Specification of Drug Substances and Products

Produk Detail:
  • Author : Christopher M. Riley
  • Publisher : Elsevier Science Limited
  • Pages : 380 pages
  • ISBN : 9780080983509
  • Rating : /5 from reviews
CLICK HERE TO GET THIS BOOK >>>Specification of Drug Substances and Products

Download or Read online Specification of Drug Substances and Products full in PDF, ePub and kindle. this book written by Christopher M. Riley and published by Elsevier Science Limited which was released on 01 September 2013 with total page 380 pages. We cannot guarantee that Specification of Drug Substances and Products book is available in the library, click Get Book button and read full online book in your kindle, tablet, IPAD, PC or mobile whenever and wherever You Like. Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD) Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authorities Direct applicability to the day-to-day activities in drug development and the potential to increase productivity

Specification of Drug Substances and Products

Specification of Drug Substances and Products
  • Author : Christopher M. Riley,Thomas W. Rosanske,Shelley R. Rabel Riley
  • Publisher : Elsevier Science Limited
  • Release : 01 September 2013
GET THIS BOOK Specification of Drug Substances and Products

Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and

Specification of Drug Substances and Products

Specification of Drug Substances and Products
  • Author : Christopher M. Riley,Thomas W. Rosanske,George L. Reid
  • Publisher : Elsevier
  • Release : 23 July 2020
GET THIS BOOK Specification of Drug Substances and Products

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life

Specification of Drug Substances and Products

Specification of Drug Substances and Products
  • Author : Christopher M. Riley,Thomas W. Rosanske,Shelley R. Rabel Riley
  • Publisher : Elsevier
  • Release : 01 June 2016
GET THIS BOOK Specification of Drug Substances and Products

"Specification of Drug Substances and Products: Development and Validation of Analytical Methods" is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and

Pharmaceutical Analysis for Small Molecules

Pharmaceutical Analysis for Small Molecules
  • Author : Behnam Davani
  • Publisher : John Wiley & Sons
  • Release : 14 August 2017
GET THIS BOOK Pharmaceutical Analysis for Small Molecules

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

The Rules Governing Medicinal Products in the European Community Guidelines on the quality safety and efficacy of medicinal products for human use

The Rules Governing Medicinal Products in the European Community  Guidelines on the quality  safety and efficacy of medicinal products for human use
  • Author : Anonim
  • Publisher : Unknown
  • Release : 15 June 1989
GET THIS BOOK The Rules Governing Medicinal Products in the European Community Guidelines on the quality safety and efficacy of medicinal products for human use

EEC regulations for the marketing, production, and distribution of pharmaceutical products to safeguard public health. Also includes the controls on manufacturing and labeling of drugs.

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Herbal Medicinal Products
  • Author : Frauke Gaedcke,Barbara Steinhoff,Helga Blasius
  • Publisher : Unknown
  • Release : 15 June 2021
GET THIS BOOK Herbal Medicinal Products

European legislation requires herbal medicinal products (HMPs) to meet strict standards of quality, safety and efficacy. In Europe and worldwide, HPMs play an important role both in self-medication and in medical practice. Book jacket.