Drugs and the Pharmaceutical Sciences – serie

The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies.Features Comprehensive coverage of biotechnology science topics used in development and manufacturing Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved

This fully revised edition of Handbook of Pharmaceutical Granulation Technology covers the rapid advances in the science of agglomeration, process control, process modelling, scale-up, emerging particle engineering technologies, along with current regulatory changes presented by some of the prominent scientist and subject matter experts around the globe. Learn from more than 50 global subject matter experts who share their years of experience in areas ranging from drug delivery and pharmaceutical technology to advances in nanotechnology. Every pharmaceutical scientist should own a copy of this fourth edition resource.Key Features:Theoretical discussions covering granulation and engineering perspectives.Covers new advances in expert systems, process modelling and bioavailabilityChapters on emerging technologies in particle engineeringUpdated Current research and developments in granulation technologies

The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed.• Unique volume covering FDA inspections of GLP facilities• Provides a detailed interpretation of GLP Regulations• Presents the latest on electronic data management in GLP• Describes GLP and computer systems validation• Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements

Addressing the increased use of protein and peptide candidates as treatments for previously untreatable diseases, this comprehensive and progressive source provides the reader with a roadmap to an increased understanding of issues critical for successfully developing a protein or peptide therapeutic candidate. Proteins and Peptides is an invaluable source for drug discovery and development scientists in the biopharmaceutical industry who frequently navigate the maze of protein and peptide pharmacokinetics, pharmacodynamics, and metabolism. Key features include: issues related to delivery of protein and peptide therapeutics in elderly populations and pharmacogenomicslessons learned on the major marketed areas of proteins and peptides, including interleukins, interferons, growth factors, and peptide hormonesinnovations for protein and peptide delivery such as needle-less deliverystrategies for delivery of these molecules to locations such as the eye and brain generic issues of proteins and peptides

This up-to-the-minute Second Edition of an incomparable resource describes in detail the bases for developing dosage forms for use in animals-highlighting the data necessary to meet regulatory approval.Demonstrates the successful characterization, control, and registration of new veterinary medicines! Thoroughly rewritten and enlarged to reflect the technical advances that have occurred since the previous edition, Development and Formulation of Veterinary Dosage Forms, Second Editiondiscusses the reasons for dosage form selection explains the latest available technologies examines new drug therapeutics reveals up-to-date techniques and applications for pharmacokinetic data covers the formulation of products derived from biotechnology elucidates recent analytical methods shows how to determine the type of dosage form appropriate for particular species and more!Written by a team of international authorities from North America and Europe and containing over 1100 bibliographic citation, figures, and tables, Development and Formulation of Veterinary Dosage Forms, Second Edition is an essential reference for pharmaceutical, animal, and quality control scientists; research pharmacists and pharmacologists; veterinarians; drug quality assurance and regulatory personnel in government and industry; pathologists; microbiologists; virologists; physiologists; toxicologists; and upper-level undergraduate and graduate students in these disciplines.

This volume provides a single-source of reviews for all the important colloidal drug delivery systems, including nanoparticles, liposomes, niosomes, microemulsions and ointments. Over 1000 bibliographic citations, as well as tables, drawings, equations and photographs, are provided. Arranged in order of increasing physical complexity, this work analyzes developments in the field.

A comprehensive treatment of the science, technology, and regulation of rate-controlled administration of therapeutic agents, with coverage of the basic concepts, fundamental principles, biomedical rationales, and potential applications. This revised and updated edition (first in 1982) incorporates

This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development.Shows how to overcome pharmaceutical, technological, and economic constraints on experiment design!Directly comparing the advantages and disadvantages of specific techniques, Pharmaceutical Experimental Design· offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other books· reviews screening designs for qualitative factors at different levels· presents designs for predictive models and their use in optimization· highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirability· discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transfer· details nonstandard designs and mixtures· analyzes factorial, D-optimal design, and offline quality assurance techniques· reveals how one experimental design evolves from another· and more!Featuring over 700 references, tables, equations, and drawings, Pharmaceutical Experimental Design is suitable for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; statisticians and biostatisticians; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers, quality assurance personnel; all users of statistical experimental design in research and development; and postgraduate and postdoctoral research workers in these disciplines.

This book examines the sequence of events and methodology in the industrial clinical research process; a reference for multidisciplinary personnel. It is the conceptual framework involving the philosophical, economic, political, historical, regulatory, planning, and marketing aspects of the process.

The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies.Features Comprehensive coverage of biotechnology science topics used in development and manufacturing Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved

Pharmaceutical researchers are constantly looking for drug products, drug delivery systems and devices for improving the health of society. A scientific and systematic search for new knowledge requires a thorough understanding of research methods and hypothesis design. This volume presents pharmaceutical research through theoretical concepts, methodologies and ethical issues. It fulfils publication ethics course work requirements for students. Chapters have been designed to cater for the curriculum requirements of universities globally. This serves as a guide on how to apply concepts in designing experiments and transforming laboratory research into actual practice.Features:Complete coverage of research methodology courses for graduate and postgraduate students globallyStep-by-step assistance in writing technical reports, projects, protocols, theses and dissertationsExperimental designing in pharmaceutical formulation development and preclinical research designsEthics in using animals in preclinical research and humans in clinical researchPublication ethics, best practices and guidelines for ensuring ethical writingHypothetical and real-world case studies on ethical issues and measures for prevention and control

Pharmaceutical researchers are constantly looking for drug products, drug delivery systems and devices for improving the health of society. A scientific and systematic search for new knowledge requires a thorough understanding of research methods and hypothesis design. This volume presents pharmaceutical research through theoretical concepts, methodologies and ethical issues. It fulfils publication ethics course work requirements for students. Chapters have been designed to cater for the curriculum requirements of universities globally. This serves as a guide on how to apply concepts in designing experiments and transforming laboratory research into actual practice.Features:Complete coverage of research methodology courses for graduate and postgraduate students globallyStep-by-step assistance in writing technical reports, projects, protocols, theses and dissertationsExperimental designing in pharmaceutical formulation development and preclinical research designsEthics in using animals in preclinical research and humans in clinical researchPublication ethics, best practices and guidelines for ensuring ethical writingHypothetical and real-world case studies on ethical issues and measures for prevention and control

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability.Features:Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugsIncludes short stories about how some companies have adopted CM and what their drivers were and what benefits were realizedAddresses economic and practical considerations, unlike many other technical booksEmphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologiesHighlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies

Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the ‘why’ and the ‘how’, emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability.Features:Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugsIncludes short stories about how some companies have adopted CM and what their drivers were and what benefits were realizedAddresses economic and practical considerations, unlike many other technical booksEmphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologiesHighlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies

The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms.Key Features:Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipientsFocuses on equipment and process technologyExplains various extrusion system configurations as a manufacturing methodology for a variety of dosage formsPresents new opportunities available only via extrusion and future trendsIncludes contributions of experts from the process and equipment fields

Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many variables may impact the final product and its performance. This fourth edition of Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms aims to provide insight into the factors and parameters that should be considered and controlled for the successful development and commercialization of a coated product. The fourth edition has been revised and expanded to reflect the most recent scientific advancements from the literature. The contributing authors explain in detail, using illustrated examples, appropriate steps to solve and ideally avoid formulation, processing, and stability problems and to achieve an optimized dosage form. Trade names and chemical names of commercially marketed coatings are used throughout the text to help familiarize the reader with the various materials available for pharmaceutical applications. This book will be a valuable resource for anyone in the pharmaceutical industry working in the area of aqueous-based film coating.

This fully revised edition of Handbook of Pharmaceutical Granulation Technology covers the rapid advances in the science of agglomeration, process control, process modelling, scale-up, emerging particle engineering technologies, along with current regulatory changes presented by some of the prominent scientist and subject matter experts around the globe. Learn from more than 50 global subject matter experts who share their years of experience in areas ranging from drug delivery and pharmaceutical technology to advances in nanotechnology. Every pharmaceutical scientist should own a copy of this fourth edition resource.Key Features:Theoretical discussions covering granulation and engineering perspectives.Covers new advances in expert systems, process modelling and bioavailabilityChapters on emerging technologies in particle engineeringUpdated Current research and developments in granulation technologies

This book continues to be the definitive reference on drug metabolism with an emphasis on new scientific and regulatory developments. It has been updated based on developments that have occurred in the last 5 years, with new chapters on large molecules disposition, stereo-selectivity in drug metabolism, drug transporters and metabolic activation of drugs. Some chapters have been prepared by new authors who have emerged as subject area experts in the decade that has passed since publication of the first edition.Key Features:Continues to be the definitive reference on drug metabolismCovers the drug transporter field, disposition of protein therapeutics and metabolic activation of drugsIncludes the contributions of world-class experts in their respective fieldsContains the work of editors who are recognized leaders and deep content experts in the field of drug metabolismEmphasizes new scientific and regulatory developments in the field

Compaction of powder constituents—both active ingredient and excipients—is examined to ensure consistent and reproducible disintegration and dispersion profiles. Revised to reflect modern pharmaceutical compacting techniques, this second edition of Pharmaceutical Powder Compaction Technology guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel through the compaction formulation process and application. This unique reference covers: The physical structure of pharmaceutical compacts Bonding phenomena that occur during powder compaction Compression mechanisms of pharmaceutical particles Theories and basic principles of powder compaction New topics include: Compaction data analysis techniques The migration of powder constituents into commercial manufacture Instrumentation for compaction Compaction functionality testing, which is likely to become a USP requirement Design space for compaction Metrics required for scalability in tablet compression Interactive compaction and preformulation database for commonly used excipients

This book continues to be the definitive reference on drug metabolism with an emphasis on new scientific and regulatory developments. It has been updated based on developments that have occurred in the last 5 years, with new chapters on large molecules disposition, stereo-selectivity in drug metabolism, drug transporters and metabolic activation of drugs. Some chapters have been prepared by new authors who have emerged as subject area experts in the decade that has passed since publication of the first edition.

This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for hardware, applications, networks, data center operations, and complex software management practices in pharmaceutical manufacturing. Explains how the Food and Drug Administration's latest Good Manufacturing Process guidelines supporting electronic identification and electronic signatures for batch record registration together with computer system technologies will influence pharmaceutical production automation! Designed to provide quick and easy access to a whole range of system development topics, Automation and Validation of Information in Pharmaceutical Processingdefines a complete life-cycle methodology that integrates equipment, people, and information presents concepts, guidelines, test plans, example forms, and application details for previously unavailable computer system validation of complex automated information systems introduces, for the first time in depth, PQ testing of integrated manufacturing execution (MES) and manufacturing resource planning (MRP) applications describes how human resource programs maximize productivity gains for automation initiatives discusses approaches to automating batch operations with process control systems using industry examples and applicable computer technology concepts provides an outline for IQ, OQ, and PQ test plans for process control systems, including forms for use in testing instrumentation and distributed control system installation and operations employs a business analysis standpoint on life-cycle planning to justify new automation projects, including multiyear drug manufacturing plans documents the successful application of life-cycle methodologies to supply chain functions and much more! Together with references, tables, and drawings, Automation and Validation of Information in Pharmaceutical Processing is an essential, hands-on resource for pharmaceutical scientists, manufacturers, and engineers; drug quality assurance and regulatory personnel; project and program manufacturers; information system professionals and software developers and analysts; information technology practitioners; and graduate-level and continuing-education students in these disciplines.

Analyzes construction of experiments, focusing on variables, models, matrices, and reproducibility.This timely reference systematically examines the basic concepts and theoretical issues, methodologies for experiment and measurement, and practical health applications of emulsions and dispersions-describing formulation problems and identifying potential carriers for the delivery or targeting of new drugs.Evaluates anionic, cationic, and nonionic surfactants as dispersing, emulsifying, foaming, penetrating, and wetting agents.Written by more than 20 international researchers, Pharmaceutical Emulsions and Suspensionsdiscusses uses of macroemulsions and (submicron) microemulsions illuminates delivery devices such as microparticles, nanospheres, liposomes, and mixed micelles investigates the application of self-emulsifying drug delivery systems (SEDDS) introduces techniques for increasing drug solubility with nanosuspensions addresses stabilization, flocculation, and coagulation problems in pharmaceutical and cosmetic suspensions surveys drug delivery by way of dermatological, follicular, and ocular routes explains the pharmacodynamics, bioavailability, and pharmacokinetics in the drug formulation development process compares and contrasts monomeric and micellar adsorption at oil-water interfaces and more!Containing over 1800 references, tables, equations, drawings, and micrographs, Pharmaceutical Emulsions and Suspensions is an ideal resource for pharmacists; physical, surface, colloid, cosmetic, food, and agricultural chemists; and upper-level undergraduate and graduate students in these disciplines.

Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this multiauthored reference blends fundamental theory and practical advice on drug product stability in scientific, technical, and regulatory environments, covering development of indicating assays, computer use, clinical trial materials, strategic planning, and packaging. Describing the documentation required to minimize the changes of regulatory citations, the book lists manufacturers of photostability testing chambers, stability system software, and laboratory information management systems for pharmaceutical applications.

Delivering an encompassing overview of the factors, varieties, and applications determining product containment, this concise reference provides authoritative information on containment processes. It reviews the historical context, definition, evolution, and application of containment technology, analyzes a variety of containment techniques in new and retrofitted construction, and examines "people protection" vs. "product protection" and the role of source-contamination in each. It also suggests conceptualizing containment options from the inception of a project for economical, at-the-source containment, identifies containment requirements and monitoring methods, as well as the current state of emission controls, and discusses the "dustiness" of powders and how this research is being defined, quantified, and used in containment design.

This extensive reference/text explores the principles, instrumentation, processes, and programs of pharmaceutical solid science as well as new aspects on one-component systems, micromeritics, polymorphism, solid-state stability, cohesion, powder flow, blending, single- unit sustained release, and tablet coating.Reveals unique approaches in pharmaceutical solid science not previously published in any other text!Providing current data on crystallization, dissolution from particles and polydisperse populations, powder volumes and densities, comminution, wet granulation, and hard-shell capsules, Advanced Pharmaceutical Solids describes moisture isotherms with crystalline solids documents the effects of moisture on solid-state stability highlights tablet physics and principles explains sustained release by microencapsulation presents prediction equations for solubility in binary solvents discusses particle sizes and diameters identifies Brunauer, Emmett, and Teller Isotherms and more!Considering properties of solids, permeamitry and gas absorption methods, amorphates, and purification by pH-change precipitation, Advanced Pharmaceutical Solids is an essential reference for pharmacists; pharmaceutical scientists; medicinal, physical, surface, colloid, and analytical chemists and biochemists; and an effective text for upper-level undergraduate and graduate students in these disciplines.

This reference features the latest findings surrounding the physicochemical aspects of surfactant and polymer systems to facilitate the design and understanding of novel and advanced drug delivery formulations. It covers the basics of surfactant and polymer surface activity and self-assembly, the various types of structures formed by such compounds, and how they may be used in drug delivery. It also discusses solubilization of drugs in micellar systems, liquid crystalline phases formed by PEO-PPO-PEO block copolymers and other copolymers and surfactants, triggered drug-release from liposome formulations, microemulsions formed by ionic and nonionic surfactants, and much more.

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

This book is based on research papers and commentaries on pharmacokinetic methods and applications published since 1975. It offers detailed examinations of new developments in the pharmacokinetic field with enhanced clarity of presentation and simplified organization.