This volume contains the proceedings of the Eighth International Symposium on Cyclodextrins, held in Budapest, Hungary, March 31-April 2, 1996. The 147 papers collected here are milestones in the exponentially increasing cyclodextrin literature, and represent a summary of the last two years' achievement in this field, with applications in such diverse disciplines as pharmaceuticals, food, cosmetics, textiles, plastics, and chromatography. Some highlights: lipophilicity profiles of cyclodextrins by computer molecular graphics; recent toxicological studies on cyclodextrins; Buckminsterfullerene/cyclodextrin complexes; hydroxypropyl-beta-cyclodextrin; pharmacokinetics and toxicology; peracylated cyclodextrins as drug carriers; cyclodextrins in nasal drug delivery; textile fibre surface modification by a reactive cyclodextrin; cyclodextrin-containing fabric care products; drug targeting by cyclodextrin-dimers for photodynamic cancer therapy; cyclodextrins in ophthalmologic drugs; new cyclodextrin derivatives and their potentials. Audience: This book will be of interest to researchers whose work involves pharmaceuticals, food chemicals and flavours, food additives, chromatographic methods, and biotechnology, as well as fundamental cyclodextrin research.

The first book in the newly created book series, Computer-Aided Drug Discovery and Design, focuses on the computational aspects of early drug discovery, drug target identification, and validation. It revises current classical paradigms in target and phenotypic-based drug design with still ingrained approximations and concepts and discusses the research in the new network approach concept that include kinetic selectivity and metabolic analysis. Many often-overlooked approximations and concepts in drug discovery are fully covered. Drug Target Selection and Validation includes both introductory sections and research-based sections to be of use to both students and research scientists in drug discovery, design, kinetics and metabolic analysis. Pharmaceutical scientists, pharmaceutics, drug developers, pharmacologists, biomedical researchers in computer science, medicinal chemists, and precision medicine developers benefit from the information provided. The book concludes with a chapter on chemical and structural databases.

Updated and revised throughout. Second Edition explores the chromatographic methods used for the measurement of drugs, impurities, and excipients in pharmaceutical preparations--such as tablets, ointments, and injectables. Contains a 148-page table listing the chromatographic data of over 1300 drugs and related substances--including sample matrix analyzed, sample handling procedures, column packings, mobile phase, mode of detection, and more.

This book critically investigates the patent protection of medication in light of the threats posed by HIV/AIDS, malaria and tuberculosis epidemics to the citizens of countries in Sub-Saharan Africa (hereinafter "SSA" or "Africa"). The book outlines the systemic problems associated with the prevailing globalized patent regime and the regime's inability to promote access to life-saving medication at affordable prices in SSA. It argues that for pharmaceutical patents to retain their relevance in SSA countries, human development concepts must be integrated into global patent law- and policy-making. An integrative approach implies developing additional public health and human development exceptions/limitations to the exercise of patent rights with the goal of scaling up access to medication that can treat epidemics in SSA. By drawing on multiple perspectives of laws, institutions, practices, and politics, the book suggests that SSA countries adopt an evidence-based approach to implementing global patent standards in domestic jurisdictions. This evidence-based approach would include mechanisms like local need assessments and the use of empirical data to shape domestic patent law-making endeavors. The approach also implies revising patent rules and policies with a pro-poor and pro-health emphasis, so that medication will be more affordable and accessible to the citizens of SSA countries. It also suggests considering the opinions of individuals and pro-access institutions in enacting crucial pieces of health-related statutes in SSA countries. The approach in this book is sensitive to the public health needs of the citizens affected by epidemics and to the imperative of building local manufacturing facilities for pharmaceutical research and development in SSA.

Stressing the theory involved in formulating suspensions, emulsions, and colloidal drug products, this Second Edition of a well-received reference test highlights typical formulations, the avoidance of formulation pitfalls, and compliance with established regulatory principles.

This volume of Pharmaceutical Biocatalysis starts with a discussion on the importance of biocatalytic synthesis approaches for a sustainable and environmentally friendly production of pharmaceuticals and active pharmaceutical ingredients. Among the enzymes discussed in detail with respect to their pharmaceutical relevance are cyclic nucleotide phosphodiesterases playing an important role in modulating signal transduction in various cell types; human DOPA decarboxylase, related to Parkinson's disease and aromatic amino acid decarboxylase deficiency; and phospholipase D enzymes as drug targets. Isocitrate dehydrogenase 1 and 2 mutations are novel therapeutic targets in acute myeloid leukemia. An additional chapter is devoted to the use of enzymes for prodrug activation in cancer therapy. The other topics include small-molecule inhibitors targeting receptor tyrosine kinases in cancer, -Lactams and related compounds as antibacterials, non-vitamin K oral anticoagulants for the treatment of thromboembolic diseases, and the molecular mechanisms for statin pleiotropy and its clinical relevance in cardiovascular diseases. The last chapter is a review of lysosomal storage disorders with an overview of approved drugs for treating these disorders by enzyme replacement therapy.

An established textbook that provides you with full coverage of the physicochemical principles essential to the modern pharmacist and pharmaceutical scientist. This sixth edition has a broad chemical and physicochemical base and covers every aspect of drug properties from the design of dosage forms to their delivery by all routes to sites of action in the body. Now with more clinical examples, new questions and extra case studies.

A reference is needed that addresses the recent progress in aspects of PK/PD methods and developments of nanoparticles for novel drug delivery systems. No other consolidated published reference discusses the PK/PD study of nanoparticle drug delivery systems. This book discusses the advantages of nanoparticle drug delivery systems (NPDDS) in enhancing the pharmacokinetics of many drugs that are not easily metabolized or that obtain the desired therapeutic effect with minimum toxicity. The authors provide an overview of biodistribution with a focus on polymer and lipid nanoparticles. This thorough reference is divided into three parts: Modelling, Specific carries and their potential to treat specific diseases.

Honey typically has a complex chemical and biochemical composition that invariably includes complex sugars, specific proteins, amino acids, phenols, vitamins, and rare minerals. It is reported to be beneficial in the treatment of various diseases, such as those affecting the respiratory, cardiovascular, gastrointestinal, and nervous systems, as well as diabetes mellitus and certain types of cancers; however, there is limited literature describing the use of honey in modern medicine. This book provides evidence-based information on the pharmaceutical potential of honey along with its therapeutic applications and precise mechanisms of action. It discusses in detail the phytochemistry and pharmacological properties of honey, highlighting the economic and culturally significant medicinal uses of honey and comprehensively reviewing the scientific research on the traditional uses, chemical composition, scientific validation, and general pharmacognostical characteristics. Given its scope, it is a valuable tool for researchers and scientists interested in drug discovery and the chemistry and pharmacology of honey.

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

This volume provides information on how to select and screen plants for their medicinal properties. It describes phytopharmacological techniques for extracting and qualitatively and quantitatively analyzing a plant's phytochemicals. After a detailed in vitro investigation including nutritional and anti-nutritional analyses, medicinal properties were tested with various in vivo models for anti-inflammatory, analgesic, anti-pyretic, anticancer and anti-diabetic properties, as well as wound healing, neurodegenerative diseases, etc. Compound identification and purification techniques include, among others, TLC and column chromatography, as well as molecular docking with specific proteins.

This book provides an overview of the theories and applications on subgroups in the biopharmaceutical industry. Drawing from a range of expert perspectives in academia and industry, this collection offers an overarching dialogue about recent advances in biopharmaceutical applications, novel statistical and methodological developments, and potential future directions. The volume covers topics in subgroups in clinical trial design; subgroup identification and personalized medicine; and general issues in subgroup analyses, including regulatory ones. Included chapters present current methods, theories, and case applications in the diverse field of subgroup application and analysis. Offering timely perspectives from a range of authoritative sources, the volume is designed to have wide appeal to professionals in the pharmaceutical industry and to graduate students and researchers in academe and government.

Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.

From the Authors' Preface The advances made in the area of controlled drug delivery during the last two decades are remarkable ....Of the many polymeric materials, biodegradable hydrogels present unique advantages and opportunities in the development of ...delivery devices....We have undertaken the challenge of putting together information relevant to biodegradable hydrogels in one place. This book covers the mechanisms of biodegradation, types of biodegradable hydrogels,chemical and physical gels, chemical and enzymatic degradation, and examples of biodegradable drug delivery systems.

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

Introduction, Historical Highlights, and the Need for Dissolution Testing Theories of Dissolution Dissolution Testing Devices Automation in Dissolution Testing, by William A. Hanson and Albertha M. Paul Factors That Influence Dissolution Testing Interpretation of Dissolution Rate Data Techniques and of In Vivo Dissolution, by Umesh V. Banakar, Chetan D. Lathia, and John H. Wood Dissolution of Dosage Forms Dissolution of Modified-Release Dosage Forms Dissolution and Bioavailability Dissolution Testing and the Assessment of Bioavailability/Bioequivalence, by Santosh J. Vetticaden Dissolution Rediscovered, by John H. Wood Appendix: USP/NF Dissolution Test.

Proteins are still gaining importance in the pharmaceutical world, where they are used to improve our arsenal of therapeutic drugs and vaccines and as diagnostic tools. Proteins are different from "traditional" low-molecular-weight drugs. As a group, they exhibit a number of biopharmaceutical and formulation problems. These problems have drawn considerable interest from both industrial and aca demic environments, forcing pharmaceutical scientists to explore a domain previ ously examined only by peptide and protein chemists. Biopharmaceutical aspects of proteins, e.g., low oral bioavailability, have been extensively investigated. Although all possible conventional routes of ad ministration have been examined for proteins, no real, generally applicable alter native to parenteral administration in order to achieve systemic effects has yet been discovered. Several of these biopharmaceutical options have been discussed in Volume 4 of this series, Biological Barriers to Protein Delivery. Proteins are composed of many amino acids, several of which are notorious for their chemical instability. Rational design of formulations that optimize the native structure and/or bioactivity of a protein is therefore of great importance when long shelf life is required, as it is for pharmaceutical products. This issue has also been examined in two prior volumes of this series: Volume 2: Stability of Protein Pharmaceuticals (Part A) and Volume 5: Stability and Characterization of Protein and Peptide Drugs."

*Provides an overview of statistical and analytic methodologies in real-world evidence to generate insights on healthcare, with a special focus on the pharmaceutical industry *Examines timely topics of high relevance to industry such as bioethical considerations, regulatory standards and compliance requirements *Highlights emerging and current trends, and provides guidelines for best practices *Illustrates methods through examples and use-case studies to demonstrate impact *Provides guidance on software choices and digital applications for successful analytics.

This book addresses the issues relating to a wide variety of ocular diseases from which millions of people suffer. Long-term challenges include visual impairment and ocular blindness. Certain ocular diseases are quite rare, whereas others, such as cataracts, age-related macular degeneration (AMD), and glaucoma, are very common, especially in the aging population. A rapid expansion of new technologies in ocular drug delivery and new drug candidates, including biologics, to treat these challenging diseases in the retina and posterior segments of the eye have recently emerged. These approaches are necessary because the eye has many unique barriers to drug delivery. Thus, this timely reference Drug Delivery for the Retina and Posterior Segment Disease compiles and analyzes recent advances in the research and development of drug delivery systems for retina and posterior segment diseases of the eye, with an emphasis on the use of implantable devices, iontophoresis as well as micro- and nanoparticles.

• Describes the endemic plants used in traditional medicine • Includes the chemical and bioactive compounds from desertic medicinal plants • Addresses the analytic techniques to determine chemical and bioactive compounds • Represents an effort to keep the ethnobiological knowledge of communities

This book provides the pharmaceutical formulator with the fundamental understanding necessary to prepare efficacious topical drug delivery formulations that have both chemical and physical stability and that are cosmetically acceptable and preferably cosmetically elegant.

Essentials of Industrial Pharmacy is an attempt to comprehensively present, in a single book, various pharmaceutical processes and equipment that are frequently used for production of pharmaceutical dosage forms, along with quality control tests of these dosage forms. Pictorial/graphical illustrations provide easier understanding of complex pharmaceutical concepts, manufacturing processes of pharmaceutical dosage forms. Since it is imperative for pharmacy students to have a clear understanding of the basic concepts used in development of drugs into suitable and stable dosage forms. This book offers a wealth of information regarding basic aspects of pharmaceutical processes and dosage forms, in a single book, for undergraduate pharmacy students or science students (with no pharmacy background) intended to work in the pharmaceutical Industry.

The Art and Science of Dermal Formulation Development is a comprehensive guide to the theory and practice of transdermal and topical formulation development, covering preclinical studies, evaluation, and regulatory approval. It enables the reader to understand the opportunities and challenges in developing products and how risks can be mitigated. Over the last 25 years, expertise in this area has declined whilst drug delivery systems for other administration routes have developed significantly. The advantages offered by transdermal and topical drug delivery remain compelling for sectors including the pharmaceutical industry, personal care, and cosmetics. This text addresses the dearth of expertise and discusses how skin can be a route of delivery and the processes in formulation development, but how such an application is very different to that used for oral, IV, and other administration routes. Key Features: Presents a practical guide for both industry and academia Focuses on and draws together the fundamental principles behind transdermal and topical drug delivery Illustrates the practicalities of formulation design using key case studies Gives an understanding of the skin as a route of delivery and how formulation development for such application differs from that for other administration routes

This book offers an authoritative review of biopharmaceuticals and their clinical relevance. Biopharmaceuticals have been showing high therapeutic potential by means of biological and biosimilar medicines, particularly for the treatment of cancer, chronic diseases (e.g. diabetes, Crohn's disease, psoriasis and rheumatoid arthritis), neurodegenerative disorders (e.g. multiple sclerosis), and they have also been contributing to the progress of innovative therapies such as assisted reproductive medicine. Since the eighties, several biopharmaceuticals have been approved and, due to patents expiration, many biosimilars are also marketed. In this book, readers will find the most relevant updated information about the main clinical applications of pharmaceutical biotechnology. The authors provide expert analysis about the industrial challenges of recombinant proteins and the different classes of biopharmaceuticals, including monoclonal antibodies, vaccines, growth factors and stem cells. Topics such as bioprinting technologies in tissue engineering, gene therapy and personalized medicine are also covered in this book. Professionals, students and researchers interested in this field will find this work an important account.

Overview of the development of gene therapy Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing Presents CRISPR gene therapy recent trends and applications Discusses siRNA, mRNA, and DNA plasmids