drug products for clinical trials second edition drugs and the pharmaceutical sciences

Download Book Drug Products For Clinical Trials Second Edition Drugs And The Pharmaceutical Sciences in PDF format. You can Read Online Drug Products For Clinical Trials Second Edition Drugs And The Pharmaceutical Sciences here in PDF, EPUB, Mobi or Docx formats.

Drug Products For Clinical Trials Second Edition

Author : Donald Monkhouse
ISBN : 9780824754624
Genre : Medical
File Size : 43. 42 MB
Format : PDF, Docs
Download : 934
Read : 651

Get This Book


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
ISBN : 9781420084733
Genre : Medical
File Size : 41. 73 MB
Format : PDF, ePub, Docs
Download : 384
Read : 152

Get This Book


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
ISBN : 9781118210703
Genre : Science
File Size : 88. 71 MB
Format : PDF, Docs
Download : 500
Read : 336

Get This Book



New Drug Development

Author : J. Rick Turner
ISBN : 1441964185
Genre : Medical
File Size : 26. 40 MB
Format : PDF, ePub, Docs
Download : 873
Read : 882

Get This Book


New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.

Protein Formulation And Delivery Second Edition

Author : Eugene J. McNally
ISBN : 0849379520
Genre : Medical
File Size : 31. 20 MB
Format : PDF, Mobi
Download : 199
Read : 743

Get This Book


This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytical methods, and an overview of the drug substance manufacturing process. Preformulation and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery and non-traditional formulations are also addressed. Because many developments in the field have emerged since the publication of the First Edition, this Second Edition addresses important new patient-friendly developments in the field, such as formulation for implantable devices, needle-free formulation and delivery approaches, and oral delivery of proteins.

Pharmaceutical Stress Testing

Author : Steven W. Baertschi
ISBN : 9781439801802
Genre : Medical
File Size : 28. 4 MB
Format : PDF, ePub, Mobi
Download : 208
Read : 1286

Get This Book


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).

Clinical Drug Trials And Tribulations Revised And Expanded Second Edition

Author : Allen Cato
ISBN : 9780824744809
Genre : Medical
File Size : 63. 13 MB
Format : PDF, Docs
Download : 665
Read : 597

Get This Book


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.

Oral Drug Absorption

Author : Jennifer B. Dressman
ISBN : 0824702727
Genre : Medical
File Size : 53. 78 MB
Format : PDF, Docs
Download : 102
Read : 735

Get This Book


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.

Sterile Drug Products

Author : Michael J. Akers
ISBN : 9781420020564
Genre : Medical
File Size : 46. 86 MB
Format : PDF, Mobi
Download : 590
Read : 221

Get This Book


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
ISBN : 157444882X
Genre : Medical
File Size : 30. 65 MB
Format : PDF
Download : 391
Read : 1324

Get This Book


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.

Top Download:

Best Books