The thoroughly revised Fifth edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.
Updated chapters include:
Part I: Administartive Guidelines for New Product Development
Part II: Global Regulatory Submission of Drugs, Biologics and Devices for New Product Approval
Part III: Developing Clinical Research Trials
Part IV: Global Regulations for Good Clinical Practices (GCP)
Part V: Specific Areas of New Product Submissions
Acronyms and Initialisms
Divided into the three main sections of synthesis, analysis and drug development, this handbook covers all stages of the drug development process, including large-scale synthesis and purification of chirally pure pharmaceuticals.
Chirality in Drug Research Eric Francotte (Editor), Wolfgang Lindner (Editor), Raimund Mannhold (Series Editor), Hugo Kubinyi (Series Editor), Gerd Folkers (Series Editor)370 pages
Destined to become every regulatory director's essential desktop companion
rofessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.
Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines.
As well, vital information is provided on the most common types of submissions, including:
Orphan Drug Applications
Investigatory New Drug Applications (INDAs)
New Drug Applications (NDAs)
Abbreviated New Drug Applications (ANDAs)
This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia.
Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.
Chapter 2. FDA Meeting Requests.
Chapter 3. Orphan Drug Applications.
Chapter 4. Investigatory New Drug Applications (INDs).
Chapter 5. New Drug Applications (NDAs).
Chapter 6. 505(b)2 New Drug Applications.
Chapter 7. Abbreviated New Drug Applications (ANDAs).
Chapter 8. Annual Reports.
Chapter 9. International Submissions (Carl A. Rockburne).
Chapter 10. Future Issues in Regulatory Submissions.
SANDY WEINBERG is the former Vice President for Regulatory Affairs and Quality Assurance at Tikvah Therapeutics, Inc., and is now Associate Professor of Health Care Management and Director of the Master in Health Administration Graduate Program at Clayton State University in Atlanta. He has thirty years of experience in the field of drug regulatory affairs and is the author of twelve books, most recently Good Laboratory Practice Regulations, Fourth Edition.
Martindale's Complete Drug Reference is the foremost source for medicines information worldwide and also includes details on herbal medicines.
When you purchase this new two-volume set, 37th edition, you will receive the full book and digital package, consisting of the two volume reference book in a sturdy slip case, plus one year's individual access to the online version of Martindale via MedicinesComplete, with all the attendant benefits, including updating every 90 days. Purchasers will have the opportunity to renew their online access at substantially discounted rates.
Martindale's Complete Drug Reference provides reliable, unbiased and independently evaluated information on drugs and medicines used throughout the world—no other source has this breadth and depth of coverage. It is a comprehensive source of information on drugs and other substances of interest to pharmacists and medical practitioners.
In addition to encyclopedic information on drugs used clinically, it also includes veterinary and investigational drugs, other compounds used in medicine, pharmaceutical excipients, herbal medicines, toxic substances, and more.
Martindale The Complete Drug Reference 37th edition provides reliable, unbiased and evaluated information on drugs and medicines used throughout the world—no other source has the breadth and depth of coverage.
New for the 37th edition:
Published Jun 2014Hardback, 2 volumes
Martindale: The Complete Drug Reference provides reliable, unbiased and evaluated information on drugs and medicines used throughout the world. Based on published information and extensively referenced, Martindale develops as the body of knowledge on existing drugs grows. The most clinically relevant and appropriate information is evaluated and selected from reliable published sources.
This package contains two hardback volumes presented in a slipcase with:
Improvements to the 38th edition of Martindale include:
The development of suitable assays, the integration of appropriate technology, and the effective management of the essential infrastructure are all critical to the success of any high-throughput screening (HTS) endeavor. However, few scientists have the multidisciplinary experience needed to control all aspects of an HTS drug discovery project. A Practical Guide to Assay Development and High-Throughput Screening in Drug Discovery integrates the experience of diverse experts who offer fundamental and practical guidance across numerous situations.
The book first discusses assay developments for important target classes such as protein kinases and phosphatases, proteases, nuclear receptors, G protein-coupled receptors, ion channels, and heat shock proteins. It next examines assay developments for cell viability, apoptosis, and infectious diseases. The contributors explore the application of emerging technologies and systems, including image-based high content screening, RNA interference, and primary cells. Finally, they discuss the essential components of the integrated HTS process, such as screening automation, compound library management, the screening of natural products from botanical sources, and screening informatics.
Designed to motivate researchers to bring further advances to the field, this volume provides practical guidance on how to initiate, validate, optimize, and manage a bioassay intended to screen large collections of compounds. Drawing on the knowledge from experts actively involved in assay development and HTS, this is a resource that is both comprehensive and focused.
Table of Contents
Assay Development for Protein Kinases and Phosphatases, J. F. Glickman
Fluorescence-Based Biochemical Protease Assay Formats, J. Woelcke and U. Hassiepen
Assay Development for Nuclear Hormone Receptors, C. Bai and E. N. Johnson
Assay Development for G Protein-Coupled Receptors and Ion Channels, J. G. McGivern, Y. Qian, and P. H. Lee
Assay Development for Heat Shock Proteins, Z. Gao and S. Fong
Assay Development for Cell Viability and Apoptosis for High Throughput Screening, T. L. Riss, R. A. Moravec, and A. L. Niles
Assay Development for Antimicrobial Drug Discovery, H. H. Xu
Image-Based High Content Screening, Y. Feng and C. J. Wilson
Application of RNA Interference in Drug Discovery, N. M. Wolters and J. P. MacKeigan
Assay Development Using Primary and Primary-Like Cells, S. Corazza and E. J. Wade
Screening Automation, W. Zheng and C. Z. Chen
Compound Library Management, D. Nie
Unique Discovery Aspects of Utilizing Botanical Sources, S. P. Manly, T. Smillie, J. P. Hester, I. Khan, and L. Coudurier
Screening Informatics, S. C. Schürer and N. F. Tsinoremas
This versatile guide provides a wide range of information on the composition, utilization, and evaluation of colorants and pigments in food, pharmaceuticals, and cosmetic products.
Tabulates key data for food, drug, and cosmetic colorants by Color Index Number!
Thoroughly describing the relationships between coloring reactions, Coloring of Food, Drugs and Cosmetics
With over 300 tables and drawings, Coloring of Food, Drugs and Cosmetics is suitable for food scientists and technologists; food, cosmetics, pharmaceutical, chemical, agricultural, and biochemical engineers; pharmacists; quality control and assurance managers; biochemists and biotechnologists; and upper-level undergraduate and graduate students in these disciplines.
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