Mikkael A. Sekeres

Drugs and the FDA

Safety, Efficacy, and the Public's Trust

• Broschiertes Buch

Produktbeschreibung

"The tension between the drugs patients need & what is necessary to demonstrate safety & efficacy; a story of hope in justifiably desperate patients vs. the time it takes to prove drugs actually work"--]cProvided by publisher.

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Produktdetails

• Verlag: MIT Press Ltd
• Seitenzahl: 320
• Erscheinungstermin: 6. Februar 2024
• Englisch
• Abmessung: 219mm x 142mm x 24mm
• Gewicht: 416g
• ISBN-13: 9780262548397
• ISBN-10: 0262548399
• Artikelnr.: 68278985

Autorenporträt

Mikkael A. Sekeres is Professor of Medicine and Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, and former Chair of the Oncologic Drugs Advisory Committee of the FDA. A regular contributor to the Well section of the New York Times, he is the author of When Blood Breaks Down: Life Lessons from Leukemia (MIT Press).

Inhaltsangabe

Preface ix
1 This Little Drug Came to Market... 1
2 And Finally, Efficacy 29
3 The Moxie to Do Battle 53
4 Trials and Tribulations 77
5 Starve a Tumor, Feed an Industry 107
6 A Viral Scourge 131
7 Silence = Death 155
8 The FDA Makes Its Case 185
9 The Avastin Decision 215
Epilogue 247
Acknowledgments 259
Appendix 261
Notes 267
Index 299