India and China have been identified by pharmaceutical companies as the future markets that
would support drug research and development in a cost efficient manner. This has become
necessary as resources to conduct clinical studies dwindle, coupled with the fact that
pharmaceutical industries are under pressure to deliver quality medicine, on time, to the public.
Exploring and examining India and China’s potential in a stepwise fashion provides the
opportunity to dissect the good, the bad and the ugly of globalization in a comparative approach.
This paper will cover areas like ethics in the conduct of studies, good clinical practice (GCP),
economic realities, ICH influence, intellectual property security and the role of government in
global clinical trial.
Inhaltsverzeichnis (Table of Contents)
- Globalization of clinical trials
- Indian drug regulatory body versus the Chinese system
Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)
This paper explores the impact of globalization on clinical trials, particularly in India and China. The author aims to analyze the benefits and challenges of conducting clinical trials in these emerging markets, comparing their regulatory frameworks and ethical considerations.
- Ethics in the conduct of clinical trials
- Good clinical practice (GCP) and global acceptance
- Intellectual property security
- The role of government in global clinical trials
- Economic realities of clinical trial outsourcing
Zusammenfassung der Kapitel (Chapter Summaries)
- Globalization of clinical trials: This chapter introduces the concept of globalization in clinical trials and explains the driving forces behind its growth, including the need for cost-efficient drug research and development. It also discusses the opportunities and challenges associated with conducting clinical trials in emerging markets like India and China.
- Indian drug regulatory body versus the Chinese system: This chapter focuses on the specific regulatory frameworks and challenges faced by pharmaceutical companies in India and China. It highlights the strengths and weaknesses of each country's system and how they are adapting to the influx of global clinical trials.
Schlüsselwörter (Keywords)
The main keywords and focus topics of this paper include globalization, clinical trials, India, China, regulatory frameworks, ethics, good clinical practice (GCP), intellectual property security, economic realities, and emerging markets.
- Citation du texte
- Ginika Egesimba (Auteur), 2013, The Comparative Impact of Globalization of Clinical Trials in India and China, Munich, GRIN Verlag, https://www.grin.com/document/214036
