International Pharmaceutical Product Registration: 200 (Drugs and the Pharmaceutical Sciences) - Image 1

Price loading...

CRC Press International Pharmaceutical Product Registration: 200 (Drugs and the Pharmaceutical Sciences)

Name: International Pharmaceutical Product Registration: 200 (Drugs and the Pharmaceutical Sciences)
Brand: CRC Press

Pharmacy - Dispensing

Price History & Forecast

No Price Data Available

Price history will appear here once data is collected from Amazon.

Price Distribution

No price data available for histogram

Description

Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update. This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed. The book is organized into six highly practical segments: Part I: CTD, eCTD, Module 1, and Environmental Risk Assessment Part II: CTD Summaries Part III: Quality Topics Part IV: Nonclinical Topics Part V: Clinical Topics Part VI: Other Topics (including drug-device combination products) This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.

Product Specifications

Brand: CRC Press
Format: hardcover
ASIN: 1420081764
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain: Amazon UK
Release Date: 26 August 2009
Listed Since: 17 January 2008

Barcode

No barcode data available

CRC Press International Pharmaceutical Product Registration: 200 (Drugs and the Pharmaceutical Sciences)

Price History & Forecast

No Price Data Available

Price Distribution

Description

Product Specifications

Barcode

Similar Products You Might Like

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

Generic Drug Product Development: International Regulatory Requirements for Bioequivalence: 201 (Drugs and the Pharmaceutical Sciences)

Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation, Second Edition: 205 (Drugs and the Pharmaceutical Sciences)

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Generic Drug Product Development: International Regulatory Requirements for Bioequivalence (Drugs and the Pharmaceutical Sciences, 201)

Regulatory Affairs in the Pharmaceutical Industry

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective

Development and Evaluation of Drugs: From Laboratory through Licensure to Market

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Technology Transfer: Drug Product Manufacturing Process: 10 (AAPS Introductions in the Pharmaceutical Sciences, 10)

Springer - Contract Research and Development Organizations Book

Contract Research and Development Organizations-Their History, Selection, and Utilization

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products: 2

Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition: 129 (Drugs and the Pharmaceutical Sciences)

The Pharmaceutical Regulatory Process: 185 (Drugs and the Pharmaceutical Sciences)

Pharmaceutical Dosage Forms: Parenteral Medications: 003

Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

Specification of Drug Substances and Products: Development and Validation of Analytical Methods

CRC Press Measuring Elemental Impurities in Pharmaceuticals

Specification of Drug Substances and Products: Development and Validation of Analytical Methods