This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

Accurately calculating medication dosages is a critical element in pharmaceutical care that directly effects optimal patient outcomes. Unfortunately, medication dosage errors happen in pharmacies, in hospitals, or even at home or in homecare settings everyday. In extreme cases, even minor dosage errors can have dire consequences. Careful calculations are essential to providing optimal medical and pharmaceutical care.

Essential Math and Calculations for Pharmacy Technicians fills the need for a basic reference that students and professionals can use to help them understand and perform accurate calculations. Organized in a natural progression from the basic to the complex, the book includes:

· Roman and Arabic Numerals
· Fractions and decimals
· Ratios, proportions, and percentages
· Systems of measurement including household conversions
· Interpretation of medication orders
· Isotonicity, pH, buffers, and reconstitutions
· Intravenous flow rates
· Insulin and Heparin products
· Pediatric dosage
· Business math

Packed with numerous solved examples and practice problems, the book presents the math in a step-by-step style that allows readers to quickly grasp concepts. The authors explain the fundamentals simply and clearly and include ample practice problems that help readers become proficient. The focus on critical thinking, real-life problem scenarios, and the self-test format make Essential Math and Calculations for Pharmacy Technicians an indispensable learning tool.

This book is directed to the student or professional who has difficulty with basic pharmacy math. It covers Roman and Arabic numerals, fractions, decimals, ratios, proportions, percentages, systems of measurement including household conversions, and interpretation of medication orders.