Cargando…
Biological Drug Products : Development and Strategies.
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 regulat...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Wiley,
2013.
|
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 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
- 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
- 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
- 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
- 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