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REPORT

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Pharm Med 2011; 25 (6): 415-424 1178-2595/11/0006-0415/$49.95/0

ª 2011 Adis Data Information BV. All rights reserved.

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Contents 1. Biosimilars of Biological Drug Therapies: Regulatory, Clinical and Commercial Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions: A Review of 198 Submissions Between 2000 and 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Vaccination Strategies in Lymphomas and Leukaemias: Recent Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. New Approaches to the Treatment of Pancreatic Cancer: From Tumor-Directed Therapy to Immunotherapy . . . . . . . . . . . . . . . . . 5. Early Assessment of Medical Technologies to Inform Product Development and Market Access: A Review of Methods and Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6. Is the Large Simple Trial Design Used for Comparative, Post-Approval Safety Research? A Review of a Clinical Trials Registry and the Published Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7. Glucagon-like Peptide-1 Analogues for Type 2 Diabetes Mellitus: Current and Emerging Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8. Pharmacological Modulation of Arterial Stiffness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9. Development of an AS04-Adjuvanted HPV Vaccine with the Adjuvant System Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10. The Application of Delivery Systems for DNA Methyltransferase Inhibitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11. A Review of the Costs and Cost Effectiveness of Interventions in Chronic Kidney Disease: Implications for Policy . . . . . . . . . . . . . . . 12. Cautions Regarding the Fitting and Interpretation of Survival Curves: Examples from NICE Single Technology Appraisals of Drugs for Cancer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13. Fluoroquinolone-Associated Myasthenia Gravis Exacerbation: Evaluation of Postmarketing Reports from the US FDA Adverse Event Reporting System and a Literature Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14. Drug-Induced Taste and Smell Alterations: A Case/Non-Case Evaluation of an Italian Database of Spontaneous