Breadcrumbs Section. Click here to navigate to respective pages.
Book
Book
New Drug Approval Process
DOI link for New Drug Approval Process
New Drug Approval Process book
New Drug Approval Process
DOI link for New Drug Approval Process
New Drug Approval Process book
Get Citation
ABSTRACT
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include:advances in international regulatory requirements, including ICH guidelines and harmonizationa step-by-step
TABLE OF CONTENTS
part Part I|74 pages
Administrative Guidelines for New Product Development
chapter 3|6 pages
Data Presentation for Global Submissions: Text and Tabular Exposition—CTD Format
chapter 4|13 pages
Technology Change—Enabling Clinical Research and Drug Development Processes
part Part II|226 pages
Global Regulatory Submission of Drugs, Biologics and Devices for New Product Approval
chapter 7|35 pages
Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology
chapter 8|35 pages
The Investigational New Drug Application (IND), the Investigational Medicinal Product Dossier (IMPD) and the Investigator's Brochure (IB)
chapter 9|21 pages
New Product Applications for Global Pharmaceutical Product Approvals: U.S. NDA Vs. Global CTD Formats
chapter 10|14 pages
Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs)
chapter 11|39 pages
The CTD and eCTD for the Registration of Pharmaceuticals for Human Use
chapter 13|25 pages
Chemistry, Manufacturing, and Control (ICH Quality Guidelines)
part Part III|138 pages
Developing Clinical Research Trials
chapter 17|16 pages
Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials
chapter 18|11 pages
HIPAA: A New Requirement to the Clinical Study Process
chapter 19|24 pages
Adverse Events and Reactions: Etiology, Drug Interactions, Collection, and Reporting
chapter 20|17 pages
Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions
chapter 21|9 pages
CFR/ICH/EU GCP Obligations of Investigators, Sponsors, and Monitors
part Part V|69 pages
Specific Areas of New Product Submissions
