[Book] Management and Assurance of Data Used in Drug Approval Applications with eCTD and CDISC (No. 1987BOD)
TECHNICAL INFOMATION INSTITUTE CO.,LTD
■ Table of Contents (Excerpt) Chapter 1: SEND Application and Raw Data from Non-Clinical Trials Chapter 2: Application Data Compliant with CDISC Chapter 3: Practical Response to eCTD Applications Chapter 4: Ensuring the Reliability of Application Data for Manufacturing and Marketing Approval Chapter 5: Management Leading to Manufacturing and Marketing Approval Applications Chapter 6: Digitization and Operation of Clinical Trial-Related Documents Chapter 7: Writing Methods for Biopharmaceutical Manufacturing and Marketing Approval Applications Chapter 8: CTD Writing Methods Chapter 9: Description of Manufacturing Methods Chapter 10: Compliance Investigations and Overseas GCP Inspection Cases Chapter 11: Obtaining Reliable Application Data Chapter 12: Other Considerations for Pharmaceutical Approval Applications －－－－－－－－－－－－－－－－－－－－－－－－－－ ● Published: March 29, 2019 ● Authors: 57 ● Format: A4 Size, 628 Pages Hardcover Edition: Price: 88,000 yen (tax included) ISBN: 978-4-86104-741-1 ↓↓ The hardcover edition is out of print ↓↓ On-Demand Edition Available Price: 44,000 yen (tax included) ISBN: 978-4-86104-965-1 After receiving your order, we will perform simple printing and binding. －－－－－－－－－－－－－－－－－－－－－－－－－－
