This item is in: Biomedicine > Pharmaceutical science/technology, drug delivery
Clinical research in Asia: Opportunities and challengesU Sahoo, Chiltern, India
Woodhead Publishing Series in Biomedicine No. 10
An important contribution to the field of global research ethics
Doody's Book Reviews
- analysis from a leading and highly respected professional in the sector
- an overview of country-specific regulatory environments
- discussion of challenges and solutions for clinical research
- overview of technological advances in the field
- analysis of investment patterns and business models, including outsourcing and Public Private Partnership
Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis).
ISBN 1 907568 00 X
ISBN-13: 978 1 907568 00 8
May 2012
412 pages 234 x 156mm hardback
£125.00 / US$210.00 / €150.00
Usually dispatched within 24 hours
About the author
Dr Umakanta Sahoo is Executive Director for Asia Pacific and Managing Director for India at Chiltern, a Contract Research Organisation. He is a bioscience graduate with an MBA and PhD in Management, and has over 17 years of experience in the pharmaceutical industry and CRO sector.
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Contents
Clinical research in Asia: a brief overview
- Background
- Global pharmaceutical market
- Clinical research business – a global overview
- CRO services mix
- The clinical research boom in Asia
- Asian country segmentation analysis
- Clinical trials in Asia
- Inspection and data quality
- Clinical research in Asia – SWOT analysis
Clinical research in Japan
- Background and history
- Clinical research industry in Japan
- The regulatory environment in Japan
- Evolution of Japanese good clinical practice
- Global clinical trials in Japan
- Emerging outsourcing models in Japan
Clinical research in India
- Pharmaceutical industry background
- History of clinical research in India
- Evolution of clinical research in India
- Regulatory environment in India
- Clinical trial approval
- Difference between ICH-GCP and Indian GCP
- Regulatory inspections in India
- Clinical research in India: PESTLE analysis
- Future outlook
Clinical research in China
- Pharmaceutical market
- Pharmaceutical investments in China
- China’s healthcare system
- Healthcare delivery system
- The importance of traditional medicine in modern healthcare
- China’s CRO market
- Clinical trials in China
- Accreditation of clinical trial sites in China
- Clinical research in China – environmental analysis
- Future outlook
Clinical research in South Korea
- Pharmaceutical industry overview
- CRO market in South Korea
- Clinical trial environment
- Evolution of GCP in South Korea
- Clinical trials in South Korea
- Accreditation of medical centres
- Environmental analysis
- Future outlook
Clinical research in Taiwan
- Pharmaceutical industry overview
- Biotech industry in Taiwan
- Healthcare system in Taiwan
- CRO market in Taiwan
- Evolution of GCP in Taiwan
- Clinical trials in Taiwan
- Future outlook
Clinical research in Singapore
- Overview of the pharmaceutical industry in Singapore
- Pharmaceutical investments in Singapore
- Governing authority and regulatory structure
- Healthcare system in Singapore
- Clinical research in Singapore
- CRO market
- Clinical trials in Singapore
- Evolution of GCP in Singapore
- Role of clinical trial resource centre
- Environmental analysis
- Clinical trial challenges
- Future outlook
Clinical research in Thailand
- Pharmaceutical industry in Thailand
- The pharmaceutical regulatory environment
- Pharmaceutical market
- Clinical research in Thailand
- CRO market in Thailand
- Hospital systems in Thailand
- Conducting clinical trials in Thailand
- Clinical trials in Thailand
- Environmental analysis
- Future outlook
Clinical research in Malaysia
- Pharmaceutical industry overview
- Pharmaceutical market
- Pharmaceutical regulation
- Healthcare systems in Malaysia
- Clinical trial environment
- Regulatory environment in Malaysia
- Evolution of Malaysian GCP
- CRO market in Malaysia
- Clinical trials in Malaysia
- Registration of clinical trials
- Challenges and future outlook
Clinical research in Hong Kong
- Background and history
- Pharmaceutical industry in Hong Kong
- Healthcare system in Hong Kong
- Clinical trials in Hong Kong
- The regulatory environment
- Clinical trials in Hong Kong
- Environmental analysis
- Future outlook
Clinical research in the Philippines, Indonesia and Vietnam
- Clinical research in the Philippines
- Clinical research in Indonesia
- Clinical research in Vietnam
Conclusions
- PESTLE analysis
- Political environment
- Economic environment
- Socio-cultural forces
- Technological factors
- Legal environment
- Other environmental factors
- Strategic issues for the CRO industry
- Future outlook
Bibliography