Drug Products for Clinical Trials Second Edition

Author: Donald Monkhouse
Publisher: CRC Press
ISBN: 082475462X
Format: PDF, Docs
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Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection of chapters on the current and evolving state of clinical supplies operations by esteemed researchers and consultants in industry.

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition

Author: Allen Cato
Publisher: CRC Press
ISBN: 0824744802
Format: PDF, ePub, Mobi
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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.

Drug Products for Clinical Trials Second Edition

Author: Donald Monkhouse
Publisher: Taylor & Francis US
ISBN: 0849352762
Format: PDF, Mobi
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Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection of chapters on the current and evolving state of clinical supplies operations by esteemed researchers and consultants in industry.

Pharmaceutical Stress Testing

Author: Steven W. Baertschi
Publisher: CRC Press
ISBN: 1439801800
Format: PDF, ePub
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The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years. Key features include: A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience. 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations Updated methodologies for predicting drug stability and degradation pathways Best practice models to follow An expanded Frequently Asked Questions section This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).

Handbook of Bioequivalence Testing Second Edition

Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1482226375
Format: PDF, ePub
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As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.

Generic Drug Product Development

Author: Leon Shargel
Publisher: CRC Press
ISBN: 1420086359
Format: PDF, Mobi
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In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.

Biosimilar Drug Product Development

Author: Laszlo Endrenyi
Publisher: CRC Press
ISBN: 1498718809
Format: PDF
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When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Basic Statistics and Pharmaceutical Statistical Applications Second Edition

Author: James E. De Muth
Publisher: CRC Press
ISBN: 9780849337994
Format: PDF, Mobi
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The first edition of Basic Statistics and Pharmaceutical Statistical Applications successfully provided a practical, easy-to-read, basic statistics book. This second edition not only updates the previous edition, but expands coverage in the area of biostatistics and how it relates to real-world professional practice. Taking you on a roller coaster ride through the world of statistics, Dr. De Muth clearly details the methodology necessary to summarize data and make informed decisions about observed outcomes. What's new or different in the Second Edition? New chapters cover: Measures of association primarily with nominal and ordinal data and and more than 15 tests Survival statistics including actuarial analysis and an introduction to multiple regression with survival data using proportional hazards regression An introduction to the topic of evidence-based practice with discussions of sensitivity and specificity, predictive values, and likelihood ratios Odds ratios and relative risk ratios that provide valuable information for dealing with probability, odds, and risk New sections address Power and sample size determination for two-sample Z-tests of proportions Clinical equivalence and noninferiority studies, process capability, and tolerance limits Methods for assessing repeatability and reproducibility Expanded information includes: Chi square, repeated measures designs, Latin Square designs, nine multiple comparison tests, and outlier testing Inverse prediction with linear regression, handling of multiple data points at different levels of independent variable, and assessment of parallelism of slopes for two samples Additional types of bivariate correlations and various assessments for independence and randomness More nonparametric tests including new information on post hoc comparisons for a significant Kruskal-Wallis test, the Kolmogorov-Smirnov goodness-of-fit test, and the Anderson-Darling test, as well as runs and range tests Eight new tables useful for the interpretation of some of the new inferential statistics De Muth provides concrete examples that enable you to effectively manage information in your day-to-day problem solving and reporting of findings. By avoiding heavy-duty mathematics and theory, even the mathematically challenged can benefit and increase their confidence in using statistics procedures.

Statistics In the Pharmaceutical Industry 3rd Edition

Author: Charles Ralph Buncher
Publisher: CRC Press
ISBN: 9780824790738
Format: PDF, ePub, Mobi
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This rewritten and updated second edition provides comprehensive information on the wide-ranging applications of statistics in the pharmacological field. Focusing on practical aspects, it sets out to bridge the gap between industry and academia.;Reflecting the changes that have taken place since publication of the first edition, this volume covers new topics such as: cancer clinical trials, clinical trials of AIDS patients and animal tumorigenicity studies; the development of antiepileptic drugs; the role of epidemiology in postmarketing trials and adverse drug experience; computer-assisted new drug application (CANDA) submissions; contract research organizations; interim analysis in clinical trials; and room-temperature tests for the stability of drugs.;This work is intended as: a reference for statisticians, biostatisticians, pharmacologists, administrators, managers, and scientists in the pharmaceutical industry; and a text for graduate students taking courses in applied statistics or pharmaceutical statistics.

Handbook of Toxicology Second Edition

Author: Michael J. Derelanko
Publisher: CRC Press
ISBN: 9780849303708
Format: PDF, ePub, Docs
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LOCATE FREQUENTLY USED INFORMATION EASILY AND QUICKLY Working in the laboratory or office, you use a diverse assortment of basic information to design, conduct, and interpret toxicology studies and to perform risk assessments. The Second Edition of the best-selling Handbook of Toxicology gives you the information you need in a single reference source. NEW IN THIS EDITION: Expanded coverage of inhalation toxicology, neurotoxicology, and histopathology Additional regulatory chapters dealing with pesticides, medical devices, consumer products, and world-wide notification of new chemicals Areas of toxicology missing from the first edition such as ecotoxicology and in vitro toxicology A chapter providing extensive overview of the toxicology of metals Two chapters on basic male and female endocrinology and related toxicology Information on differences in physiological and biochemical parameters between children and adults References to Web site sources of valuable information Over 200 new tables and figures THE SINGLE SOURCE FOR THE INFORMATION YOU USE MOST FREQUENTLY Updated and expanded, this unique book includes practical reference information useful to toxicologists in the chemical and pharmaceutical industries, contract laboratories, regulatory agencies, and academia. To help you find information quickly and easily, data is arranged by toxicology subspecialty and each chapter begins with a detailed listing of information presented. Containing over 700 tables and figures, Handbook of Toxicology, Second Edition gives you a single source for the information you use most often.