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Lectures on Numerical Methods in Bifurcation Problems
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Occupiers of Wall Street: Losers or Game Changers
The Solution of the Pyramid Problem
Lectures on Moduli of Curves
Walden by Henry David Thoreau
Methods for Finding Zeros in Polynomials
Lectures on Stochastic Flows and Applications
Educational Psychology by Edward L. Thorndike
The Last Days of Tolstoy by V. G. Chertkov
Globalization and Responsibility
Lectures on Siegel Modular Forms and Representation by Quadratic Forms
Lectures on Topics In One-Parameter Bifurcation Problems
History of the Incas by Pedro Sarmiento de Gamboa
Linear Algebra: Theorems and Applications
Lectures on Stochastic Differential Equations and Malliavin Calculus
A Short Biographical Dictionary of English Literature
Lectures on Sieve Methods and Prime Number Theory
Dollars and Sense by William Crosbie Hunter
The Theory of the Theatre by Clayton Hamilton
The Mathematics of Investment
Occupiers of Wall Street: Losers or Game Changers
The Solution of the Pyramid Problem
Lectures on Moduli of Curves
Walden by Henry David Thoreau
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Clinical Drug Trials and Tribulations Second Edition
Posted on 2010-04-14
|
edited by Allen Cato,Lynda Sutton and Allen Cato III 368 pages - 2 edition (March 26, 2002) ISBN: 0824703146 – Pdf - Size: 3,7Mb Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations 2nd Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. New to the Second Edition: • international regulation and deregulation • venture capitalist investment • the IND process • informed consent • changes in manufacturing and updated and extended coverage of: • pediatric drug trial design • the advantages and disadvantages of orphan drug designations • the maximization of package inserts for marketing • post approval safety surveillance • withdrawals from the drug market Clinical Drug Trials and Tribulations will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research. Contents 1. Current Challenges and Future Directions of Drug Development 2. Preclinical Drug Discovery and Development 3. The IND Process for New Drug Products 4. Performance and Interpretation of Laboratory Tests 5. Issues in Endpoint Selection 6. Dix, Cent, Mille: Proof of Principle with $10 Million, 100 Patients, and 1000 Days 7. Clinical Drug Trials in Pediatrics: Dilemmas of Clinical Drug Trials in Pediatric Populations 8. Electronic Capture of Clinical Trial Information 9. Providing Patient Access to Promising Investigational Drugs 10. Issues in the Review of Clinical Drug Trials by IRBs 11. Personal Care and Randomized Clinical Trials: Understanding the Ethical Conflicts 12. Informed Consent in Clinical Trials: Emerging Issues 13. Orphan Drug Development: David and Goliath 14. Single-Event Adverse Drug Reactions: Tribulations in Ascribing Causality 15. How to Deal with a Sudden, Unexpected Death in Clinical Studies 16. Clinical Trial Material�The Fuel for Clinical Research 17. The Role of Pharmacokinetics in Drug Development 18. Building an NDA/BLA 19. International Planning of Drug Clinical Trials 20. Uncertainty in Drug Development: Approval Success Rates for New Drugs 21. Contract Clinical Research: Value to In-House Drug Development 22. Package Inserts as Viewed by the Busy Private Practitioner 23. New Directions in Pharmaceutical Promotion: Regulatory Concerns and Contrivances 24. The Campus Researcher and Industry: Issues of Intellectual Property and Technology Transfer 25. Anatomy of Drug Withdrawals in the United States Appendices: Routine Clinical Analyte Test Results Index link: http://rapidshare.de/files/30119757/CDTaT2.rar
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