Good Clinical Practices in Pharmaceuticals
Series: Drugs and the Pharmaceutical Sciences;
- Publisher's listprice GBP 99.99
-
47 770 Ft (45 495 Ft + 5% VAT)
The price is estimated because at the time of ordering we do not know what conversion rates will apply to HUF / product currency when the book arrives. In case HUF is weaker, the price increases slightly, in case HUF is stronger, the price goes lower slightly.
- Discount 10% (cc. 4 777 Ft off)
- Discounted price 42 993 Ft (40 946 Ft + 5% VAT)
Subcribe now and take benefit of a favourable price.
Subscribe
47 770 Ft
Availability
Estimated delivery time: In stock at the publisher, but not at Prospero's office. Delivery time approx. 3-5 weeks.
Not in stock at Prospero.
Why don't you give exact delivery time?
Delivery time is estimated on our previous experiences. We give estimations only, because we order from outside Hungary, and the delivery time mainly depends on how quickly the publisher supplies the book. Faster or slower deliveries both happen, but we do our best to supply as quickly as possible.
Product details:
- Edition number 1
- Publisher CRC Press
- Date of Publication 26 November 2024
- ISBN 9781032524078
- Binding Hardback
- No. of pages206 pages
- Size 234x156 mm
- Weight 460 g
- Language English
- Illustrations 6 Illustrations, black & white; 6 Line drawings, black & white; 3 Tables, black & white 725
Categories
Short description:
This book provides a thorough reference on Good Clinical Practice (GCP) which is the international ethical, scientific and practical standard to which all clinical research is conducted.
MoreLong description:
Good clinical practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP assures patients and the public that the rights, safety, and wellbeing of people taking part in studies are protected and that research data is reliable.
- Presents details on GCP, the international ethical, scientific, and practical standard to which all clinical research is conducted.
- Provides the most up‑to‑date and best practices, techniques, and methodologies in good clinical practice.
- Discusses applicable laws and regulations supporting GCP compliance, quality and operations.
- Describes who is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol.
Table of Contents:
Preface
About the Editor
List of Contributors
Introduction
1 Regulatory Application Requirements
Shanthi Ganeshan and Connie Freund
2 An overview of Good Clinical Practices
John Klein and Sonya Edgerton
3 Quality by Design, Critical to Quality Factors - ICH E8 (R1)
Sam Sather and Jennifer Lawyer
4 Good Clinical Practice ICH E6 (R2 and R3)
John Klein and Sonya Edgerton
5 Clinical Safety Data Management ICH E2A
Karen Truhe
6 21 CFR 50 – Informed Consent
Joe Near
7 21 CFR 54 – Financial Disclosure
Glenda Guest
8 21 CFR 56 – Institutional Review Boards
Aurea Flores
9 Protected Health Information and Privacy in Clinical Trials (HIPAA)
Sam Sather
10 Good Pharmacovigilance Practices (GVP)
Jessica Chu
11 Data Integrity and 21CFR11 for GCPs
Randall Basinger
12 Preparing for FDA inspections at sponsor/investigator sites
Tommy Lee and Sam Sather
13 Regulations relating to the Placebo response in Clinical research
Graham Bunn and Arthur Ooghe
