Providing a significant cross-fertilization of ideas across several disciplines, Enhancement in Drug Delivery offers a unique comprehensive review of both theoretical and practical aspects of enhancement agents and techniques used for problematic administration routes. It presents an integrated evaluation of absorption enhancers and modes for promoting absorption that is especially valuable to those involved with the development of pharmaceutical, cosmetic, bioengineered, and medical products, as well as graduate students looking to study this intriguing field and those professionals involved with patents and regulatory issues. Organized by routes of administration, the book is divided into eight major sections: oral, rectal, buccal/sublingual, dermal/transdermal, nasal, vaginal/uterine, ocular, and brain. It offers fundamental as well specialized information including current findings on- * Surfactant use to accelerate macromolecule input * Targeted gastrointestinal delivery and enhanced absorption of lipophilic drugs * Permeation issues in rectal absorption * Chemical means of enhancement * Carriers for enhanced delivery to and across the skin * Methods associated with breaching the skin * Promoted buccal and sublingual absorption * Emerging ocular, nasal, vaginal, and uterine delivery systems * Carriers for overcoming the blood brain barrier Those investigators primarily involved with one specific route of delivery will be able to learn of helpful concepts and find additional stimulat

Pharmaceutical Isothermal Calorimetry discusses the application of isothermal calorimetric techniques to challenges encountered during the rational design and development of novel drugs and drug delivery systems. Providing a comprehensive review of recent research and trends, this book contains an expert discussion of research and applications to pharmaceutical characterization and formulation.

Taking readers from the research laboratory to the bedside, this Second Edition compiles essential information on the pharmacodynamics of all major classes of the antimicrobial armamentarium including penicillins, cephalosposorins, cephamycins, carbapenems, monobactams, aminoglycosides, quinolones, macrolides, antifungals, antivirals, and emerging agents currently in development. Written by experienced professionals in the field, this guide uses an abundance of examples to depict methods to apply pharmacodynamic concepts to everyday clinical practice.

Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs and Drug Products, this text clarifies the guidelines set by the International Conference on Harmonization (ICH) and provides a comprehensive background in the scientific principles involved in photostability testing. Presenting the advantages and disadvantages of various procedures so the reader can select and utilize the most appropriate technique best-suited to their needs, this source includes references to current literature in the field and offers an opinion on future opportunities and challenges.

Employing a wide range of examples from G-protein-coupled receptors and ligand-gated ion channels, this detailed, single-source reference illustrates the principles of pharmacological analysis and receptor classification that are the basis of rational drug design. Explains the experimental and theoretical methods used to characterize interactions between ligands and receptors-providing the pharmacological information needed to solve treatment problems and facilitate the drug design process! Demonstrating the achievements of the receptor-based approach in therapeutics and indicating future directions, Receptor-Based Drug Design introduces novel computer-assisted strategies for the design of new agonists, antagonists, and inverse agonists for G-protein-coupled receptors shows how to assess agonist concentration-effect curve data discusses radioligand binding assays presents new in vitro multiarray assays for G-protein-coupled receptors explains the use of individual second messenger signaling responses in analyzing drug-receptor interactions examines the role of electrophysiology in finding new drugs and drug targets describes selectively acting b-adrenoceptor agonists and glucocorticoid steroids for asthma treatment outlines the rationale for using angiotensin receptor antagonists and more! Written by over 25 international authorities and containing nearly 1200 bibliographic citations, Receptor-Based Drug Design is a practical resource for pharmacologists, pharmacists, and pharmaceutical scientists; organic and medicinal chemists and biochemists; molecular biologists; biomedical researchers; and upper-level undergraduate and graduate students in these disciplines.

This authoritative guide will serve as the most current source on the design and manufacturing of parenteral dispersed systems-showcasing the utility of dispersed systems in drug delivery, drug targeting, and pharmaceutical engineering.

A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. Write it Down: Guidance for Preparing Effective and Compliant Documentation provides you with the tools you need to put effective documentation in place. The book has a three-pronged focus: to help writers understand the why of what they must write and the current industry standards for good documentation practices, to provide effective examples of a broad spectrum of documents, and to supply an in-depth explanation of grammar and punctuation conventions. Substantially expanded, the second edition focuses on the regulations, the need to document, and the range of documentation that must be in place to support therapeutic products from discovery through market. Readers will find useful examples of good writing, many provided by people in the industry. Letters and memos; short reports of varied topics, including equipment evaluation, vendor audit, and trip review; standard operating procedures, laboratory methods, and training materials; documentation for an IQ/OQ/PQ project; a journal article; and excerpts from a development report and a dossier are among the many examples. The book also gives a thorough explanation of grammar, punctuation, and usage, with a strong emphasis on the components of the language that pose difficulties for non-native writers of English. This book is a must for people working in or preparing to work in environments that produce drugs, medical devices, or biologics for sale in countries that have stringent regulatory requirements and where the business language is English. Firmly placing the writing task in context of the existing laws and guidances, the book offers valuable insights into managing systems and producing documentation that meets the requirements of the binding regulations.

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

This book reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients in the United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment. Examines excipients as a unique class of products and explores new procedures for determining toxicity! A timely and unique addition to the pharmaceutical literature, containing over 570 citations that support and enhance the text, Excipient Toxicity and Safety identifies the differences between excipients (inactive ingredients), food ingredients, and drug products evaluates issues of dose administration, species selection, and study design for various routes of exposure provides detailed information on the historical uses of excipients in drug formulations clarifies the Safety Committee of the International Pharmaceutical Excipients Council's (IPEC) guidelines and technical specifications for conducting tests for each route of exposure explains how data generated in toxicity models are applied to identify hazards in drug formulations details exposure assessment to link hazard identification with risk considers the requirements and importance of purity specifications and much more! Excipient Toxicity and Safety is a blue-ribbon reference ideal for pharmacists; toxicologists; pharmacologists; analytical chemists; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.

This definitive reference explores the various aspects of multiparticulate dosage form development-assessing the in vivo behavior and performance of multiparticulates as well as comparing their market position to other dosage forms. Discussing-for the first time in a comprehensive manner-alternative pelletization techniques such as balling (spherical agglomeration), spray congealing, and cryopelletization, Multiparticulate Oral Drug Delivery describes formulation and processing variables that affect the formation, integrity, and performance of coatings derived from molten materials and polymeric solutions and dispersions analyzes the biopharmaceutical aspects and in vivo performance of multiparticulate drug delivery systems details the idiosyncrasies of the manufacturing process of hard-shell gelatin capsules explains the different kinds of packaging materials and machinery and the importance of packaging during the development phase and beyond previews the marketing considerations of multiparticulate systems in the years to come presents practical solutions to problems encountered in the area of film-coating processes and more!

Once the existence of free radicals was proven, an avalanche of studies on free radical-mediated biological processes ensued. The study of reactive oxygen and nitrogen species (ROS and RNS) is center stage in biological free radical investigations. Written by a biochemist, Signaling Mechanisms of Oxygen and Nitrogen Free Radicals discusses the regulatory functions of ROS and RNS in physiological and pathophysiological states. An exploration of the main questions of signaling mechanisms of reactive oxygen and nitrogen species in enzymatic processes, this book draws attention to the chemical mechanisms of these reactions. It elucidates the differences between signaling functions and damaging effects of ROS and RNS in biological systems. The text also covers free radical signaling processes catalyzed by enzymes, producers of superoxide and nitric oxide that are able to use produced ROS and RNS as signaling species in their own catalytic processes. It then examines ROS and RNS signaling produced by mitochondrial enzymes. The author explores signaling functions of ROS and RNS in enzymatic heterolytic reactions, supplying important data on ROS and RNS signaling in the catalysis by the enzymes which do not produce free radicals by themselves. He provides information on signaling by reactive oxygen and nitrogen species in apoptosis and aging/senescence and concludes with coverage of mechanisms of free radical signaling in enzymatic processes. The book provides new understanding of signaling functions in living organisms related to cardiovascular processes, cancer, inflammation, hereditary diseases, and their regulation of physiological functions such as development, aging, and senescence. This information can support the development of new drugs and novel treatment methods.

Biopharmaceuticals, the term for genetically engineered therapeutic proteins, monoclonal antibodies, and nucleic acid-based products, have become an increasing part of the pharmaceutical armament. While this category of drugs accounts for approximately 25% of all new drugs coming to market, very few references exist that review these commercially available products. Until now, accessing data on the list of currently approved biopharmaceuticals has been laborious and patchy. Directory of Approved Biopharmaceutical Products brings together key information on various aspects of these compounds, presenting a brief summary of each biopharmaceutical currently approved for medical use. Each summary includes the scientific and trade name, year and regions approved, approved indications, manufacturer, marketing right, method of manufacture, scientific overview, and therapeutic properties. Based on information gathered from regulatory agencies and pharmaceutical manufacturers, the book presents the most comprehensive data currently available in a single, convenient volume. This comprehensive and consistent approach will save professionals in the pharmaceutical industry hours spent trawling the literature - and provides a singular resource for future reference.

Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Coverage include statistical techniques for assay validation and evaluation of drug performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines, basic considerations for the design and analysis of therapeutic equivalence and noninferiority trials.

Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical examples, database formats, standard operating procedures, work instructions, protocols, and reports. He gives readers the tools they need to develop an effective and manageable program that will not only be acceptable to both US and non-US regulatory authorities but will conserve an organization's time, money, and people resources.

This guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits. Includes the rationale for auditing as an important quality tool, along with the audit cycle, broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools will help you prepare checklists and standards so audits become more effective, consistent, and standardized. The book includes profiles of seasoned professionals in drug and device auditing, who share their experiences (the good and the bad)!

This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable

This practical book provides detailed guidance on all aspects of clean room airflow, the mechanics of airflow, and how microbial contamination is carried. Ljungqvist and Reinmuller draw on years of experience in clean room design and operation. The book contains maps of the effect of human interference on unidirectional airflow and the potential for contamination. Particle challenge test methods and tracer gas detection methods are explained, and the impact and interpretation of the results obtained from these test methods are discussed. Topics include: o Dispersion of Airborne Contaminants o Contamination Risks o Wakes (including factual situations) o Open, Unidirectional Air Flow Benches (laminar flow benches) o Microbiological Assessment o Weighing Stations o Air Flow Through Openings o Mathematical Treatment of Contamination Risks o Simulation of Air Flows & Dispersion of Contaminants through Doorways in a Suite of Clean Rooms o Regulatory Requirements

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.

Illustrates the use of systems such as in-process control, quality auditing, and specifications, stressing a troubleshooting, cost-effective approach to product packaging for maximized early lead time to the customer. Addressing the needs of the pharmaceutical industry, the approaches supplied are l

Novel Drug Delivery Systems for Phytoconstituents discusses general principles of drug targeting, construction material and technological concerns of different phytoconstituent in delivery systems. It focuses on the development of novel herbal formulations and summarizes their method of preparation, type of active ingredients, route of administration, biological activity and their applications. It dicusses therapeutic activities of plant derived chemicals, their limitations in clinical applications and novel drug delivery solutions to overcome them to provide better therapeutic effects with controlled and targeted drug delivery. Focus on drug delivery of phytomolecules Act as bridge between natural product scientist and clinical doctors Discusses mechanism of poor bioavailability of herbal molecules Increases awareness towards phytochemical efficacy Summarizes efficient novel delivery systems-based formulations. It extensively covers the applications of novel drug delivery systems including polymeric nanoparticles, solid lipid nanoparticles, nanostructured lipid capsules, liposomes, phytosomes, microsphere, transferosomes, and ethosomes. Some chapters are especially focused on anticancer phytodrugs, silymarin, andrographolide, berberine, and curcumin delivery with special emphasis on their application.

This invaluable resource discusses the current revolution in stem cell-based drugs and their potential use in clinical applications. Each chapter is contributed by a pre-eminent scientist in the field. An introductory section presents current stem cell drugs and stem cell-based products and a discussion of production, quality control, mechanisms, and efficacy. Following sections include discussions on stem cell-derived microvesicles based products, and derived exosomes based products. Stem Cell Drugs - A New Generation of Biopharmaceuticals and the other books in the Stem Cells in Clinical Applications series are invaluable to scientists, researchers, advanced students and clinicians working in stem cells, regenerative medicine or tissue engineering. This groundbreaking volume is also essential reading for those researching or studying drug development or pharmaceutical science.

This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the 'technology' focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors

Furthering efforts to simulate the potency and specificity exhibited by peptides and proteins in healthy cells, this remarkable reference supplies pharmaceutical scientists with a wealth of techniques for tapping the enormous therapeutic potential of these molecules-providing a solid basis of knowledge for new drug design. Provides a broad, comprehensive overview of peptides and proteins as mediators of cell movement, proliferation, differentiation, and communication. Written by more than 50 leading international authorities, Peptides and Protein Drug Analysis discusses strategies for dealing with the complexity of peptides and proteins in conformational flexibility and amino acid sequence variability analyzes drug formulations facilitated by solid-phase peptide synthesis and recombinant DNA technology examines chemical purity analysis by high-pressure chromatographic, capillary electrophoretic, gel electrophoretic, and isoelectric focusing methods highlights drug design elements derived from protein folding, bioinformatics, and computational chemistry demonstrates uses of unnatural mutagenesis and combinatorial chemistry explores mass spectrometry, protein sequence, and carbohydrate analysis illustrates bioassays and other new functional analysis methods surveys spectroscopic techniques such as ultraviolet, fluorescence, Fourier transform infrared, and nuclear magnetic resonance (NMR) addresses ways of distinguishing between levels of therapeutic and endogenous agents in cells reviews structural analysis tools such as ultracentrifugation and light, X-ray, and neutron scattering and more! Featuring over 3400 bibliographic citations and more than 500 tables, equations, and illustrations, Peptide and Protein Drug Analysis is a must-read resource for pharmacists; pharmacologists; analytical, organic, and pharmaceutical chemis

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 Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards