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Author: Behnam Davani Publisher: John Wiley & Sons ISBN: 1119425034 Category : Science Languages : en Pages : 258
Book Description
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.
Author: Behnam Davani Publisher: John Wiley & Sons ISBN: 1119425034 Category : Science Languages : en Pages : 258
Book Description
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.
Author: Christopher M. Riley Publisher: Elsevier ISBN: 0081028253 Category : Science Languages : en Pages : 696
Book Description
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. - Presents a critical assessment of the application of ICH guidelines on method validation and specification setting - Written by subject-matter experts involved in the development and application of the guidelines - Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products - Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
Author: United States Pharmacopeial Convention Publisher: U.S. Pharmacopeia ISBN: 9781936424009 Category : Catalogs, Drug Languages : en Pages : 0
Book Description
The USP-NF is a combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. USP-NF standards are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. Learn more about USP-NF. Highlights & Features: * More than 4,500 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. View a sample USP-NF monograph (100KB). * Over 230 General Chapters providing clear, step-by-step guidance for assays, tests, and procedures * Focus-specific charts and a combined index helps you find the information you need * Helpful sections on reagents, indicators, and solutions, plus reference tables * Published annually in an official English edition (print, CD, and new USB flash drive formats ) and an official Spanish edition (print).
Author: Larry L. Augsburger Publisher: CRC Press ISBN: 1841849774 Category : Medical Languages : en Pages : 436
Book Description
Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.
Author: Terrence P. Tougas Publisher: Springer Science & Business Media ISBN: 1461462967 Category : Medical Languages : en Pages : 443
Book Description
The purpose of this publication is to introduce a new, simpler and more effective way in which to interpret pharmaceutical aerosol particle size data from orally inhaled products (OIPs). Currently, the compendial and regulatory requirements dictate the need for measurements by full resolution multi-stage cascade impactor (CI), a process that is demanding for the operator, time consuming, prone to experimental error, and challenging for method transfers from one laboratory to another. Furthermore, we shall show that the current practice of reducing information from mass-weighted aerodynamic particle size distribution (APSD) measurements through the use of CI stage groupings is not the most effective decision-making tool for OIP quality control (QC) in comparison with newly introduced, mutually-independent efficient data analysis (EDA) metrics that can be derived either from full resolution or abbreviated impactor measurements (AIM).
Author: Q. Alan Xu Publisher: John Wiley & Sons ISBN: 1118533984 Category : Technology & Engineering Languages : en Pages : 342
Book Description
Explores both the benefits and limitations of new UHPLC technology High performance liquid chromatography (HPLC) has been widely used in analytical chemistry and biochemistry to separate, identify, and quantify compounds for decades. The science of liquid chromatography, however, was revolutionized a few years ago with the advent of ultra-high performance liquid chromatography (UHPLC), which made it possible for researchers to analyze sample compounds with greater speed, resolution, and sensitivity. Ultra-High Performance Liquid Chromatography and Its Applications enables readers to maximize the performance of UHPLC as well as develop UHPLC methods tailored to their particular research needs. Readers familiar with HPLC methods will learn how to transfer these methods to a UHPLC platform and vice versa. In addition, the book explores a variety of UHPLC applications designed to support research in such fields as pharmaceuticals, food safety, clinical medicine, and environmental science. The book begins with discussions of UHPLC method development and method transfer between HPLC and UHPLC platforms. It then examines practical aspects of UHPLC. Next, the book covers: Coupling UHPLC with mass spectrometry Potential of shell particles in fast liquid chromatography Determination of abused drugs in human biological matrices Analyses of isoflavones and flavonoids Therapeutic protein characterization Analysis of illicit drugs The final chapter of the book explores the use of UHPLC in drug metabolism and pharmacokinetics studies for traditional Chinese medicine. With its frank discussions of UHPLC's benefits and limitations, Ultra-High Performance Liquid Chromatography and Its Applications equips analytical scientists with the skills and knowledge needed to take full advantage of this new separation technology.
Author: Sougata Jana Publisher: Springer Nature ISBN: 9811647879 Category : Medical Languages : en Pages : 453
Book Description
This book is focused on marine based biomedical carriers for delivery of therapeutics. Marine biomaterials and bio-based carriers show wide applications in pharmaceutical as well as biomedical fields for delivery of small and large molecules. Biomaterial-based composites, scaffolds or matrix systems are promising systems for controlled and prolonged release of drug in target site and control the premature release of drugs or bioactive compounds. This book discusses the targeted delivery of drugs and therapeutic applications. It also describes the use of marine biopolymers in cancer therapy. Different chapters describe the tissue engineering techniques to develop these carriers. The marine biomaterial-based systems are widely used for tissue engineering, and biomedical imaging. This book is meant for industry experts, students and researchers in the area of pharmaceutical sciences, biomedical engineering and material science and pharmacology.
Author: Heewon Lee Publisher: CRC Press ISBN: 1439874204 Category : Medical Languages : en Pages : 540
Book Description
A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text: Explores the safety, quality, and regulatory aspects of GTIs Provides an overview of the latest FDA and EMEA guidelines Explains the how and why of various GTI control tactics and practices Describes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testing Includes real-life examples of GTI control in drug substance and drug product development processes Containing case studies from large and small pharmaceutical firms in multiple geographical regions, Pharmaceutical Industry Practices on Genotoxic Impurities supplies an overview of—and a current framework for—GTI control in the pharmaceutical industry, demonstrating how proper management of GTIs can occur with the appropriate guidance, a firm grasp of the practical implications, and effective information sharing between disciplines.
Author: Harry G. Brittain Publisher: Academic Press ISBN: 0124078281 Category : Science Languages : en Pages : 514
Book Description
Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. - Contributions from leading authorities - Informs and updates on all the latest developments in the field
Author: Behnam Davani
Author: Behnam Davani
Author: Christopher M. Riley
Author: 
Author: United States Pharmacopeial Convention
Author: Larry L. Augsburger
Author: Terrence P. Tougas
Author: Q. Alan Xu
Author: Sougata Jana
Author: Heewon Lee
Author: Harry G. Brittain