-Geigy and then Novartis Pharmaceuticals (after
Ciba-Sandoz merger in 1997) to become director and eventually Executive
Director and Head of pathology. During this time, he also served as an international
project team representative for a number of successfully marketed
CNS, immunosuppression, diabetes, and cardiovascular drugs, including
Diovan, which eventually became one of the 15 all-time, best-selling prescription
drugs. He also held an adjunct academic appointment of Assistant
Professor at the University of Medicine and Dentistry, New Jersey, for
8 years. He successfully led several global preclinical safety initiatives at
Novartis, including patient centricity, review of best practices in cardiotoxicity
and ocular toxicity, as well as evaluation of rodent carcinogenicity
potential based on noncarcinogenicity data to minimize future delays in
regulatory submissions. Since retirement from Novartis Pharmaceuticals
in 2012, Dr Sahota has been the President of Global ToxPath LLC located
in Kennewick, WA, USA (Toxicologic Pathology Consultancy). As lead editor,
he published the following books with CRC Press/Taylor & Francis:
(1) Toxicologic Pathology: Nonclinical Safety Assessment (First Edition,
2013); (2) Toxicologic Pathology: Nonclinical Safety Assessment (Second
Edition, 2018); (3) The Illustrated Dictionary of Toxicologic Pathology and
Safety Science (First Edition, 2019); (4) CT-NCDD: Volume 1 (due to be
published in 2020); (5) Road to Greatness (due to be published in 2020);
(6) Toxicologic Pathology: A Primer (due to be published in 2021); and
(7) Toxicologic Pathology: An Atlas (due to be published in 2022).
Philip Bentley is a principal consultant at Toxicodynamix International
LLC. He studied biochemistry at the University of Hull, UK, graduating
with a BSc in 1970 and a PhD in 1974. He had postdoctoral fellowships at
the Universities of Basel, Switzerland, and Mainz, Germany. His postdoctoral
research centered upon formation and inactivation of reactive metabolites
and the enzymes involved in the metabolism of foreign compounds. In
1979, he joined the Investigative Toxicology group (known as Cell Biology)
in the Toxicology Department of Ciba-Geigy, Basel, Switzerland, and
remained with the company, later Novartis, until 2014. In these 35 years,
he held various management positions in Europe and the United States
with responsibility for Investigative Toxicology; Drug Metabolism; Drug
Metabolism and Toxicology; Preclinical Safety Europe; Drug Metabolism
and Pharmacokinetics; Toxicology/Pathology United States; Preclinical
Safety United States; and Global Preclinical Safety. In these positions, he
contributed to the registration of more than 45 marketed drug products and
the preparation of several hundred investigational new drugs (INDs). He
has vast experience in the areas of drug metabolism and disposition, toxicology/
pathology, genetic toxicology, pharmacokinetics/toxicokinetics,
and all aspects of investigative toxicology. He is well grounded in biochemistry,
cell biology, molecular biology, and pharmacology with the ability to
integrate data from the different preclinical disciplines to enable translation
to determine the clinical relevance of the findings. He is very familiar with
global drug registration requirements and working on global projects.
He has authored more than 80 scientific publications, has lectured
in toxicology at the University of Basel for more than 30 years, and is a
past president of the European Society of Biochemical Pharmacology
and the Swiss Society of Toxicology. He was a member of the PhRMA/IQ
Preclinical Leadership (DruSafe) Committee for 16 years, a member of the
advisory board of the PSTC Biomarker consortium, and a member of the
expert working group for revision of the ICH S2 guidance on genotoxicity
testing and the PhRMA expert group on genotoxic impurities.
Zbigniew W. Wojcinski is president of Toxicology & Pathology Consulting,
LLC, in Ann Arbor, Michigan, and has over 30 years of experience in drug
development. Dr. Wojcinski received his undergraduate degree (BSc) in
Zoology from the University of Toronto and his DVM and DVSc (Pathology)
degrees from the Ontario Veterinary College, University of Guelph. He is a
board-certified diplomate of the American Board of Toxicology and a diplomate
of the American College of Veterinary Pathologists. He is also recognized
as a specialist in Veterinary Pathology by the Canadian Veterinary
Medical Association. Dr Wojcinski gained experience in drug development
and toxicologic pathology during his 22-year tenure with Parke-Davis\
Warner-Lambert and Pfizer Global Research and Development and then 31/2
years with Fulcrum Pharma Developments, Inc. In 2011, he founded Drug
Development Pathology Services, LLC in Ann Arbor, Michigan, and subsequently
grew the organization into Drug Development Preclinical Services,
LLC to provide toxicology, pathology, and drug metabolism and pharmacokinetic
services. Dr Wojcinski has extensive experience as a study director,
study pathologist, and review pathologist for numerous acute and repeated
dose toxicity studies, including carcinogenicity studies. Throughout his
career, he has managed successful cross-functional drug development
teams in CNS, metabolic diseases, and dermatology therapeutic areas. As
therapeutic area leader for Dermatology at Pfizer, Dr Wojcinski was responsible
for development and implementation of the safety and risk management
strategies for, what was then, a new therapeutic area. He has also
been directly involved in the preparation of pre-IND documents, nonclinical
safety assessments for IND/IMPD/NDA/MAA, investigator’s brochures,
and labeling (USPI, SmPC) negotiations in CNS, anti-infective, and dermatology
therapeutic areas. Dr Wojcinski has had numerous interactions with
regulatory agencies in the United States, Europe, Canada, and Australia for
compounds at various stages of development. He has also provided pathology
consultation and histopathology peer review on several projects in various
therapeutic areas, including respiratory infections, dermatitis, ophthalmic
disease, anticancer, and hypolipidemics, and served on Pathology Working
Groups. Dr Wojcinski is a full member of numerous professional societies
including the American College of Veterinary Pathologists, Society
of Toxicologic Pathologists, Society of Toxicology, American College of
Toxicology, American Veterinary Medical Association, Canadian Veterinary
Medical Association, Canadian Association of Veterinary Pathologists,
Regulatory Affairs Professionals Society, and Roundtable of Toxicology
Consultants. He has served as president of the Dermal Toxicity Specialty
Section of the Society of Toxicology, an associate editor for the Society of
Toxicologic Pathology, editor of The Scope for the Society of Toxicologic
Pathology, and chair of the Society of Toxicologic Pathology Recruitment
Subcommittee. Dr Wojcinski has lectured at the Ontario Veterinary College
and the University of Maryland and authored/coauthored numerous scientific
reports, manuscripts, and book chapters. Recently, he was coeditor
for The Illustrated Dictionary of Toxicologic Pathology & Safety Science (First
Edition, published in 2019) and is currently contributing editor for Road to
Greatness (due to be published in 2020); coeditor for Toxicologic Pathology:
A Primer (due to be published in 2021); and coeditor for Toxicologic Pathology:
An Atlas (due to be published in 2022).
Descriere
The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. The book will aid toxicologists, toxicologic pathologists, regulators, and study directors, dealing with issues in study design, evaluation of findings, and presentation of data.