Formulating and implementing pharmaceutical pricing policies: Challenges, case studies and lessons learned from medicine price control provides readers with a framework to understand and analyze several medicine pricing policies. Through case studies from countries across geographies and income tiers, the book explores the challenges and opportunities related to price control experiences.Studying policies from Australia, New Zealand, China, the European Union, South Africa, India among other countries, the book discusses approaches, strategies, and the underlying pharmaceutical pricing practices used to provide advice for formulating highly effective policies. Alongside the cases, this book covers appropriate research methods for pricing analysis, the essential components of pricing policy, data quality, and the generic structure of a pharmaceutical pricing policy.Formulating and implementing pharmaceutical pricing policies: Challenges, case studies and lessons learned from medicine price control discusses how a medicine pricing policy is formed, why they differ from country to country based on the local health system, and what results can be achieved. This book is an important reference for pharma professionals, regulatory agencies, and policy makers. Researchers investigating Pharmacoeconomics, and overall healthcare cost will also benefit from the analysis framework described in this book.
Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing. The book comprehensively covers the entire clinical trial process of conductance. In addition, the author also incorporates the clinical trial approval processes of USFDA, EMA, and JAPAN for conducting clinical trials.
Evidence-Based Validation of Herbal Medicines brings together current thinking and practice in the areas of characterization and validation of natural products. This book reviews all aspects of evaluation and development of medicines from plant sources, including their cultivation, collection, phytochemical and phyto-pharmacological evaluation, and therapeutic potential. Emphasis is placed on describing the full range of evidence-based analytical and bio-analytical techniques used to characterize natural products, including –omic technologies, phyto-chemical analysis, hyphenated techniques, and many more.