£57.99

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Basic Concepts in Regulatory Affairs: Basic Protocols

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Price History & Forecast

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Last 70 days · 70 data points (no recent data)

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£62.98 £57.49 £58.69 £59.89 £61.08 £62.28 £63.48 25 July 2026 11 August 2026 28 August 2026 14 September 2026 02 October 2026
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Price Distribution

Price distribution over 70 days • 2 price levels

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Current Price
59 days · current 11 days 0 15 30 44 59 £58 £63 Days at Price

Price Analysis

Most common price: £58 (59 days, 84.3%)

Price range: £58 - £63

Price levels: 2 different prices over 70 days

Description

"Regulatory Affairs: Basic Protocols" provides a comprehensive guide to the basic concepts and protocols in the pharmaceutical industry. Written in a clear and concise manner, this book covers topics including documentation, chemistry, manufacturing, and controls, as well as the investigation of medicinal product dossier and the development of clinical trial protocols. Throughout the book, readers will learn about the concept of innovator and generic drugs, drug development, and the regulatory guidance and guidelines for filing and approval. This book also explores the preparation of dossiers and their submission to regulatory agencies in different countries, as well as post-approval regulatory requirements for actives and drug products. Readers will also gain valuable insights into the submission of global documents in CTD/eCTD formats, clinical trial requirements for approvals for conducting clinical trials, pharmacovigilance, and the process of monitoring clinical trials. "Regulatory Affairs: Basic Protocols" is an indispensable resource for anyone looking to gain a deeper understanding of the regulatory affairs landscape in the pharmaceutical industry. With clear descriptions, helpful figures, and illustrative examples, this book will make the subject more accessible and interesting for any reader.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
09 February 2023
Listed Since
20 January 2025

Barcode

No barcode data available

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