Clinical Research in Asia: Opportunities and Challenges for the Contract Research Organisation Industry Authors: Umakanta Sahoo No of Pages: 250 Year of Publishing: 2011 Description: Asia is rapidly emerging as the new hub of clinical research - due to the enormous Over the last decade, an increased number of clinical trials globally are being carried out by Contract Research Organisations (CROs) in Asian countries, such as Japan, China, India, Taiwan, Singapore, South Korea, Thailand, Malaysia, Philippines and Vietnam. Good Clinical Research Practice (GCP) has rapidly developed across the region in order to harmonise the global standards to meet the increased demands of clinical research trials and lingering concerns about ethics in the Asian region for clinical research trials. Recent changes in US and European regulation and regulatory practices also play a role in the global emphasis on GCP and a renewed basis for ethics. The book is divided into 10 main chapters covering the top countries in Asia in the sector.
Key Statistical Concepts in Clinical Trials for Pharma Authors: J. Rick Turner No of Pages: 70 Year of Publishing: 2011 Description: This Brief discusses key statistical concepts that facilitate the inferential analysis of data collected from a group of individuals participating in a pharmaceutical clinical trial, the estimation of their clinical significance in the general population of individuals likely to be prescribed the drug if approved, and the related decisionmaking that occurs at both the public health level (by regulatory agencies when deciding whether or not to approve a new drug for marketing) and the individual patient level (by physicians and their patients when deciding whether or not the patient should be prescribed a drug that is on the market). These concepts include drug safety and efficacy, statistical significance, clinical significance, and benefit-risk balance.
Contract Research and Development Organizations: Their Role in Global Product Development Authors: Shayne C Gad and Charles B Spainhour No of Pages: 224 Year of Publishing: 2011 Description: Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants.
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