Drug Products for Clinical Trials Second Edition

Author: Donald Monkhouse
Publisher: CRC Press
ISBN: 082475462X
Format: PDF, Kindle
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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.

Preclinical Drug Development Second Edition

Author: Mark Rogge
Publisher: CRC Press
ISBN: 9781420084726
Format: PDF, Mobi
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Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials. Highlights of the Second Edition include: Pharmacokinetics Modeling and simulation Formulation and routes of administration Toxicity evaluations The assessment of drug absorption and metabolism Interspecies scaling Lead molecule selection and optimization via profiling Screening using in silico and in vitro toxicity evaluations The book also includes case studies on preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development, a review of ICH preclinical guidelines, and experimental methods used to study membrane drug transport and metabolism. This guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.

Drugs

Author: Rick Ng
Publisher: John Wiley & Sons
ISBN: 1118907191
Format: PDF, Kindle
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The third edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, Drugs: From Discovery to Approval, Third Edition quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. The third edition incorporates the latest developments and updates in the pharmaceutical community, provides more comprehensive coverage of topics, and includes more materials and case studies suited to college and university use. Biotechnology is a dynamic field with changes across R&D, clinical trials, manufacturing and regulatory processes, and the third edition of the text provides timely updates for those in this rapidly growing field.

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition

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

Microencapsulation

Author: Simon Benita
Publisher: CRC Press
ISBN: 9781420027990
Format: PDF, Docs
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Presenting breakthrough research pertinent to scientists in a wide range of disciplines-from medicine and biotechnology to cosmetics and pharmacy-this Second Edition provides practical approaches to complex formulation problems encountered in the development of particulate delivery systems at the micro- and nano-size level. Completely revised and expanded to represent the most up-to-date studies in the field, this guide covers advances in pulsatile delivery systems, injectable microparticulate systems, and site-specific delivery systems, as well as potential therapeutic applications of nanotechnology.

Oral Drug Absorption

Author: Jennifer B. Dressman
Publisher: CRC Press
ISBN: 9780824702724
Format: PDF
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A practical, hands-on guide for successfully developing oral drug products, this comprehensive reference runs the gamut from theoretical stages of computer-based calculations to practical guidelines for establishing in vitro/in vivo correlations. Coverage details the interrelationship between the physiology of the gastrointestinal tract and oral drug formulations and absorption, and progresses to the latest applications of pharmacokinetic analysis. Includes chapters by the innovators of the Biopharmaceutical Classification Scheme (BCS), human perfusions, and biorelevant dissolution testing! With over 600 literature references, equations, drawings, and photographs, Oral Drug Absorption offers multiple methods for predicting permeability, solubility, and dissolution for oral bioavailability and bioequivalence facilitates selection of appropriate drug candidates for development fully elaborates on the experimental and data analysis techniques of in vitro/in vivo correlations provides guidance to the Federal Drug Administration's BCS and its applications appends helpful case studies to the concepts discussed and much more! Contributions by more than 20 international specialists on the latest research make Oral Drug Absorption an invaluable tool and useful reference in the hands of pharmaceutical scientists, medicinal chemists, pharmacists, pharmacologists, toxicologists, biochemists, gastroenterologists, regulatory personnel, and graduate school students in these disciplines.

Pharmaceutical Stress Testing

Author: Steven W. Baertschi
Publisher: CRC Press
ISBN: 1439801800
Format: PDF, ePub, Docs
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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).

Sterile Drug Products

Author: Michael J. Akers
Publisher: CRC Press
ISBN: 1420020560
Format: PDF, ePub, Mobi
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Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

Preclinical Drug Development

Author: Mark C. Rogge
Publisher: CRC Press
ISBN: 9781574448825
Format: PDF, ePub, Mobi
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This reference discusses in detail the broad realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology through the regulatory expectations that support clinical trials. Providing chapters on pharmacokinetics, modeling and simulation, formulation and routes of administration, toxicity evaluations, the assessment of drug absorption and metabolism, and interspecies scaling, this guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.

Handbook of Bioequivalence Testing

Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 9780849383595
Format: PDF, ePub, Mobi
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As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete description of every aspect of bioequivalence testing. Features: Describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations Discusses worldwide regulatory requirements for filing for approval of generic drugs Covers GLP, GCP, and 21 CFR compliance requirements for qualifying studies for regulatory submission and facility certification Includes actual examples of reports approved by regulatory authorities to illustrate various scientific, regulatory, and formatting aspects Provides a list of vendors for the software used to analyze bioequivalence studies and recommendations Explains how to apply for a waiver, how to secure regulatory approval of reports, and how to obtain regulatory certification of facilities conducting bioequivalence studies