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

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.

Provides instructions on small-scale soap production methods. A practical introduction, with many illustrations, based on the author's experiences in Ghana.

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.

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.

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.

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.

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.

The Life-Cycle of Pharmaceuticals in the Environment identifies pathways of entry of pharmaceuticals into the environment, beginning with the role of global prescribing and disposal practices. The book then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and in potable water. In addition, sections examine methods currently available to degrade pharmaceuticals in natural waters and some of their ecotoxicological impacts, along with future considerations and the growing concept of product stewardship.

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.

Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis, and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The contributors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials. Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real life applications. Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium. Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee.

Finding consistent, analytical discussions of processes and principles of lyophilization can be challenging and often frustrating. The first resource to gather information about the field, Lyophilization: Introduction and Basic Principles is still the book to have on lyophilization. Presenting information in an easy-to-read style, the book comprehensively and authoritatively covers the field. Using plain, unpretentious language, author Thomas A. Jennings pulls together information from diverse sources to provide an authoritative compendium of the lyophilization process and its basic principles. He provides important discussions about the nature of the container-closure system and the equipment, tools, and environments required. Case studies and examples of solutions illustrate the many ways problems can be addressed in the lyophilization process. The book covers: -Properties of lyophilized materials -Product formulation requirements and the thermal properties of formulations -Importance of process water -Phase changes -Thermal analytical methods -Freezing, primary, and secondary drying processes -Effect of vacuum freeze-dryers, both now and in the future Including over 150 illustrations, global symbols, and more than 350 references, this book is the complete guide to lyophilization, its analytical methods, measurement of process parameters, and equipment.

Reveals important new results from clinical trials conducted in Scandinavia, Scotland, Australia, Canada, and the United States. This timely reference reviews the vast body of clinical trial evidence supporting the once controversial view that high levels of serum cholesterol are a major risk factor in coronary heart disease (CHD). The studies presented in Cholesterol-Lowering Therapy: Evaluation of Clinical Trial Evidence promote cholesterol reduction as a highly successful means of preventing heart disease in various populations. Investigates past, current, and upcoming controlled clinical trials of cholesterol-reduction therapies, comparing effects of statins and bile acid sequestrants to triglyceride-lowering drugs and antioxidants. Written by more than 25 distinguished international researchers, Cholesterol-Lowering Therapy: Evaluation of Clinical Trial Evidence -highlights historical studies of dietary trials designed to reduce CHD -covers tests of HMG CoA reductase inhibitors for patients with and without CHD -illuminates CHD risk factors such as diabetes, hypertension, obesity, and smoking -explores blood levels of homocysteine and lipoprotein(a) and other recently identified CHD risk factors -reviews metabolism of lipoproteins expressed in high (HDL) and low (LDL) density lipoprotein cholesterol -and more! Containing over 700 instructive tables, drawings, photographs, and bibliographic citations, Cholesterol-Lowering Therapy: Evaluation of Clinical Trial Evidence is a must-read resource for cardiologists, pharmacologists, and upper-level undergraduate, graduate, and medical school students in these disciplines.

This invaluable reference presents a comprehensive review of the basic methods for characterizing bioadhesive materials and improving vehicle targeting and uptake-offering possibilities for reformulating existing compounds to create new pharmaceuticals at lower development costs.
Evaluates the unique carrier characteristics of bioadhesive polymers and their power to enhance localization of delivered agents, local bioavailability, and drug absorption and transport
Written by over 50 international experts and reflecting broad knowledge of both traditional bioadhesive strategies and novel clinical applications, Bioadhesive Drug Delivery Systems
discusses mechanical and chemical bonding, polymer-mucus interactions, the effect of surface energy in bioadhesion, polymer hydration, and mucus rheology
analyzes biochemical properties of mucus and glycoproteins, cell adhesion molecules, and cellular interaction with two- and three-dimensional surfaces
covers microbalances and magnetic force transducers, atomic force microscopy, direct measurements of molecular level adhesions, and methods to measure cell-cell interactions
examines bioadhesive carriers, diffusion or penetration enhancers, and lectin-targeted vehicles
describes vaginal, nasal, buccal, ocular, and transdermal drug delivery
reviews bioadhesive interactions with the mucosal tissues of the eye and mouth, and those in the respiratory, urinary, and gastrointestinal tracts
explores issues of product development, clinical testing, and production
and more
Amply referenced with over 1400 bibliographic citations, and illustrated with more than 300 drawings, photographs, tables, and display equations, Bioadhesive Drug Delivery Systems serves as a sound basis for innovation in bioadhesive systems and an excellent introduction to the subject. This unique reference is ideal for pharmaceutical scientists and technologists; chemical, polymer, and plastics engineers; biochemists; physical, surface, and colloid chemists; biologists; and upper-level undergraduate and graduate students in these disciplines.

This book highlights recently discovered aspects of "middle-size molecules," focusing on (1) their unique bio-functions on the basis of derivatives and conjugates of natural products, saccharides, peptides, and nucleotides; (2) the synthesis of structurally complex natural products; (3) special synthetic methods for -conjugated functional molecules; and (4) novel synthetic methods using flow chemistry. Given its scope, the book is of interest to industrial researchers and graduate students in the fields of organic chemistry, medicinal chemistry, and materials science.

Providing guidance for chemists and other scientists entering pharmaceutical discovery and development, this up-to-the-minute reference presents contributions from an international group of nearly 50 renowned researchersa "offering a solid grounding in synthetic "and" physical organic chemistry, and clarifying the roles of various specialties in the development of new drugs.

Featuring over 1000 references, tables, and illustrations, "Process Chemistry in the Pharmaceutical Industry" is sure to find its way to the bookshelves of organic, physical, analytical, process, and medicinal chemists and biochemists; pharmacists; and upper-level undergraduate and graduate students in these disciplines.

Bringing together nearly forty collaborators from academic and industrial laboratories, this reference furnishes an overview of the subject from a historical, kinetic, and chemical context. A source of expertise for a rapidly changing and expanding field, the book provides a framework for drug metabolism in drug discovery and development. Containing tables, drawings, photographs, and equations, it highlights the importance of pharmacokinetics and cytochrome P450, explains clearance, volume of distribution, sequential metabolism, and nonlinear kinetics, summarizes concepts of Phase 1 and 2 metabolites, evaluates tertiary amine metabolism and reactive metabolite chemistry, and more.