FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures.
New Look to Phytomedicine: Advancements in Herbal Products as Novel Drug Leads is a compilation of in-depth information on the phytopharmaceuticals used in modern medicine for the cure and management of difficult-to-treat and challenging diseases.
The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities.
Biomaterials and Bionanotechnology examines the current state of the field within pharmaceutical sciences and concisely explains the history of biomaterials including key developments.
Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments.
Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments.
The Core Model: A Collaborative Paradigm for the Pharmaceutical Industry and Global Health Care develops the innovative core model, an organizational research and design paradigm and economic theory that proposes a collaborative approach to resolving global health issues and improving the productivity of drug development.
Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries.
How companies are using lean development to revolutionize their product and service offerings-vital lessons any business leader can use as an engine of innovationHow did Ford Motors use Lean Development to pull off one of the most impressive corporate turnarounds in history?
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances.
Profiles of Drug Substances, Excipients, and Related Methodology, Volume 42 presents comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients, thus meeting the needs of the pharmaceutical community and allowing for the development of a timely vehicle for publishing review materials on the topic.
Microforming Technology: Theory, Simulation and Practice addresses all aspects of micromanufacturing technology, presenting detailed technical information and the latest research developments.
Total Quality Management: Key Concepts and Case Studies provides the full range of management principles and practices that govern the quality function.
An Industrial IoT Approach for Pharmaceutical Industry Growth, Volume Two uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches and make discoveries.
Advances and Avenues in the Development of Novel Carriers for Bioactives and Biological Agents provides sound data on the utility of biological and plant-based drugs and describes challenges faced in all aspects offering indispensable strategies to use in the development of bioactive medicines.
Nanotechnology-Based Approaches for Targeting and Delivery of Drugs and Genes provides an overview of the important aspects of nanomedicine in order to illustrate how to design and develop novel and effective drug delivery systems using nanotechnology.
Theory and Methods of Metallurgical Process Integration analyzes the basic elements and characteristics of steel manufacturing processes and operation, also proposing a theory of precise dynamic design and integration of steel plants.
Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations.
Conservation for the Anthropocene Ocean: Interdisciplinary Science in Support of Nature and People emphasizes strategies to better connect the practice of marine conservation with the needs and priorities of a growing global human population.
Metabolomics and Microbiomics: Personalized Medicine from the Fetus to the Adult encompasses the most recent advances on the usage of metabolomics and microbiome research to improve disease diagnosis and healthcare.
Preserving the Promise: Improving the Culture of Biotech Investment critically examines why most biotech startups fail, as they emerge from universities into an ecosystem that inhibits rather than encourages innovation.
Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients.
How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source.
Modeling of Microscale Transport in Biological Processes provides a compendium of recent advances in theoretical and computational modeling of biotransport phenomena at the microscale.
Microsized and Nanosized Carriers for Nonsteroidal Anti-Inflammatory Drugs: Formulation Challenges and Potential Benefits provides a unique and complete overview of novel formulation strategies for improvement of the delivery of NSAIDs via encapsulation in microsized and nanosized carriers composed of different materials of natural and synthetic origin.
Drug Design and Discovery in Alzheimer's Disease includes expert reviews of recent developments in Alzheimer's disease (AD) and neurodegenerative disease research.
Pharmacology in Drug Discovery and Development: Understanding Drug Response, Second Edition, is an introductory resource illustrating how pharmacology can be used to furnish the tools necessary to analyze different drug behavior and trace this behavior to its root cause or molecular mechanism of action.
Management of Hemostasis and Coagulopathies for Surgical and Critically Ill Patients: An Evidence-Based Approach offers a concise guide to a sub-specialty of transfusion medicine from the clinical laboratory perspective.
Nano- and Microscale Drug Delivery Systems: Design and Fabrication presents the developments that have taken place in recent years in the field of micro- and nanoscale drug delivery systems.
Published continuously since 1944, the Advances in Protein Chemistry and Structural Biology series has been the essential resource for protein chemists.
Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations.
Project Management in Product Development: Leadership Skills and Management Techniques to Deliver Great Products is written for new and aspiring project managers in product development.
Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India.
Genetically Modified Organisms in Food focuses on scientific evaluation of published research relating to GMO food products to assert their safety as well as potential health risks.
Targeted Nanomedicine for Breast Cancer Therapy provides a compilation of treatment approaches for breast cancer, including conventional receptor targeting methods and novel strategies like stimuli responsive methods and tumor micro-environment responsive strategies.
Food Safety and Quality Systems in Developing Countries, Volume 2: Case Studies of Effective Implementation begins with a general overview of some of the issues and considerations that impact effective implementation of food safety and quality systems and put this in the context of some of the more noteworthy foodborne illness incidents in the recent past.
Of the thousands of novel compounds that a drug discovery project team invents and that bind to the therapeutic target, only a fraction have sufficient ADME (absorption, distribution, metabolism, elimination) properties, and acceptable toxicology properties, to become a drug product that will successfully complete human Phase I clinical trials.
Regulating Safety of Traditional and Ethnic Foods, a compilation from a team of experts in food safety, nutrition, and regulatory affairs, examines a variety of traditional foods from around the world, their risks and benefits, and how regulatory steps may assist in establishing safe parameters for these foods without reducing their cultural or nutritive value.
Laboratory Animal Anaesthesia, Fourth Edition provides a basic guide to anaesthesia for a very diverse audience needing content, with straight-forward, structured style of writing.
Mesenchymal stem cell-derived exosomes are at the forefront of research in two of the most high profile and funded scientific areas - cardiovascular research and stem cells.
Food Waste Recovery: Processing Technologies and Industrial Techniques acts as a guide to recover valuable components of food by-products and recycle them inside the food chain, in an economic and sustainable way.
Project Management in Product Development: Leadership Skills and Management Techniques to Deliver Great Products is written for new and aspiring project managers in product development.
Product development teams are composed of an integrated group of professionals working from the nascent stage of new product planning through design creation and design review and then on to manufacturing planning and cost accounting.
Commercial Aircraft Hydraulic Systems: Shanghai Jiao Tong University Press Aerospace Series focuses on the operational principles and design technology of aircraft hydraulic systems, including the hydraulic power supply and actuation system and describing new types of structures and components such as the 2H/2E structure design method and the use of electro hydrostatic actuators (EHAs).
