Designed to provide a comprehensive, step-by-step approach to organic process research and development in the pharmaceutical, fine chemical, and agricultural chemical industries, this book describes the steps taken, following synthesis and evaluation, to bring key compounds to market in a cost-effective manner. It describes hands-on, step-by-step, approaches to solving process development problems, including route, reagent, and solvent selection; optimising catalytic reactions; chiral syntheses; and "green chemistry." Second Edition highlights:• Reflects the current thinking in chemical process R&D for small molecules• Retains similar structure and orientation to the first edition. • Contains approx. 85% new material• Primarily new examples (work-up and prospective considerations for pilot plant and manufacturing scale-up)• Some new/expanded topics (e.g. green chemistry, genotoxins, enzymatic processes)• Replaces the first edition, although the first edition contains useful older examples that readers may refer to - Provides insights into generating rugged, practical, cost-effective processes for the chemical preparation of "small molecules" - Breaks down process optimization into route, reagent and solvent selection, development of reaction conditions, workup, crystallizations and more - Presents guidelines for implementing and troubleshooting processes

This book provides a comprehensive, step-by-step approach to organic process research and development in the pharmaceutical, fine chemical, and agricultural chemical industries. Process R&D describes the steps taken, following synthesis and evaluation, to bring key compounds to market in a cost-effective manner. More people are being hired for work in this area as increasing numbers of drug candidates are identified through combinatorial chemistry and high-throughput screening. The book is directed to industrial (primarily organic) chemists, and academicians (particularly those involved in a growing number of start-up companies) and students who need insight into industrial process R&D. Current books do not describe hands-on, step-by-step, approaches to solving process development problems, including route, reagent, and solvent selection; optimising catalytic reactions; chiral syntheses; and "green chemistry." "Practical Process Research and Development" will be a valuable resource for researchers, managers, and graduate students. * Provides insights into generating rugged, practical, cost-effective processes for the chemical preparation of "small molecules" * Breaks down process optimization into route, reagent and solvent selection, development of reaction conditions, workup, crystallizations and more * Includes over 100 tips for rapid process development * Presents guidelines for implementing and troubleshooting processes

Designed to provide a comprehensive, step-by-step approach to organic process research and development in the pharmaceutical, fine chemical, and agricultural chemical industries, this book describes the steps taken, following synthesis and evaluation, to bring key compounds to market in a cost-effective manner. It describes hands-on, step-by-step, approaches to solving process development problems, including route, reagent, and solvent selection; optimising catalytic reactions; chiral syntheses; and "green chemistry." Second Edition highlights: . Reflects the current thinking in chemical process R&D for small molecules . Retains similar structure and orientation to the first edition. . Contains approx. 85% new material . Primarily new examples (work-up and prospective considerations for pilot plant and manufacturing scale-up) . Some new/expanded topics (e.g. green chemistry, genotoxins, enzymatic processes) . Replaces the first edition, although the first edition contains useful older examples that readers may refer to Provides insights into generating rugged, practical, cost-effective processes for the chemical preparation of "small molecules" Breaks down process optimization into route, reagent and solvent selection, development of reaction conditions, workup, crystallizations and more Presents guidelines for implementing and troubleshooting processes

Over the past decade, there has been an increase in attention and focus on the discipline of software engineering. Software engineering tools and techniques have been developed to gain more predictable quality improvement results. Process standards such as Capability Maturity Model Integration (CMMI), ISO 9000, Software Process Improvement and Capability dEtermination (SPICE), Agile Methodologies, and others have been proposed to assist organizations to achieve more predictable results by incorporating these proven standards and procedures into their software process. Software Process Improvement and Management: Approaches and Tools for Practical Development offers the latest research and case studies on software engineering and development. The production of new process standards assist organizations and software engineers in adding a measure of predictability to the software process. Companies can gain a decisive competitive advantage by applying these new and theoretical methodologies in real-world scenarios. Researchers, scholars, practitioners, students, and anyone interested in the field of software development and design should access this book as a major compendium of the latest research in the field.

Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: - Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms - Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies - New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development - The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards - It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter - A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government

The book introduces the reader to the concepts of Scientific Molding and Scientific Processing for Injection Molding, geared towards developing a robust, repeatable, and reproducible (3Rs) molding process. The effects of polymer morphology, thermal transitions, drying, and rheology on the injection molding process are explained in detail. The development of a robust molding process is broken down into two sections and is described as the Cosmetic Process and the Dimensional Process. Scientific molding procedures to establish a 3R process are provided. The concept of Design of Experiments (DOEs) for and in injection molding is explained, providing an insight into the cosmetic and dimensional process windows. A plan to release qualified molds into production with troubleshooting tips is also provided. Topics that impact a robust process such as the use of regrind, mold cooling, and venting are also described. Readers will be able to utilize the knowledge gained from the book in their day-to-day operations immediately. The second edition includes a completely new chapter on Quality Concepts, as well as much additional material throughout the book, covering fountain flow, factors affecting post mold shrinkage, and factor selections for DOEs. There are also further explanations on several topics, such as in-mold rheology curves, cavity imbalances, intensification ratios, gate seal studies, holding time optimization of hot runner molds, valve gated molds, and parts with large gates. A troubleshooting guide for common molded defects is also provided.