| Description |
1 online resource (567 p.) |
| Contents |
Cover -- Half Title -- Title Page -- Copyright Page -- Dedication -- Table of Contents -- Foreword -- Preface -- About the Authors -- Part I Introductory Chapters -- 1 Drug Discovery -- 1.1 Introduction -- 1.1.1 Elements of Drug Discovery -- 1.1.1.1 Sources of Drugs -- 1.1.1.2 Genetic Engineering -- 1.1.1.3 Gene Therapy -- 1.2 Collaborating Disciplines -- 1.2.1 Biology -- 1.2.2 Chemistry -- 1.2.3 Pharmaceutics -- 1.2.4 Animal Toxicology -- 1.2.5 Clinical Pharmacology -- 1.2.6 Analytical and Bioanalytical Sciences -- 1.2.7 Regulatory Sciences -- 1.3 Small- Versus Large-Molecule Paradigms |
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1.3.1 Preclinical Discovery and Toxicology Assessment -- 1.3.2 Pharmaceutical Development -- 1.3.3 Clinical Development -- 1.4 Contemporary Drug Discovery Case Studies -- 1.4.1 Statins -- 1.4.2 Immuno-Oncology -- 1.5 Artificial Intelligence (AI) in Drug Discovery -- 1.5.1 How Is AI Being Used in Drug Design? -- 1.5.1.1 Target Identification -- 1.5.1.2 Molecular Simulations -- 1.5.1.3 Prediction of Drug Properties -- 1.5.1.4 De-Novo Drug Design -- 1.5.1.5 Candidate Drug Prioritization -- 1.5.1.6 Synthesis Pathway Generation -- 1.5.1.7 Assistance in Disease Diagnosis -- 1.5.2 AI Techniques |
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1.5.2.1 Heuristics -- 1.5.2.2 Support Vector Machines (SVM) -- 1.5.2.3 Artificial Neural Networks (ANN) -- 1.5.2.4 Markov Decision Process (MDP) -- 1.5.2.5 Natural Language Processing (NLP) -- 1.5.3 Machine Learning in Drug Design and Drug Discovery -- 1.5.3.1 Supervised Machine Learning -- 1.5.3.2 Un-Supervised Machine Learning -- 1.5.3.3 Semi-Supervised Machine Learning -- 1.5.3.4 Reinforcement Learning -- 1.5.4 Deep Learning in Medicine -- 1.5.5 Limitations of Utilizing AI for Drug Discovery -- 1.6 Summary and Outlook to the Future -- Review Questions -- References -- 2 Drug Development |
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2.1 Introduction -- 2.2 Stage-Gate Process of New Drug Discovery and Development -- 2.2.1 Preclinical Development -- 2.2.1.1 Physicochemical Characterization -- 2.2.1.2 Efficacy Studies -- 2.2.1.3 Toxicology Studies -- 2.2.2 Clinical Development -- 2.2.2.1 Phase I Clinical Trials -- 2.2.2.2 Phase II Clinical Trials -- 2.2.2.3 Phase III Clinical Trials -- 2.2.2.4 Evolving Clinical Development Paradigms -- 2.3 Pharmaceutical Development -- 2.3.1 Preformulation and Formulation Studies -- 2.3.2 Stage-Appropriate Drug Product Design -- 2.3.3 Stability -- 2.3.4 Bioavailability |
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2.3.5 Manufacturability -- 2.4 Regulatory Approval -- 2.4.1 Investigational New Drug Application -- 2.4.2 New Drug Application -- 2.4.2.1 Basis of Approval -- 2.4.2.2 Role of Advisory Committees -- 2.4.3 Biologics License Application -- 2.4.4 Abbreviated New Drug Application -- 2.4.5 Biosimilars -- 2.4.6 Approval and Post-Marketing Surveillance -- 2.4.7 Accelerated Development/Review -- 2.5 Post-Commercialization Activities -- 2.5.1 Manufacturing Support -- 2.5.2 Intellectual Property -- 2.5.3 Life Cycle Management -- Review Questions -- Further Readings -- 3 Pharmaceutical Considerations |
| Summary |
Completely revised and updated, this fourth edition elucidates the principles of pharmaceutics, biopharmaceutics, dosage form design, and drug delivery - including emerging new biotechnology-based treatment modalities. The authors integrate aspects of physical pharmacy, chemistry, biology, and biopharmaceutics into drug delivery |
| Notes |
Description based upon print version of record |
|
3.1 Introduction |
| Form |
Electronic book
|
| Author |
Narang, Ajit S
|
|
Kumar, Virender
|
| ISBN |
9781040154861 |
|
1040154867 |
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