Front  |   Who are we  |   News |   Teaching  |   Investigation  |   Labor exchange  |   Congresses and courses  |   Links  |   Bibliography  
Front> Bibliography> Pharmaceutical technology, Biodrugstore
New drug approval process: accelerating global registrations
Author: Guarino, Richard A.
 ISBN: 0-8247-5041-1
Pharmaceutical industry professionals unturn in the clinical, regulatory, statistical, and legal development of new drugs, ace well expert pharmacists, pharmacologists, clinical investigators, and graduate and upper-level undergraduate students who intend to pursue careers in the pharmaceutical industry. PARTIAL CONTENTS
Regulatory Practices and Procedures of New Drug, Biologics and Device Development
New Product Development Teams Duane B. Lakings
Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology Duane B. Lakings
The Investigational New Drug Application (IND) and the Investigatorfs Brochure (IB) @William M. Troetel
Clinical Research Development
Clinical Research Protocols Richard A. Guarino
Adverse Experiences, Adverse Reactions and Interactions of Drugs Richard A. Guarino
Statistical and Data Management Collaboration in Clinical Research

Mark Bradshaw and Lawrence A. Meinert
Specific Aspects in the Process of New Product Submissions
Chemistry, Manufacturing and Control (CMC) Requirements of the NDA and ANDA Evan Siegel
Byline Presentation for FDA Submissions: Text and Tabular Exposition Patricia Blaine
Preparing for FDA Inspections: Manufacturing Site Timothy Urschel
Global Applications of Good Clinical Practices (GCPs)
Obligations of the Investigator, Sponsor and Monitor Richard A. Guarino
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) and Informed Consent (IC): Protecting Subjects throughout the Clinical Research Process Rochelle L. Goodson
Quality Assurance Earl W. Hulihan
 





If you believe that some link is missing that it could be interesting send it to us
- To recommend a linkage



biopharmabonanza.com

Who are we | Publicity |Trminos and conditions | Privacy | Contact | Sitemap | Home
Copyright (c) 2009 Society Espaoal de Farmacia Industrial and Galnica Developed by more impact Networks


Best site
Live results - nice pics - erotic - ferien Polen - Betting - beinggirl uk