A guide to making the drug-development process more efficient, by way of analyzing various steps in clinical research.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Michael Tansey is former Vice President of La Jolla Pharmaceutical Company. He is currently an R&D consultant to pharmaceutical and biotechnology companies.
Inhaltsangabe
* PART 1: SETTING THE SCENE * Introduction: Cutting the Gordian Knot * Chapter 1: Aiming for Excellence * PART 2: PLANNING: FROM CHAOS TO COSMOS * Chapter 2: The Target Product Profile and Its Uses * Chapter 3: Planning the Individual Clinical Trial * PART 3: THE PRACTICABLE PROTOCOL * Chapter 4. Distilling the Essence of the Protocol: The Protocol Synopsis * Chapter 5. Redistillation: Eliminating Impurities By Carrying Out Protocol * Chapter 6. The Optimal Blend: The approved Synopsis and the Final Protocol * PART 4: THE SPONSOR, THE PHYSICIAN AND THE PATIENT; THE ETERNAL CLINICAL TRIAL TRIANGLE * Chapter 7: Of Chickens and Eggs: The Sponsors' Dilemma * Chapter 8: Clinician or Clinical Trialist: the Physicians' Dilemma * Chapter 9: what About the Customer? the Patients' Dilemma * PART 5: AND ANOTHER THING... * Chapter 10: About Time: Making Meetings Matter * Chapter 11: The Brain-Scrambling, Fit-Inducing, Mind-Numbing Technicolor
* PART 1: SETTING THE SCENE * Introduction: Cutting the Gordian Knot * Chapter 1: Aiming for Excellence * PART 2: PLANNING: FROM CHAOS TO COSMOS * Chapter 2: The Target Product Profile and Its Uses * Chapter 3: Planning the Individual Clinical Trial * PART 3: THE PRACTICABLE PROTOCOL * Chapter 4. Distilling the Essence of the Protocol: The Protocol Synopsis * Chapter 5. Redistillation: Eliminating Impurities By Carrying Out Protocol * Chapter 6. The Optimal Blend: The approved Synopsis and the Final Protocol * PART 4: THE SPONSOR, THE PHYSICIAN AND THE PATIENT; THE ETERNAL CLINICAL TRIAL TRIANGLE * Chapter 7: Of Chickens and Eggs: The Sponsors' Dilemma * Chapter 8: Clinician or Clinical Trialist: the Physicians' Dilemma * Chapter 9: what About the Customer? the Patients' Dilemma * PART 5: AND ANOTHER THING... * Chapter 10: About Time: Making Meetings Matter * Chapter 11: The Brain-Scrambling, Fit-Inducing, Mind-Numbing Technicolor
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