Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have...

Title Page -- Copyright Page -- Contents -- List of Contributors -- Preface -- Chapter 1 Introduction -- 1.1 Quality by Design Overview -- 1.2 Pharmaceutical Industry -- 1.3 Quality by Design Details -- 1.4 Chapter Summaries -- References -- Chapter 2 An Overview of the Role of Mathematical...

Structured like a textbook, the second edition of this referencecovers all aspects of biopharmaceutical manufacturing, includinglegal and regulatory issues, production facility design, andquality assurance, with a focus on supply chain management andregulations in emerging markets and cost...

Objectives: Many European countries regulate the markets for prescription drugs in order to cope with rising health expenditures. On the other hand, regulation distorts incentives to invest in pharmaceutical R&D. This study aims at empirically assessing the impact of regulation on pharmaceutical...