Kenneth L. Hastings – författare
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9 produkter
9 produkter
Inbunden, Engelska, 2013
1 732 kr
Skickas inom 5-8 vardagar
Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human UseNational regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and AustraliaRepeated dose toxicity studiesCarcinogenicity; Genotoxicity; Developmental and reproductive toxicology; ImmunotoxicologyBiotechnology-derived pharmaceuticalsVaccine developmentPhototoxicity and photocarcinogenicityDegradants, impurities, excipients and metabolitesPrimarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.
Inbunden, Engelska, 2025
3 406 kr
Skickas inom 10-15 vardagar
The second edition of The Minipig in Biomedical Research is a comprehensive resource for research scientists on the use of the minipig in basic and applied biomedical research. Written by experts in the field, coverage extends from the minipig’s origins, anatomy, genetics, immunology, pathology and physiology to its welfare, health, and husbandry; practical dosing and examination procedures; surgical techniques; and all areas of toxicity testing and the uses of the minipig as a disease model. The book represents the state of the art, recognising the growing influence of Artificial Intelligence, and where appropriate, relevant databases are referenced. The future of minipigs with respect to genome editing and possible use in transplantation research makes this a very interesting model.Since the first edition was published there has been a considerable increase in scientific, industrial and regulatory interest in the minipig; in some jurisdictions, for instance the UK, it is mandated that the minipig should be considered as a first-line non-rodent model. The expert authors in this new edition have given practical details and extensive examples of its successful application in many fields including surgery, drug development and safety testing. Greater emphasis is given to the origins and uses of several different strains of minipig, the greater understanding of genomics, genetic manipulation, immunology, their value in the development of novel exploratory and therapeutic implantable devices, and genetic and surgical procedures.The second edition includes full color throughout, with high-quality illustrations, making it the go-to guide and resource for present and potential new users of minipigs.
E-bok
Engelska, 20113 463 kr
Läs direkt efter köp
The Minipig in Biomedical Research is a comprehensive resource for research scientists on the potential and use of the minipig in basic and applied biomedical research, and the development of drugs and chemicals. Written by acknowledged experts in the field, and drawing on the authors'' global contacts and experience with regulatory authorities and
E-bok
PDF, Engelska, 20253 722 kr
Läs direkt efter köp
The second edition of The Minipig in Biomedical Research is a comprehensive resource for research scientists on the use of the minipig in basic and applied biomedical research. Written by experts in the field, coverage extends from the minipig's origins, anatomy, genetics, immunology, pathology and physiology to its welfare, health, and husbandry; practical dosing and examination procedures; surgical techniques; and all areas of toxicity testing and the uses of the minipig as a disease model. The book represents the state of the art, recognising the growing influence of Artificial Intelligence, and where appropriate, relevant databases are referenced. The future of minipigs with respect to genome editing and possible use in transplantation research makes this a very interesting model.Since the first edition was published there has been a considerable increase in scientific, industrial and regulatory interest in the minipig; in some jurisdictions, for instance the UK, it is mandated that the minipig should be considered as a first-line non-rodent model. The expert authors in this new edition have given practical details and extensive examples of its successful application in many fields including surgery, drug development and safety testing. Greater emphasis is given to the origins and uses of several different strains of minipig, the greater understanding of genomics, genetic manipulation, immunology, their value in the development of novel exploratory and therapeutic implantable devices, and genetic and surgical procedures.The second edition includes full color throughout, with high-quality illustrations, making it the go-to guide and resource for present and potential new users of minipigs.
E-bok
Engelska, 20253 722 kr
Läs direkt efter köp
The second edition of The Minipig in Biomedical Research is a comprehensive resource for research scientists on the use of the minipig in basic and applied biomedical research. Written by experts in the field, coverage extends from the minipig's origins, anatomy, genetics, immunology, pathology and physiology to its welfare, health, and husbandry; practical dosing and examination procedures; surgical techniques; and all areas of toxicity testing and the uses of the minipig as a disease model. The book represents the state of the art, recognising the growing influence of Artificial Intelligence, and where appropriate, relevant databases are referenced. The future of minipigs with respect to genome editing and possible use in transplantation research makes this a very interesting model.Since the first edition was published there has been a considerable increase in scientific, industrial and regulatory interest in the minipig; in some jurisdictions, for instance the UK, it is mandated that the minipig should be considered as a first-line non-rodent model. The expert authors in this new edition have given practical details and extensive examples of its successful application in many fields including surgery, drug development and safety testing. Greater emphasis is given to the origins and uses of several different strains of minipig, the greater understanding of genomics, genetic manipulation, immunology, their value in the development of novel exploratory and therapeutic implantable devices, and genetic and surgical procedures.The second edition includes full color throughout, with high-quality illustrations, making it the go-to guide and resource for present and potential new users of minipigs.
2 023 kr
Läs direkt efter köp
Nonclinical Safety Assessment
Nonclinical Safety Assessment
A Guide to International Pharmaceutical Regulations
Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions.
It includes:
ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolitesPrimarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.
E-bok
PDF, Engelska, 20132 023 kr
Läs direkt efter köp
Nonclinical Safety Assessment
Nonclinical Safety Assessment
A Guide to International Pharmaceutical Regulations
Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions.
It includes:
ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolitesPrimarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.
E-bok
PDF, Engelska, 20113 463 kr
Läs direkt efter köp
The Minipig in Biomedical Research is a comprehensive resource for research scientists on the potential and use of the minipig in basic and applied biomedical research, and the development of drugs and chemicals. Written by acknowledged experts in the field, and drawing on the authors'' global contacts and experience with regulatory authorities and
Inbunden, Engelska, 2011
2 046 kr
Tillfälligt slut
The Minipig in Biomedical Research is a comprehensive resource for research scientists on the potential and use of the minipig in basic and applied biomedical research, and the development of drugs and chemicals. Written by acknowledged experts in the field, and drawing on the authors’ global contacts and experience with regulatory authorities and the pharmaceutical and other industries, this accessible manual ranges widely over the biological, scientific, and practical uses of the minipig in the laboratory. Its coverage extends from the minipig’s origins, anatomy, genetics, immunology, and physiology to its welfare, health, and husbandry; practical dosing and examination procedures; surgical techniques; and all areas of toxicity testing and the uses of the minipig as a disease model. Regulatory aspects of its use are considered.The reader will find an extensive amount of theoretical and practical information in the pharmacology; ADME and toxicology chapters which will help scientists and managers when deciding which species to use in basic research; drug discovery and pharmacology; and toxicology studies of chemicals, biotechnology products and devices. The book discusses regulatory uses of minipigs in the evaluation of human and veterinary pharmaceuticals, medical devices, and other classes of xenobiotics. It describes features of normal health, normal laboratory values, and common diseases. It also carefully elucidates ethical and legal considerations in their supply, housing, and transport. The result is an all-inclusive and up to date manual about the experimental uses of the minipig that describes ‘How to’ and ‘Why’ and ’What to expect in the normal’, combining enthusiasm and experience with critical assessment of its values and potential problems.