Bücher der Reihe AAPS Advances in the Pharmaceutical Sciences Series

This volume is intended to provide the reader with a breadth of understanding regarding the many challenges faced with the formulation of poorly water-soluble drugs as well as in-depth knowledge in the critical areas of development with these compounds.

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.

Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure.

Transporters in Drug Development examines how membrane transporters can be dealt with in academic-industrial drug discovery and pharmaceutical development as well as from a regulatory perspective.

This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders.

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.

A vast number of diagnostic and therapeutic decisions are based on measuring blood concentrations of molecules, yet most biochemical and pharmacological events actually take place in the tissues.

Case studies are presented for the three ADCs that have received FDA approval: gemtuzumab ozogamicin (Mylotarg (R)), Brentuximab vedotin (Adcetris (R)), and ado-trastuzumab emtansine (Kadcyla (R)), as well as an ADC in late-stage clinical trials, glembatumumab vedotin (CDX-011).

This volume is intended to provide the reader with a breadth of understanding regarding the many challenges faced with the formulation of poorly water-soluble drugs as well as in-depth knowledge in the critical areas of development with these compounds.

This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas.

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.

The volume aim to be a comprehensive overview of the drug and biologic development process that is often called "the valley of death" (pre-IND through approval) where high costs of studies and high rates of product failure are part of the drug development landscape.

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

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.

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 handbook covers established and advanced techniques for biomarker analysis, such as guidelines and strategies for assay validation methods;

Natural products and functional/medical foods are now widely acknowledged as having an effect on the microbiome of the intestine, which in turn influences the outcome of certain disease.

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).

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.

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.