| Description |
1 online resource |
| Contents |
Biological Drug Products: Development and Strategies; Contents; Preface; Contributors; Part 1: General Aspects; 1 An Overview of the Discovery and Development Process for Biologics; 1.1 INTRODUCTION; 1.2 THE DISCOVERY PROCESS FOR MONOCLONAL ANTIBODIES; 1.2.1 Target Selection; 1.2.2 Screening Preparation; 1.2.3 Lead Selection and Optimization; 1.2.4 Selection of a Clinical Candidate; 1.2.5 Key Differences in the Discovery Process for Monoclonal Antibodies Versus Small Molecule Drugs; 1.3 MANUFACTURING PROCESS DEVELOPMENT FOR BIOLOGICS; 1.3.1 Introduction |
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1.3.2 Early Assessment of Discovery Candidate(s)1.3.3 Bioprocess Development and Manufacture; 1.3.4 Formulation Process Development and Manufacture; 1.3.5 Analytical Method Development and Manufacture; 1.3.6 Project Management and Critical Path to the Clinic; 1.4 REGULATORY REVIEWAND APPROVAL FOR BIOLOGICS; 1.4.1 US Drug Law; 1.4.2 Food and Drug Administration Overview; 1.4.3 Drug Development in the United States; 1.4.4 US Generic and Biosimilar Legislation; 1.5 BIOLOGICS: THE PAST, THE PRESENT, AND THE FUTURE; 1.5.1 Biosimilars; 1.5.2 Novel Scaffolds; 1.5.3 Drug Delivery |
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1.5.4 Immunogenicity1.5.5 Streamline the Drug Discovery and Development Process; 1.6 CONCLUSION; REFERENCES; 2 Nonclinical Safety Assessment of Biologics, Including Vaccines; 2.1 INTRODUCTION; 2.2 CONSIDERATIONS IN THE SELECTION OF THE ANIMAL SPECIES; 2.2.1 General Introduction; 2.2.2 Sequence Homology; 2.2.3 Target Affinity, Distribution, Biology, and Biochemical Pathways; 2.2.4 Use of Genetically Altered Rodents and Surrogate Antibodies; 2.2.5 Use of Animal Models of Disease; 2.3 CONSIDERATIONS FOR THE NONCLINICAL SAFETY EVALUATION; 2.3.1 Route of Administration |
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2.3.2 Selection of Doses for Toxicity Studies2.3.3 Safety Pharmacology; 2.3.4 General Toxicology Studies; 2.4 PHARMACOKINETICS; 2.4.1 Absorption; 2.4.2 Distribution; 2.4.3 Metabolism; 2.4.4 Excretion; 2.5 SELECTION OF THE INITIAL CLINICAL DOSE; 2.6 FUTURE DIRECTIONS; REFERENCES; 3 Clinical Assessment of Biologic Agents; 3.1 INTRODUCTION; 3.2 CLINICALTRIAL STRUCTURE; 3.2.1 Study Objective and Hypothesis Testing; 3.2.2 Standard Phases of Clinical Trials; 3.2.3 Types of Studies; 3.3 INCORPORATING PATIENTS INTO THE STRUCTURE OFATRIAL; 3.3.1 Treatment Groups and Cohort Enrichment |
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3.3.2 Comparative GroupsWithin Clinical Trials3.4 EFFICACY; 3.4.1 Endpoints; 3.5 PHARMACOVIGILANCE; 3.5.1 Adverse Side Effects; 3.6 DISEASES TREATED WITH BIOLOGICS; 3.6.1 Rheumatoid Arthritis; 3.6.2 Osteoporosis and Malignant Bone Metastasis; 3.6.3 Inflammatory Bowel Disease; 3.6.4 Psoriasis and Psoriatic Arthritis; 3.6.5 Reactive Airway Disease; 3.7 FUTURE PERSPECTIVES; REFERENCES; 4 Key Regulatory Guidelines for the Development of Biologics in the United States and Europe; 4.1 INTRODUCTION; 4.2 GENERAL UNITED STATES REGULATORY SCHEME |
| Summary |
Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for th |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Drug development.
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Drugs -- Research.
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Biological Products -- pharmacology
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Biological Products -- therapeutic use
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Drug Delivery Systems
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Drug Discovery
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Drug development
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Drugs -- Research
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| Form |
Electronic book
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| ISBN |
1299864651 |
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9781299864658 |
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9781118695036 |
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1118695038 |
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9781118148891 |
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1118148894 |
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