Overview
- Fills a niche in pharmaceutical development for start up companies
- Can be used with or without a software application as a paper based system
- Potentially reduces costs and increases effectiveness
Part of the book series: SpringerBriefs in Pharmaceutical Science & Drug Development (BRIEFSPSDD)
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Table of contents (8 chapters)
Keywords
About this book
Authors and Affiliations
About the author
Dr. Catalano has over 37 years of experience in the pharmaceutical industry including positions such as Research Scientist, Group Leader Section Head, Associate Director ,Director ,Senior Director, and Consultant. He has managed the analytical support of Drug Substance and Drug Products, Pharmaceutical Development, Process Chemistry, Stability ,Assessment and Quality Assurance ( GMP, GLP, GCP ). His experience includes classical chemical and instrumental analyses, including MS hyphenated techniques such as GC/LC/MS, Solid State testing methodology and a thorough knowledge of cGMP’s, GLP’s, ICH guidance’s, USP, NF, and other global compendia/guidance’s. His leadership of several Global Pharmaceutical Sciences Teams for development projects involved directing the preparation of CMC documentation such as, IND, DMF, NDA, CTX, INDS, etc. for inclusion into regulatory documents, significant contributions to the registration of several currently marketed products e.g.Celebrex, Bextra, Dynastat, Inspra , Cytotec, Nutrasweet, Arthrotec, and the CMC CTD Global registration submission and approval for Telavancin ( Vibativ ) a peptide antibiotic. His academic work includes an adjunct professorship at St. John's University, College of Pharmacy and Allied Health Professions.
Bibliographic Information
Book Title: Application of Project Management Principles to the Management of Pharmaceutical R&D Projects
Authors: Thomas Catalano
Series Title: SpringerBriefs in Pharmaceutical Science & Drug Development
DOI: https://doi.org/10.1007/978-3-030-57527-4
Publisher: Springer Cham
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2020
Softcover ISBN: 978-3-030-57526-7Published: 06 November 2020
eBook ISBN: 978-3-030-57527-4Published: 05 November 2020
Series ISSN: 1864-8118
Series E-ISSN: 1864-8126
Edition Number: 1
Number of Pages: XV, 70
Number of Illustrations: 19 b/w illustrations, 10 illustrations in colour
Topics: Pharmaceutical Sciences/Technology, Pharmacology/Toxicology, Biomedicine, general, Theoretical and Computational Chemistry, Project Management