Conceived and edited by Nigel Dent and Ramzan Visanji, Veterinary Clinical Trials form Concept to Completion is designed for both established practitioners and novices, offering alternative ways of conducting studies and ensuring that the studies are guided by Good Clinical Practices and are in compliance with regulations. Comprehensive in scope, it provides the scientific, biological, and regulatory background invaluable to teachers, researchers, and regulatory affairs staff, as well as those directly involved in clinical trials. The book covers: -Objectives of the clinical study -Control of the study -Conduct of the study -Regulation versus compliance -Factors for success -International harmonization activities -Roles of the investigator, the monitor, and the practicing veterinarian -Setting up GCP trials with particular animal species -SOPs, the generic protocol, and the study report -Contract research farms and multi-site studies -Auditing With contributions from experts in every area of veterinary trials, the text has been organized with everyday use in mind. The chapters can be read sequentially for a comprehensive view or individually for coverage of particular topics and issues as needed. Drawing directly from the in-the-trenches experience of the editors and chapter authors, the book is a guide to methods that ensure studies meet regulatory compliance and strategies that ensure avoidance of common pitfalls.

Acacias: The Genus Acacia (sensu lato) is an evidence-based treatment of this super genus, through the eyes of a clinical pharmacognosist and integrative medicine specialist. The book begins with antiviral activity, revealing within the five genera of Acacia s.l., pharmacological properties and pharmacologically active compounds. Profiles of prominent species within these genera, including photographs, accompany the narrative of current research and traditional usage into antibacterial, antifungal, anticancer, antidiabetic, metabolic syndrome ameliorative, and psychotherapeutic potential. Features: Comprehensive treatment of the entire Acacia sensu lato genus. Aids ethnopharmacological prospectors of new sources of novel botanically-based medicines for modern metabolic and psychiatric diseases. Illuminates the presence of psychedelic simple substituted tryptamines in trees and their medical and psychotherapeutic potential. Acacias: The Genus Acacia (sensu lato) provides a unique and comprehensive coverage of one of the most interesting and diverse genera of trees, firmly entrenched in the Levant, Africa, Australia, the Far East, and the New World. The influence of these genera on pharmacy and industry (especially through gum arabic, wildcrafted in Africa from Senigallia senigallia), human consciousness, the advent and development of religions, planetary ecology, botanical therapeutics, and the emergence of psychedelic medicine reflects both the history of our species and the transformative promise of tomorrow.

Demonstrates how substitution of a variety of ligands can render albumin a versatile targeting tool for selective drug accumulation in various cell populations of the liver
This book discusses physical, chemical, and biological approaches to drug targeting technology, focusing on oral, dispersed system, topical, dermal, transdermal, and inhalation delivery, and the development of original formulations that are matched by innovative device design.
Considers the efforts in biotechnology and molecular biology to produce intelligent drug delivery devices by exploiting biological pathways
Containing over 1100 references to facilitate further study, Drug Targeting Technology
updates recent progress in oral and colonic targeting technology using pH- and enzyme-sensitive coating materials and novel polymer systems
shows how the systemic distribution of drugs can be modulated by lipid-based carriers taking alternative routes of transport, particularly lymph flow
details soft drugs that are rapidly metabolized to inactive and nontoxic metabolites and removed efficiently from the body
includes successful designs of virus-like liposomal delivery systems that offer the advantages of viral carriers
supplies examples of how viral delivery systems can be directed to cancer sites
and more
Suggesting harnessing biological processes as the ultimate approach to the delivery or expression of pharmacologically active agents, Drug Targeting Technology is a top-shelf reference for pharmacists, pharmacologists, and pharmaceutical scientists; analytical, surface, physical, and colloid chemists and biochemists; and upper-level undergraduate and graduate students in these disciplines.

Instant Notes in Medicinal Chemistry provides concise coverage for undergraduates studying medicinal chemistry as part of a science, pharmacy or medical course. It is a truly multidisciplinary subject involving such subject specialities as organic chemistry, pharmacology, biochemistry, physiology, microbiology, toxicology, genetics and computer modeling. It concentrates on the fundamental principles of medicinal chemistry and assumes no more than elementary background of chemistry or biology.

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.

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 chemists; cell and molecular biologists; biochemists; 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.

This comprehensive text presents a rigorous framework from within which regulators can respond strategically to the claim by the pharmaceutical industry that lower drug prices today lead to a loss for the population's future health due to less innovation. It starts with a critical review of the empirical evidence of the return to consumers on their ongoing investment into high drug prices in order to increase future innovation. The implicit, critical and unrealistic assumption inherent in these studies is identified, namely that the health budget can be expanded to purchase drugs at higher prices without an opportunity cost, for example, the foregone benefits of alternative investments in health care infrastructure. Price effectiveness analysis (PEA), is introduced. PEA informs the question of how the innovative surplus from the new drug should be allocated between the manufacturer and the consumer so as to optimise society's welfare. The method allows the decisions by the regulator and the firm to be analysed jointly by specifying the firm's production and revenue functions in terms of the clinical innovation of a new drug; the incremental effect used in the summary metric of cost effectiveness analysis. An economic value of innovation that takes into account opportunity cost under conditions of economic efficiency in the health system is proposed: the health shadow price. The limitations of the non-strategic methods that currently inform the highly contested new drug subsidy game are presented and the relative strengths of PEA are demonstrated. Health technology assessment quantifies both the clinical innovation of a new drug and its financial impact on the health system. Cost effectiveness analysis tests the relationship between the incremental cost and incremental effect of a new drug for target patients, at a given price. PEA tests the relationship between the price of a new drug and the health of the whole population, now and into the future. It achieves this by taking into account current inefficiency in both resource allocation and the displacement process, and the relationship between price and future innovation.

There is no current book is available in the market explaining medicinal values, toxicity responses, and other potential uses of poisonous plants exclusively. In recent years, extensive attention has been paid towards the up-gradation of medicinal and herbal plants therefore; this book includes important chapters on relevant topics. Audience - Those who are working on or have an interest in modern research especially in medicinal, herbal, and poisonous plants and is also useful for some pharmaceutical companies involved in herbal drug preparation.

Suppliers of pharmaceutical manufacturing equipment must ensure that their equipment is provided to their customers in a validatable state. Written in simple, clear, and concise language that gets past all the regulationese, this book covers the basics of validation, planning process equipment design and construction, documentation requirements, avoiding validation pitfalls, and the types of services the supplier should provide. The book provides insights on how to avoid the costly and time-consuming problem of reworking the equipment to develop the information that is needed to successfully complete their validation package - after the equipment has been delivered and installed. Here in one volume is all the information suppliers and manufacturers need to be able to effectively conduct business in a cost- and time-effective manner. Key areas of discussion include: o Validation and GMP issues o Why validation is so important to pharmaceutical manufacturers o The role of equipment suppliers in supporting validation o How validation affects the quality of drugs o A discussion of the importance of each phase of validation o Examples of pre-validation work o Pharmaceutical industry conventions for equipment design & construction o Questions to ask about validation, including a checklist o Regulations in plain language, including the terms and vocabulary o Computer validation o Business & cost issues

Key Features: 1. Describes the development of the randomized, controlled trial as the gold standard of proof. 2. Unravels the meaning of "randomized," "double-blind" and "p-values" in a simplified manner for students and clinicians. 3. Contains timeless information on how medical evidence can be understood.

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 DesignA* offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other booksA* reviews screening designs for qualitative factors at different levelsA* presents designs for predictive models and their use in optimizationA* highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirabilityA* discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transferA* details nonstandard designs and mixturesA* analyzes factorial, D-optimal design, and offline quality assurance techniquesA* reveals how one experimental design evolves from anotherA* 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.

Key Points: 1. Discusses the role of microbial enzymes in functional food and nutraceutical production 2. Covers a range of enzymes like proteases, pullulanases, lipases 3. Explores various microbial sourcess and processing techniques 4. Reviews application of enzymes in synthesis of chiral drug intermediates 5. Examines molecular techniques on improving microbial enzymes properties and ability

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 for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.

This incomparable Second Edition of a highly regarded reference has been entirely rewritten and enlarged to reflect the explosion of information and technologies that have emerged since the publication of the previous edition.
Strikes the perfect balance between proven traditional approaches and modern methods that promise to yield new products and processes
Specifically addressing microbially derived commercially important bioactive products that are currently or soon-to-be available, Biotechnology of Antibiotics, Second Edition
analyzes the use of recombinant enzymes to produce biologically active molecules, including a cholesterol-lowering agent, an anti-HIV drug for the treatment of AIDS, and b-lactam antibiotics
gives insight into the biochemistry, molecular biology, and production of antibiotics used as therapeutic agents
focuses on state-of-the-art techniques for the development of new antibiotics using novel approaches and strategies
highlights recent advances in the genetic manipulation of antibiotic biosynthesis genes to create structures from gene combinations for new biological activities
describes in detail the development and current status of newly created antibiotics and pharmacologically active natural products
and much more
Written by authorities from both industry and academia and containing nearly 4000 bibliographic citations, Biotechnology of Antibiotics, Second Edition is an outstanding resource for pharmaceutical scientists, medicinal chemists and biochemists, molecular biologists and industrial microbiologists, chemical engineers, fermentation bioengineers, bioprocess technologists, and upper-level undergraduate and graduate students in these disciplines.

It gives me immense pleasure to present a book entitled "Quality assurance techniques in pharmaceuticals". Need to write this book is ever increasing the data on the subject matter of quality assurance. In the era of quality assurance, every firm need to be quality assured so that it can achieve its quality goal. Book is prepared to emphasis on the basic techniques, methods, plans, certification procedures for quality assurance, keeping in mind the syllabus of quality assurance techniques laid by various Indian universities. Goal of this book is to provide primary and update knowledge of various quality assurance data to master of pharmacy students in the professional programme of their study. The on statistical methods used for method development is prepared by keeping in mind the need of method development for various drug combinations. Special emphasis is given on modern techniques like SUPAC and PAT. Beside these ISO,GMP,ICH Guidelines are very well explained.

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

Social and Behavioral Aspects of Pharmaceutical Care takes known social and behavioral science principles and applies them to pharmacy practice. This allows readers who are training to deliver or already delivering pharmaceutical care to enhance their communication, counseling, and patient education skills. While working through this superb text, students and practitioners will develop optimal skills as problemsolvers, therapeutic consultants, patient educators, and counselors as they learn how to enhance patient compliance, negate stigma, and help patients become more comfortable with their medical situations. The instructor's manual that comes with the text is filled with exercises that highlight the most important aspects of each chapter and engages readers in the content of each chapter. Readers who approach this text with a real desire to better understand how behavior links to the complexities of an individual's or social group's actions and deeds will find it exhilarating reading as they gain a better understanding of and appreciation for pharmaceutical care and its behavioral underpinnings.Also, instead of offering only a few definitive answers, Social and Behavioral Aspects of Pharmaceutical Care contains extensive descriptions of phenomena known to be true but which are all subject to change when new variables are introduced. This helps readers become more aware of and comfortable with the gray areas of pharmacy. Authors in Social and Behavioral Aspects of Pharmaceutical Care take pieces of the complex web of pharmaceutical care, describe known microcosmic components of such care, and then relate the pieces back to the integrity of the web. Readers will find that the behavior of the patient, the prescriber, the systems that allow for these interactions, and, ultimately, the outcomes of medication use are in fact, not as simple as they may appear.Readers learn to deal with these complexities by improving their interactive skills in these areas: compliance placebosmedication stigma self-medicationhealth beliefs opinion informationprofessionalism socializationnonmedical drug use public healthillness behavior sick rolehow attitudes affect behaviorsethics Using this text in pharmaceutical administration, social pharmacy, and behavioral pharmacy courses better prepares training pharmacists for contemporary and future roles that more closely bind them to their patients and their prescribing community. It offers an excellent, comprehensive overview of the social-economic aspect of pharmaceutical care through its theoretical models and practical examples that elaborate on the pharmacist's role in identifying patients'non-compliant behavior and in managing other drug-related problems.Undergraduate and graduate pharmacy students; pharmacy school, drug company, and health science center libraries; practicing retail and hospital pharmacists; and national, state, and local pharmacy associations will find Social and Behavioral Aspects of Pharmaceutical Care an important addition to their reading material as it serves as a valuable developmental tool for both students and practicing professionals

This book examines death rituals and the social significance of undertaking in western society and presents an ethnographic account of funeral directing in an area of east London which, for the purposes of anonymity. It is concerned with undertakers' perceptions and organization of death rituals.

A reference on drug metabolism and metabolite safety in the development phase, this book reviews the analytical techniques and experimental designs critical for metabolite studies. It features case studies of lessons learned and real world examples, along with regulatory perspectives from the US FDA and EMA. Reviews the analytical techniques and experimental designs critical for metabolite studies Covers methods including chirality, species differences, mass spectrometry, radiolabels, and in vitro / in vivo correlation Discusses target pharmacology, in vitro systems aligned to toxicity tests, and drug-drug interactions Includes perspectives from authors with firsthand involvement in industry and the study of drug metabolites, including viewpoints that have influenced regulatory guidelines

This book is a comprehensive compilation of modern and cutting-edge chromatographic techniques written by pharmaceutical industry experts, academics, and vendors in the field. This book is an inclusive guide to developing all chromatographic methods (such as liquid chromatography and gas chromatography). It covers modern techniques for developing methods using chromatographic development software, requirements for validations, discussion on orthogonality, and how to transfer methods from HPLC to UHPLC. The text introduces some newer techniques that are heavily employed by chemists analyzing proteins and RNAi, as well as novel techniques such as counter current chromatography. This book is valuable for both the novice starting out in undergraduate labs and those who are new to the pharmaceutical industry and is a useful reference for seasoned analysts.

Vol. 2 of Chemoinformatics of Natural Products introduces the reader to the currently available tools for toxicity prediction, drug property prediction, an enumeration of compounds, scaffolds and functional groups in nature, computational methods for lead identification, metabolite biosynthesis, etc. Selected case studies and hands-on tutorial exercises have been included.

The definitive guide to the myriad analytical techniques available to scientists involved in biotherapeutics research Analytical Characterization of Biotherapeutics covers all current and emerging analytical tools and techniques used for the characterization of therapeutic proteins and antigen reagents. From basic recombinant antigen and antibody characterization, to complex analyses for increasingly complex molecular designs, the book explores the history of the analysis techniques and offers valuable insights into the most important emerging analytical solutions. In addition, it frames critical questions warranting attention in the design and delivery of a therapeutic protein, exposes analytical challenges that may occur when characterizing these molecules, and presents a number of tested solutions. The first single-volume guide of its kind, Analytical Characterization of Biotherapeutics brings together contributions from scientists at the leading edge of biotherapeutics research and manufacturing. Key topics covered in-depth include the structural characterization of recombinant proteins and antibodies, antibody de novo sequencing, characterization of antibody drug conjugates, characterization of bi-specific or other hybrid molecules, characterization of manufacturing host-cell contaminant proteins, analytical tools for biologics molecular assessment, and more. * Each chapter is written by a recognized expert or experts in their field who discuss current and cutting edge approaches to fully characterizing biotherapeutic proteins and antigen reagents * Covers the full range of characterization strategies for large molecule based therapeutics * Provides an up-to-date account of the latest approaches used for large molecule characterization * Chapters cover the background needed to understand the challenges at hand, solutions to characterize these large molecules, and a summary of emerging options for analytical characterization Analytical Characterization of Biotherapeutics is an up-to-date resource for analytical scientists, biologists, and mass spectrometrists involved in the analysis of biomolecules, as well as scientists employed in the pharmaceuticals and biotechnology industries. Graduate students in biology and analytical science, and their instructors will find it to be fascinating and instructive supplementary reading.

Of the thousands of novel compounds that a drug discovery project team invents and that bind to the therapeutic target, only a fraction have sufficient ADME (absorption, distribution, metabolism, elimination) properties, and acceptable toxicology properties, to become a drug product that will successfully complete human Phase I clinical trials. Drug-Like Properties: Concepts, Structure Design and Methods from ADME to Toxicity Optimization, Second Edition, provides scientists and students the background and tools to understand, discover, and develop optimal clinical candidates. This valuable resource explores physiochemical properties, including solubility and permeability, before exploring how compounds are absorbed, distributed, and metabolized safely and stably. Review chapters provide context and underscore the importance of key concepts such as pharmacokinetics, toxicity, the blood-brain barrier, diagnosing drug limitations, prodrugs, and formulation. Building on those foundations, this thoroughly updated revision covers a wide variety of current methods for the screening (high throughput), diagnosis (medium throughput) and in-depth (low throughput) analysis of drug properties for process and product improvement. From conducting key assays for interpretation and structural analysis, the reader learns to implement modification methods and improve each ADME property. Through valuable case studies, structure-property relationship descriptions, and structure modification strategies, Drug-Like Properties, Second Edition, offers tools and methods for ADME/Tox scientists through all aspects of drug research, discovery, design, development, and optimization.

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.