Drug Development for Rare Diseases (Chapman & Hall/CRC Biostatistics Series)

A disease is defined as rare if the prevalence is fewer than 200,000 in the United States. It is estimated that there are more than 7,000 rare diseases, which collectively affect 30 million Americans or 10% of the US population. This diverse and complex disease area poses challenges for patients, caregivers, regulators, drug developers, and other stakeholders. This book is proposed

to give an overview of the common issues facing rare disease drug developers, summarize challenges specific to clinical development in small populations, discuss drug development strategies in the evolving regulatory environment, explain generation and utilization of different data and evidence

inside and beyond clinical trials, and use recent examples to demonstrate these challenges and the development strategies that respond to the challenges.

Key Features:

• Rare disease.

• Drug development.

• Innovative clinical trial design.

• Regulatory approval.

• Real-world evidence.

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Description

Drug Development for Rare Diseases (Chapman & Hall/CRC Biostatistics Series)

By Bo Yang (Editor), Yang Song (Editor), Yijie Zhou (Editor)

Key Features:

Rare Diseases: Explores the prevalence and complexity of rare diseases, which affect 30 million Americans (10% of the US population) and pose unique challenges for treatment.
Drug Development: Discusses the specific challenges faced by drug developers working on rare diseases and strategies for overcoming them.
Innovative Clinical Trial Design: Focuses on innovative approaches to clinical trials for small patient populations, addressing the difficulties in recruitment and data collection.
Regulatory Approval: Examines the evolving regulatory environment and strategies for obtaining approval for treatments targeting rare diseases.
Real-World Evidence: Highlights the importance of real-world data in supplementing clinical trials and demonstrating the effectiveness of treatments beyond controlled settings.

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