An Introduction to Regulatory Drug Analysis PDF Download
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Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Drug adulteration
Languages : en
Pages : 0
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Book Description
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Drug adulteration
Languages : en
Pages : 0
Get Book Here
Book Description
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Drug adulteration
Languages : en
Pages : 46
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Book Description
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category :
Languages : en
Pages : 51
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Book Description
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category :
Languages : en
Pages : 51
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Book Description
Author: Mark P. Mathieu
Publisher: Omec
ISBN:
Category : Medical
Languages : en
Pages : 216
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Book Description
Author: Javed Ali
Publisher: Academic Press
ISBN: 0128222239
Category : Medical
Languages : en
Pages : 287
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Book Description
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Drug adulteration
Languages : en
Pages : 64
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Book Description
Author: Daniel Banes
Publisher:
ISBN:
Category : Drug adulteration
Languages : en
Pages : 172
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Book Description
Author: Center for Drug Evaluation and Research (U.S.)
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 64
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Book Description
Author: Behnam Davani
Publisher: John Wiley & Sons
ISBN: 1119121116
Category : Science
Languages : en
Pages : 256
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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.
