Pharmaceutical Manufacturing & Medical Laboratory Sciences

Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.

The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)'‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors, and this comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects.

This textbook is the first to present a systematic introduction to chemical analysis of pharmaceutical raw materials, finished pharmaceutical products, and of drugs in biological fluids, which are carried out in pharmaceutical laboratories worldwide. In addition, this textbook teaches the fundamentals of all the major analytical techniques used in the pharmaceutical laboratory,and teaches the international pharmacopoeias and guidelines of importance for the field. It is primarily intended for the pharmacy student, to teach the requirements in “analytical chemistry”.

Biosafety in the Laboratory is a concise set of practical guidelines for handling and disposing of biohazardous material. The consensus of top experts in laboratory safety, this volume provides the information needed for immediate improvement of safety practices. It discusses high- and low-risk biological agents (including the highest-risk materials handled in labs today), presents the "seven basic rules of biosafety," addresses special issues such as the shipping of dangerous materials, covers waste disposal in detail, offers a checklist for administering laboratory safety.

Provides step-by-step protocols and descriptions that enable clinical microbiologists and laboratory staff personnel to perform all analyses, including appropriate quality control recommendations, from the receipt of the specimen through processing, testing, interpretation, presentation of the final report, and subsequent consultation.

Laboratory Safety for Chemistry Students is designed to teach the the skills and knowledge needed to stay safe while working in any lab. This new principles-based approach treats lab safety as a distinct, essential discipline of chemistry. As students progress through the text, they'll learn about laboratory and chemical hazards, about routes of exposure, about ways to manage these hazards, and about handling common laboratory emergencies. Most importantly, they'll learn that it is very possible to safely use hazardous chemicals in the laboratory by applying safety principles that prevent and minimize exposures.

Use this comprehensive resource to gain the theoretical and practical knowledge you need to be prepared for classroom tests and certification and licensure examinations.

Mollison's Blood Transfusion in Clinical Medicine is an icon in the field of transfusion and the first edition was published in 1951. The book arose from the concept of the transfusionist, as both scientist and expert consultant. For many years, this text has provided the primary, and often the sole, reference for detailed information and practical experience in blood transfusion. The book is completely revised and updated throughout to include the latest advances and developments in the field.