Analytical Testing for the Pharmaceutical GMP Laboratory

Biocatalysis is rapidly evolving into a key technology for the discovery and production of chemicals, especially in the pharmaceutical industry, where high yielding chemo-, regio-, and enantioselective reactions are critical. Taking the latest breakthroughs in genomics and proteomics into consideration, Biocatalysis for the Pharmaceutical Industry concisely yet comprehensively discusses the modern application of biocatalysis to drug discovery, development, and manufacturing. Written by a team of leading experts, the book offers deep insight into this cutting edge field. Covers a wide range of topics in a systematic manner with an emphasis on industrial applications Provides a thorough introduction to the latest biocatalysts, modern expression hosts, state-of-the-art directed evolution, high throughput screening, and bioprocess engineering Addresses frontier subjects such as emerging enzymes, metabolite profiling, combinatorial biosynthesis, metabolic engineering, and autonomous enzymes for the synthesis and development of chiral molecules, drug metabolites, and semi-synthetic medicinal compounds and natural product analogs Highlights the impact of biocatalysis on green chemistry Contains numerous graphics to illustrate concepts and techniques Biocatalysis for the Pharmaceutical Industry is an essential resource for scientists, engineers, and R&D policy makers in the fine chemical, pharmaceutical, and biotech industries. It is also an invaluable tool for academic researchers and advanced students of organic and materials synthesis, chemical biology, and medicinal chemistry.

Explore the properties of a wide range of dental materials used in restorative dentistry with a brand-new resource The Manual of Laboratory Testing Methods for Dental Restorative Materials delivers a comprehensive and accessible review of the materials used in restorative dentistry. The book offers readers an evidence-based application of the materials and their mechanical, physical, and optical properties. Each chapter begins with key points and includes a glossary to aid in the learning and retention of the material contained within. The book also covers the methods used to study the properties and the advantages and disadvantages of various dental restorative materials as well as why they are selected. The Manual of Laboratory Testing Methods for Dental Restorative Materials will be a helpful addition to any institute library or personal collection and will cater to the needs of postgraduate dental students, researchers and academics in the fields of dentistry and material sciences.

… this text takes a novel approach… The style… is not as dry as other statistics texts, and so should not be intimidating even to a relative newcomer to the subject… The layout is easy to navigate, there are chapter aims, summaries and “key point boxes” throughout. -The Pharmaceutical Journal, 2008 This text is a clear, accessible introduction to the key statistical techniques employed for the analysis of data within this subject area. Written in a concise and logical manner, the book explains why statistics are necessary and discusses the issues that experimentalists need to consider. The reader is carefully taken through the whole process, from planning an experiment to interpreting the results, avoiding unnecessary calculation methodology. The most commonly used statistical methods are described in terms of their purpose, when they should be used and what they mean once they have been performed. Numerous examples are provided throughout the text, all within a pharmaceutical context, with key points highlighted in summary boxes to aid student understanding. Essential Statistics for the Pharmaceutical Sciences takes a new and innovative approach to statistics with an informal style that will appeal to the reader who finds statistics a challenge! This book is an invaluable introduction to statistics for any science student. It is an essential text for students taking biomedical or pharmaceutical-based science degrees and also a useful guide for researchers.

HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry. In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided. This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development. The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.

Develop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations In Laboratory Control System Operations in a GMP Environment , readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System. Designed to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment Qualification and Calibration, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices. Additionally, a chapter outlining Stability Program operations is included in the text. In addition to these topics, it includes LCS information and tools such as: ● End of chapter templates, checklists, and LCS guidance to help you follow the required standards ● Electronic versions of each tool so users can use them outside of the text ● An In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systems For quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.

A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

The first book dedicated specifically to automated sample preparation and analytical measurements, this timely and systematic overview not only covers biological applications, but also environmental measuring technology, drug discovery, and quality assurance. Following a critical review of realized automation solutions in biological sciences, the book goes on to discuss special requirements for comparable systems for analytical applications, taking different concepts into consideration and with examples chosen to illustrate the scope and limitations of each technique.

Drinking water policies and research are intimately linked. It is thanks to the scientific progress made over the last 25 years in identifying and controlling toxic products in drinking water that regulations have developed in such a way that the protection of public health from waterborne diseases has drastically improved. The integration of research outputs into the policy-making progress requires close cooperation among the scientific and policy communities, which is not always straightforward. Exchanges among scientific and policy-making communities are certainly representing key elements of progress for a better environmental protection. In this respect, analytical developments linked to drinking water are at the core of the science-policy debate. This book «Analytical Methods for Drinking Water: Advances in Sampling and Analysis» reflects this awareness in joining recent analytical developments with policy considerations. A first chapter gives an overview of EU and US drinking water policies, as well as on standardization. Analytical developments are described in depth in the second chapter, focusing on bromate in drinking water. The third chapter deals with the development of a sampling protocol for lead in drinking water, thus mixing analytical development with standardization needs. Finally, the fourth chapter focuses on standardization aspects (pre-normative research) related to materials in contact with drinking water. This book, written by experts in the field of drinking water policy and analysis, illustrates recent scientific advances in this area, which have contributed to policy development and will be of direct use to policy-makers, water scientists, researchers and analytical laboratories.

This third volume in a four-volume set offers new theories and applications for the diagnosis and treatment of mental disorders. Having laid the groundwork in the first two volumes, the authors now embark on significant, real-life scenarios that apply their philosophy to mental disorder treatments. The goal of the project is to take the industry toward sustainability, not just in terms of the chemical engineering used to create medicines, but also environmentally, economically, and personally. Their unique approach uses a more holistic and philosophically cohesive method for treating mental disorders, making the industry «greener» and the patient healthier. The four volumes in «The Greening of Pharmaceutical Engineering» are: Volume 1: Practice, Analysis, and Methodology Volume 2: Theories and Solutions Volume 3: Applications for Mental Disorder Treatments Volume 4: Applications for Physical Disorder Treatments This ground-breaking set of books is a unique and state-of-the-art study that only appears here, within these pages. A fascinating study for the engineer, scientist, and pharmacist working in the pharmaceutical industry and interested in sustainability, it is also a valuable textbook for students and faculty studying these subjects.