Contract Research and Development Organizations-Their History, Selection, and Utilization
Springer International Publishing (Verlag)
978-3-030-43075-7 (ISBN)
This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics:
· The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went.
· Study directors and principal investigators.
· The nuts and bolts of study performance.
· Electronic reporting requirements - SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions).
· Consultants and their roles.
· An expanded examination of common problems and their solutions.
This book boastscomplete directories to the global universe of operating labs - where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities - and for auditing studies and projects at such facilities - are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves.
In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide tothe global industry and this volume provides a complete update.lt;p>Dr. Shayne Gad has o ver 43 years experience as a toxicologist, statistical consultant, manager and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is experienced in occupational and industrial toxicology, development programs (both preclinical and clinical) and study design, conduct and reporting, in evaluating clinical and product safety data, in training and managing staff; in dealing with a wide range of U.S. and foreign regulatory bodies, commercial concerns, and contract research organizations; in labeling and other FDA and EMA compliance issues for drugs, devices and dietary supplements; identifying, developing and putting into everyday use new technology; in writing reports, position papers, Safety Data Sheets, MAA/PLA/IND/NDA/PNA toxicology and pharmacokinetic summaries and package inserts; in preparing and maintaining INDs, MMFs, NDAs , DMFs, IDEs and 510(k)s; in preparing labels and package inserts for drugs, devices, combination products and consumer products; in presentations to FDA and in designing experiments, designing and executing surveys; in the pharmacokinetic and statistical analysis of both experimental and clinical data; in risk assessment; in Proposition 65 assessments and labeling; in the registration of OTC, dietary supplement, nutraceutical, and sterilant products with FDA; and in the development and production of biologic products. This is his 52nd published book.
Introduction.- History of CROs: Including CRO Snapshots and a CRO Genealogy Chart.- The Pharmaceutical Development Process & Testing Requirements.- The Medical Device Development Process & Testing Requirements.- Functions and Types of CROs.- Labs in China and India.- Selection of CROs.- Study Directors and PIs.- Nuts and Bolts of Study Performance SCG/CBS.- Electronic Reporting Requirements (SEND & eCTD).- Study and Project Monitoring.- Contracting, Pricing, and Cost of Works Performed by CROs.- Consultants and their Role.- Building Relationships: Maximizing your return on Expectations with a CRO.- Common Problems and their Solutions.- Appendices: A Toxicology Labs B Medical Device Labs C Phase I Labs D Analytical Labs E GMP Contract Facilities F Formulation G Dosage Forms H Clinical Testing I Regulatory Services J Forms and Checklists.- K Specialized Services.- L Consultants Known to be In-Practice.- Index.
Erscheinungsdatum | 20.07.2021 |
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Zusatzinfo | XIII, 519 p. 19 illus., 1 illus. in color. |
Verlagsort | Cham |
Sprache | englisch |
Maße | 148 x 210 mm |
Gewicht | 687 g |
Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
Medizin / Pharmazie ► Pharmazie ► PTA / PKA | |
Schlagworte | cros • evolving drug research • medical device development outsourcing • Pharmaceutical and medical device Product Development • Pharmaceutical consultants • Pharmaceutical contract research • pharmaceutical outsourcing |
ISBN-10 | 3-030-43075-8 / 3030430758 |
ISBN-13 | 978-3-030-43075-7 / 9783030430757 |
Zustand | Neuware |
Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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