Practical Process Research and Development


Book Description

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




Practical Process Research & Development


Book Description

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




Practical Process Research and Development


Book Description

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




Software Process Improvement and Management: Approaches and Tools for Practical Development


Book Description

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


Book Description

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




Impact Evaluation in Practice, Second Edition


Book Description

The second edition of the Impact Evaluation in Practice handbook is a comprehensive and accessible introduction to impact evaluation for policy makers and development practitioners. First published in 2011, it has been used widely across the development and academic communities. The book incorporates real-world examples to present practical guidelines for designing and implementing impact evaluations. Readers will gain an understanding of impact evaluations and the best ways to use them to design evidence-based policies and programs. The updated version covers the newest techniques for evaluating programs and includes state-of-the-art implementation advice, as well as an expanded set of examples and case studies that draw on recent development challenges. It also includes new material on research ethics and partnerships to conduct impact evaluation. The handbook is divided into four sections: Part One discusses what to evaluate and why; Part Two presents the main impact evaluation methods; Part Three addresses how to manage impact evaluations; Part Four reviews impact evaluation sampling and data collection. Case studies illustrate different applications of impact evaluations. The book links to complementary instructional material available online, including an applied case as well as questions and answers. The updated second edition will be a valuable resource for the international development community, universities, and policy makers looking to build better evidence around what works in development.




Clinical Practice Guidelines We Can Trust


Book Description

Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.




Robust Process Development and Scientific Molding


Book Description

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.




A Practical Guide to Managing Clinical Trials


Book Description

A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.




Practical Process Control


Book Description

Practical Process Control (loop tuning and troubleshooting). This book differs from others on the market in several respects. First, the presentation is totally in the time domain (the word "LaPlace" is nowhere to be found). The focus of the book is actually troubleshooting, not tuning. If a controller is "tunable", the tuning procedure will be straightforward and uneventful. But if a loop is "untunable", difficulties will be experienced, usually early in the tuning effort. The nature of any difficulty provides valuable clues to what is rendering the loop "untunable". For example, if reducing the controller gain leads to increased oscillations, one should look for possible interaction with one or more other loops. Tuning difficulties are always symptoms of other problems; effective troubleshooting involves recognizing the clues, identifying the root cause of the problem, and making corrections. Furthermore, most loops are rendered "untunable" due to some aspect of the steady-state behavior of the process. Consequently, the book focuses more on the relationship of process control to steady-state process characteristics than to dynamic process characteristics. One prerequisite to effective troubleshooting is to "demystify" some of the characteristics of the PID control equations. One unique aspect of this book is that it explains in the time domain all aspects of the PID control equation (including as the difference between the parallel and series forms of the PID, the reset feedback form of the PID equation, reset windup protection, etc.) The book stresses an appropriate P&I (process and instrumentation) diagram as critical to successful tuning. If the P&I is not right, tuning difficulties are inevitable. Developing and analyzing P&I diagrams is a critical aspect of troubleshooting.