Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation practices. The book discusses how to clinical trial designs according to their probability for success, techniques to define distributions of virtual subjects' characteristics, methods to determine the sensitivity of the trial design, and the population relationship between dosing schedules and patient response.

As our understanding of the science and functions of color in food has increased, the preferred colorants, forms of use, and legislation regulating their uses have also changed. Natural Colorants for Food and Nutraceutical Uses reflects the current tendency to use natural pigments. It details their science, technology, and applications as well as their nutraceutical properties.

Starting with the basics, the book creates an understanding of physical colors, discusses color measurement, and analyzes why natural pigments are preferred today. The authors present an overview of global colorants, including safety, toxicity and regulatory aspects. Information about inorganic and synthetic colorants is included. The book then focuses on applications of natural colorants, with special attention given to characteristics, extraction and processing stability, and the use of biotechnology and molecular biology to increase colorant production. Finally, the book examines the nutraceutical properties of natural colorants and compares them to other well-known nutraceutical components.

From the basics to highly specialized concepts and applications, Natural Colorants for Food and Nutraceutical Uses presents essential, practical information about pigments in the food industry. With its coverage of state-of-the-art technologies and future trends in the application of color to food, this book provides the most comprehensive, up-to-date survey of the field.

Bioreactors: Animal Cell Culture Control for Bioprocess Engineering presents the design, fabrication, and control of a new type of bioreactor meant especially for animal cell line culture. The new bioreactor, called the "see-saw bioreactor," is ideal for the growth of cells with a sensitive membrane. The see-saw bioreactor derives its name from its principle of operation in which liquid columns in either limb of the reactor alternately go up and down. The working volume of the reactor is small, to within 15 L. However, it can easily be scaled up for large production in volume of cell mass in the drug and pharmaceutical industries. The authors describe the principle of operation of the see-saw bioreactor and how to automatically control the bioprocess. They discuss different control strategies as well as the thorough experimental research they conducted on this prototype bioreactor in which they applied a time delay control for yield maximization. To give you a complete understanding of the design and development of the see-saw bioreactor, the authors cover the mathematical model they use to describe the kinetics of fermentation, the genetic algorithms used for deriving the optimal time trajectories of the bioprocess variables, and the corresponding control inputs for maximizing the product yield. One chapter is devoted to the application of time delay control. Following a description of the bioreactor's working setup in the laboratory, the authors sum up their investigation and define the future scope of work in terms of design, control, and software sensors.

This book is devoted to a broader understanding of liposomes as a versatile tool used in many domains, including basic research and applied technology, focusing on less common applications and recent developments. Over the past few years, new types of liposomes made of nonphospholipid molecules have opened new perspectives in applications. These lipid vesicles, already used in cosmetology, are being manufactured for industrial and agricultural uses. However, "Stealth" liposomes, pH-sensitive liposomes, and cationic liposomes have enlarged and improved the application field of liposomes in clinical research. The book covers these different uses of liposomes with particular attention to new formulations and new applications.

Key features: The most comprehensive resource available on the biodiversity of algal species, their industrial production processes and their use for human consumption in food, health and varied applications. Emphasis on basic and applied research, addressing aspects of scale-up for commercial exploitation for the development of novel phytochemicals (phytochemicals from algae). Addresses the underexplored and underutilized potential of chemicals from marine sources for health benefits. Each chapter, written by expert contributors from around the world, includes Summary Points, Figures and Tables, as well as up-to-date references. The first book in this two-volume set explores the diversity of algal constituents for health and disease applications. The commercial value of chemicals of value to food and health is about $6 billion annually, of which 30 percent relates to micro and macro algal metabolites and products for health food applications. This comprenhensive volume looks in detail at algal genomics and metabolomics as well as mass production of microalgae. As a whole, the two-volume set covers all micro and macro algal forms and their traditional uses; their constituents which are of value for food, feed, specialty chemicals, bioactive compounds for novel applications, and bioenergy molecules. Bio-business and the market share of algae-based products are also dealt with, providing global perspectives.

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 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

Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors' experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.

Biotechnology represents a novel and expanding international industry bound by new and ever-changing legislature. This text provides a comprehensive overview of product-specific, international and country-specific licensing requirements and general regulatory issues in biotechnology.

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... -international regulation and deregulation -venture capitalist investment -the IND process -informed consent -changes in manufacturing and updated and extended coverage of... -pediatric drug trial design -the advantages and disadvantages of orphan drug designations -the maximization of package inserts for marketing -post approval safety surveillance -withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues. This expansion has made it difficult for any one individual to become a full-fledged expert in all areas. Fulfilling the need for a wide-ranging guide to the many existing subspecialties in this field, Pharmacokinetics in Drug Discovery and Development details the different areas in the field providing the ideal comprehensive, quick access text and reference.

After an introduction of basic principles, the book is divided into sections that cover industrial and regulatory applications, clinical applications, and research applications. The following sections cover such topics as PK/PD approaches, clinical pharmacokinetic monitoring, population pharmacokinetics, linear systems approaches, and more. Fourteen authors, each an expert in his/her area of expertise, provide an extensive background into the subspeciality with emphasis on the section's theme. Covering the many sub-disciplines and providing pharmacokinetic concepts, terminology, and approaches, Pharmacokinetics in Drug Discovery and Development serves as a resource for professionals throughout this field.

This reference outlines important applications of statistics for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation in order to establish the safety and efficacy of pharmaceutical compounds. Reinforcing the role of good statistical practices (GSP) in drug research and formulation, Statistics in Drug Research is an essential source for biostatisticians; pharmacologists; clinical, industrial, and research pharmacists; statisticians and applied statisticians; biometricians; quality control personnel; drug regulatory personnel; and upper-level undergraduate and graduate students in these disciplines.

Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.

This book details several important medicinal plants, their occurrence, plant compounds and their chemical structures, and pharmacological properties against various human diseases. It also gives information on isolation and structural elucidation of phytocompounds, bio-assays, metabolomic studies, and therapeutical applications of plant compounds.

This set of six volumes provides a systematic and standardized description of 23,033 chemical components isolated from 6,734 medicinal plants, collected from 5,507 books/articles published in Chinese and international journals. A chemical structure with stereo-chemistry bonds is provided for each chemical component, in addition to conventional information, such as Chinese and English names, physical and chemical properties. It includes a name list of medicinal plants from which the chemical component was isolated. Furthermore, abundant pharmacological data for nearly 8,000 chemical components are presented, including experimental method, experimental animal, cell type, quantitative data, as well as control compound data. The seven indexes allow for complete cross-indexing. Regardless whether one searches for the molecular formula of a compound, the pharmacological activity of a compound, or the English name of a plant, the information in the book can be retrieved in multiple ways.

This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals.
Addresses the complexities of globalizing redundancy in filtration
Enabling educated developmental, procedural, and regulatory judgments to be made in the manufacturing of sterile health care products, Sterile Filtration
considers how many filters should be in the process stream
examines the existence of nanobacteria and viable but nonculturable organisms
covers pore size designations, distributions, architecture, and numbers
discusses the latest findings in bubble point and diffuse flow measurements
describes pre- and postfiltration, up- and downstream testing, and after-stream sterilizations
details wetting liquid, polymer, temperature, and water purity effects
explains sieve retention, size exclusion, adsorptive sequestrations, charge-related phenomena, gravitational settling, and interference factors in liquids and gases
outlines filter validation, requirements, and operational specifics
and more
Advocating separation in addition to physical destruction of microorganisms, Sterile Filtration is a reference essential for pharmaceutical scientists; biotechnologists; microbiologists; virologists; process and chemical engineers; plant, production, validation, and quality control managers in the pharmaceutical and biotechnology industries; and upper-level undergraduate and graduate school students in these disciplines.

Interactions between drug particulates are crucial in determining drug dispersion and deaggregation, and ultimately delivery efficiency. This book combines principles and factors in pharmaceutical powder technology, critically reviews some of the studies carried out in dry powder formulation development, and proposes possible strategies for improving their efficiency. The majority of these principles are applicable to other pharmaceutical solid dosage forms (e.g. tablets and capsules.).

eBook available with sample pages: 0203209591

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 Book explains and investigates how medicines are controlled in Europe, especially the EU. Based on penetrating documentary and interview research with the pharmaceutical industry, regulators and consumer organisations,it provides the first major critical examination of the new Europeanised systems of medicine regulation. The authors argue that the drive to produce and approve more drugs more quickly for a single European market dominates other considerations, such as improvements in democratic accountability, the independence of regulators and scientific expertise from commercial interests, and drug safety testing and surveillance.

Interactions Between Chinese Herbal Medicinal Products and Orthodox Drugs provides basic biomedical principles on adverse and beneficial interactions between Chinese herbal medicine (CHM) products (herbs and ready-made medications) and orthodox drugs. The book includes concise accounts of the trends of development and progress in Chinese medicine, pharmacological principles of CHM materials and mechanisms of interactions. Clinically relevant interactions are summarized in tables for easy reference with a catalogue of commonly used CHM products.
A unique chapter with an action plan is assigned to promote research and documentation of herb-drug interactions. This textbook is desperately needed by undergraduates, postgraduates, medical practitioners, health professionals, medications regulatory bodies, and R&D professionals in pharmaceutical industries who are involved in CHM products.

Natural products play an integral and ongoing role in promoting numerous aspects of scientific advancement, and many aspects of basic research programs are intimately related to natural products. The significance, therefore, of the Studies in Natural Product Chemistry series, edited by Professor Atta-ur-Rahman, cannot be overestimated. This volume, in accordance with previous volumes, presents us with cutting-edge contributions of great importance.

Sustained-Release Injectable Products focuses on the development process for sustained-release versions of drugs and delivery systems and administration routes. From the rationale and basic product development principles to regulatory issues and the approval process, expert contributions address virtually every aspect. They bring together common threads that apply to any sustained-release formulation, such as scale-up, safety, biocompatibility, analytical challenges, and quality assurance.

This timely and compact monograph addresses how to determine drug permeability across the blood-brain barrier more effectively. Focusing on the physiological mechanisms that influence the passage of agents into the brain, the book covers the latest research on the blood-brain barrier, the current problems of and solutions to drug delivery to the central nervous system (CNS), existing strategies, and prospects for future research. Avoid excessive in vivo experimentation and utilize timesaving in vitro techniques. A concise reference with reviews from nearly 40 international specialists in diverse fields, The Blood-Brain Barrier and Drug Delivery to the CNS -assesses the properties of the blood-brain barrier to determine and measure drug permeability in animals and humans -presents techniques to predict successful drug uptake through in vitro systems or by computation of physicochemical parameters -examines the multidrug resistance protein P-glycoprotein as a natural transporter -analyzes current drug designs to known requirements for transport -looks at drug delivery systems for the brain -and much more! Densely packed with over 800 literature references, drawings, photographs, x-rays, tables, and equations, The Blood-Brain Barrier and Drug Delivery to the CNS is a vital addition to the bookshelves of biochemists, pharmacists, clinical and research pharmacologists, neuroscientists and neurologists, and graduate and medical school students in these disciplines.

Thiscomprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book:

Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines

Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures

Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers

This book is a useful resource to scientists and researchers in bothindustry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development."

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.