We have shared a review and a free pdf download link (Google Drive) of ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins: Applications in Drug Discovery and Development PDF.
With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan, and implement end-to-end translational research for biologic drugs. It includes coverage of cutting-edge research, lessons learned from small molecule ADME, and the utility of ADME to guide lead optimization, first-in-human dose projection, and clinical development towards regulatory registration for monoclonal antibodies and therapeutic proteins with novel scaffold-like ADCs and bispecific.
In addition, case studies address leveraging ADME knowledge for guiding biologics drug development. Industry perspectives and regulatory expectations describe drug development strategies for both innovator and biosimilar therapeutic proteins.
- 1 Features of ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins.
- 2 Table Of Content.
- 3 ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins PDF Download.
Features of ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins.
With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs.
- Details cutting-edge ADME (absorption, distribution, metabolism, and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biological drugs.
- Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective.
- Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecific, and vaccines.
- Presents regulatory expectations and industry perspectives for developing biologic drugs in the USA, EU, and Japan.
- Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain.
Table Of Content.
LIST OF CONTRIBUTORS
- ADME for Therapeutic Biologics: What Can We Leverage from Great Wealth of ADME Knowledge and Research for Small Molecules
- Protein Engineering: Applications to Therapeutic Proteins and Antibodies
- Therapeutic Antibodies—Protein Engineering to Influence ADME, PK, and Efficacy
- ADME for Therapeutic Biologics: Antibody]Derived Proteins and Proteins with Novel Scaffolds
- Overview of ADME and PK/PD of ADCs
- Role of Lymphatic System in Subcutaneous Absorption of Therapeutic Proteins
- Biodistribution of Therapeutic Biologics: Methods and Applications in Informing Target Biology, Pharmacokinetics, and Dosing Strategies
- Prediction of Human Pharmacokinetics for Protein]Based Biologic Therapeutics
- Fixed Dosing versus Body size Based Dosing for Therapeutic Biologics—A Clinical Pharmacology Strategy
- Impact of Diseases, Comorbidity, and Target Physiology on ADME, PK, and PK/PD of Therapeutic Biologics
- Immunogenicity: Its Impact on ADME of Therapeutic Biologics
- Mechanistic Physiologically Based Pharmacokinetic
- Integrated Quantitation of Biotherapeutic Drug–Target Binding, Biomarkers, and Clinical Response to Support Rational Dose Regimen Selection
- Target Driven Pharmacokinetics of Biotherapeutics
- Target Driven Pharmacokinetics of Biotherapeutics
- Tumor Effect Site Pharmacokinetics: Mechanisms and Impact on Efficacy
- Brain Effect Site Pharmacokinetics: Delivery of Biologics Across the Blood-Brain Barrier
- Molecular Pathology Techniques in the Preclinical Development of Therapeutic Biologics
- Labeling and Imaging Techniques for Quantification of Therapeutic Biologics
- Knowledge of ADME of Therapeutic Proteins in Adults Facilitates Pediatric Development
- LC/MS versus Immune Based Bioanalytical Methods in Quantitation of Therapeutic Biologics in Biological Matrices
- Biosimilar Development: Nonclinical and Clinical Strategies and Challenges with a Focus on the Role of PK/PD Assessments
- ADME Processes in Vaccines and PK/PD Approaches for Vaccination Optimization
- Drug Development Strategies for Therapeutic Biologics: Industry Perspectives
- Review: The Critical Role of Clinical Pharmacology in the Development of Biologics
- Investigating the Nonclinical ADME and PK/PD of an Antibody-Drug Conjugate: A Case Study of Trastuzumab Emtansine
- Use of PK/PD Knowledge in Guiding Bispecific Biologics Research and Development
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