FDA's Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions
Author:   Tom Brody (Contract Researcher, Baker Hostetler, San Francisco, CA, USA)
Publisher:   Elsevier Science Publishing Co Inc
ISBN:  

9780128146477


Pages:   656
Publication Date:   20 December 2017
Format:   Paperback
Availability:   Not yet available   Availability explained
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FDA's Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions


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Author:   Tom Brody (Contract Researcher, Baker Hostetler, San Francisco, CA, USA)
Publisher:   Elsevier Science Publishing Co Inc
Imprint:   Academic Press Inc
ISBN:  

9780128146477


ISBN 10:   0128146478
Pages:   656
Publication Date:   20 December 2017
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Forthcoming
Availability:   Not yet available   Availability explained
This item is yet to be released. You can pre-order this item and we will dispatch it to you upon its release.

Table of Contents

1. Introduction2. FDA's decision-making process when assessing ambiguous data3. Food effect studies4. Dose modification and dose titration5. Contraindications6. Animal studies7. Drug-drug interactions -- Part One (small molecule drugs)8. Drug-drug interactions -- Part Two (therapeutic proteins)9. Immunosuppression, drug-induced hypersensitivity reactions, and drug-induced autoimmune reactions10. Drug class analysis11. Relatedness12. Adjudication of clinical data13. Coding14. Pooling

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