Bøger i AAPS Advances in the Pharmaceutical Sciences Series serien

Tackling translational medicine with a focus on the drug discovery development-interface, this book integrates approaches and tactics from multiple disciplines, rather than just the pharmaceutical aspect of the field.

This inclusive text describes 3D Printing for pharmaceutical applications, including emerging 3D technologies. The book focuses on the functionality of the materials/biomaterials used for the preparation of dosage forms and devices, fundamentals for preparing these systems and novel applications using these additive manufacturing techniques. Also, the text includes clinical relevance and regulatory considerations for the future of personalized medicine.Authored by experts with a broad range of experience, extensive insight into the science of 3D printing technology used to produce these systems is provided. Highlighting viewpoints from the academic, polymer excipient, equipment, product development and regulatory communities, this comprehensive text compiles input from industry thought leaders to illustrate strategies and technologies for applying techniques of additive manufacturing for drug product and device development whilealso providing insight into the path forward for the technology in years to come.

Tackling translational medicine with a focus on the drug discovery development-interface, this book integrates approaches and tactics from multiple disciplines, rather than just the pharmaceutical aspect of the field.

Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents.

This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules.

Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various  BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.

The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs).

This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population.

The examples illustrate how results from all phases of drug development can be integrated in a more timely and cost-effective process.Applying pharmacometric decision tools during drug development can allow objective, data-based decision making.

This book addresses key concepts and applications in sterile product development. Throughout, it illustrates key concepts relevant to the successful development of sterile products with the help of case studies.

It contains methods descriptions for studying drug delivery, routes and approaches of administering drugs into the brain, the influence of disease, and drug industry perspectives.

He is the European Editor of the International Journal of Pharmaceutics.Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award.

While systems biology and pharmacodynamics have evolved in parallel, there are significant interrelationships that can enhance drug discovery and enable optimized therapy for each patient.

Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents.

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development.

It provides an overview of nanotechnology in drug delivery with a description of different types of nanoparticles, methods of preparation and characterization, and functionalization for site-specific drug delivery.

This book elaborates on drug delivery targeting via intracellular delivery, specifically through the Receptor Mediated Endocytosis (RME) approach, due to the involvement of cellular receptors in various grave diseases.

While systems biology and pharmacodynamics have evolved in parallel, there are significant interrelationships that can enhance drug discovery and enable optimized therapy for each patient.

This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population.

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows:Section I: Business, Health Economics and Intellectual Property Landscape for BiosimilarsSection II: Regulatory Aspects of Development and Approval for BiosimilarsSection III: Biopharmaceutical Development and Manufacturing of BiosimilarsSection IV: Analytical Similarity Considerations for BiosimilarsSection V: Clinical aspects of Biosimilar DevelopmentSection VI: Biosimilars- Global Development and Clinical ExperienceChapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.

Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

He is the European Editor of the International Journal of Pharmaceutics.Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award.

This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products.FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.

Basic Principles of Continuous Manufacturing.- Continuous Reactors for Pharmaceutical Manufacturing.- Understanding Residence Time, RTD, and Impact of Surge Vessels.- Practical Considerations for Continuous Drug Substance Manufacturing.- Continuous Crystallization: Equipment and Operation.- Continuous Feeding-Blending in Pharmaceutical Continuous Manufacturing.- Recent Progress in Roll Compaction Process Development for Pharmaceutical Solid Dosage Form Manufacture.- Continuous wet granulation processes.- Fluidized Bed Drying.- Statistical Methods in Quality by Design and Process Analytical Technologies for continuous processes to enable real-time release.- Active Process Control in Pharmaceutical Continuous Manufacturing-The Quality by Control (QbC) Paradigm.- Real-time Optimization in Pharmaceutical Manufacturing.- Safety Guidelines for Continuous Chemistry Experimental Work in the Laboratory.- Evaluating the Busieness/Supply Chain Benefits of Continuous Processing in Pharmaceuticals.- Regulatory Considerations for Continuous Manufacturing.