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This book illustrates the significance and relevance of immunotherapy in modern-day therapeutics. Focusing on the application of immunotherapy in oncology, neurodegenerative and autoimmune diseases, it discusses the drug delivery systems, and pre-clinical and clinical methodologies for immunotherapy-based drugs. It also comprehensively reviews various aspects of immunotherapy, such as regulatory affairs, quality control, safety, and pharmacovigilance. Further, the book discusses the in vitro validation of therapeutic strategies prior to patient application and management of immunotherapy-related side effects and presents case studies demonstrating the design and development (pre-clinical to clinical) of immunotherapy for various diseases. It also describes various design considerations and the scale-up synthesis of immunotherapeutics and screening methods. Lastly, it explores the important aspect of cost-effectiveness and rational immunotherapystrategies.

In this volume, the specific challenges and problems facing the evaluation of new oncology agents are explored with regards to pharmacokinetic, pharmacodynamic modeling and clinical pharmacology development strategies. This book delivers, with an emphasis on the oncology therapeutic area, the goals set in the first three volumes: namely – to provide clinical pharmacologists practical insights for the application of pharmacology, pharmacokinetics and pharmacodynamics for new drug development strategies. Pharmacokinetic-pharmacodynamic concepts for tyrosine kinases, the evaluation of cardiac repolarization prolongation through QTc interval effects, efficacy- and safety-response analyses to support new drug approvals, clinical and preclinical tumor growth modeling, and flat- vs weight-based dose selection are showcased from an oncology clinical pharmacologist's point-of-view. Oncology development strategies are surveyed for new FDA-approvals to identify patterns in expectations at time of first approval. The special considerations necessary to address combination drug development, metronomics, biosimilars and breakthrough therapies are also presented.

Bladder cancer represents a major challenge to the oncologist. In spite of new tech­ niques for early diagnosis and innovative imaging procedures for staging, the outcome in terms of cure has not improved during the past ten years. Fortunately, about 74% of the patients present with localized disease, with 18% presenting with localized and regional disease, and 3% with distant metastases at diagnosis. In accordance with the stage at presentation, 94% of patients with localized disease are controlled at 5 years, as are 50% of patients with local and regional disease but un­ fortunately only 7% of those with distant disease. The survival data for Afro-Americans are more grave, with only 79% of patients with localized disease surviving at 5 years, 38% with local and regional disease, and 4% with disseminated disease. Even after 5 years, however, patients continue to fail not only locally and regionally but also with disseminated disease, thereby creating enigmas as to the continued influence of basic molecular changes, basic etiologic agents, and unsuspected more advanced disease, as well as demonstrating the inadequacies of local surgical treatment programs. These factors have led to braoder programs of combined integrated multimodal treatment earlier in the course of the disease process. Clearly, these newer innovative programs have placed increasing emphasis on the combination of surgery with radiation therapy and chemotherapy.