Table of Contents for the Digital Edition of Drug Information Journal - January 2008 Drug Information Journal - January 2008 Table of Contents Introduction: PhRMA’s Best Practices Initiative on FDA’s Good Review Management Practices Best Practices for Communication Between FDA and Applicants During the NDA Review Cycle: A PhRMA White Paper Best Practices for Special Protocol Assessment Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper A PhRMA Survey of Tracking and Reporting of Postmarketing Commitments Vector Analysis to Detect Hepatotoxicity Signals in Drug Development Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions Handbook of Pharmaceutical Public Policy Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints International Symposium on Adaptive Clinical Trial Designs Drug Information Journal - January 2008 Drug Information Journal - January 2008 - (Page Intro) Drug Information Journal - January 2008 - Drug Information Journal - January 2008 (Page Cover1) Drug Information Journal - January 2008 - Drug Information Journal - January 2008 (Page Cover2) Drug Information Journal - January 2008 - Drug Information Journal - January 2008 (Page i) Drug Information Journal - January 2008 - Drug Information Journal - January 2008 (Page ii) Drug Information Journal - January 2008 - Drug Information Journal - January 2008 (Page iii) Drug Information Journal - January 2008 - Drug Information Journal - January 2008 (Page iv) Drug Information Journal - January 2008 - Drug Information Journal - January 2008 (Page v) Drug Information Journal - January 2008 - Drug Information Journal - January 2008 (Page vi) Drug Information Journal - January 2008 - Table of Contents (Page vii) Drug Information Journal - January 2008 - Table of Contents (Page viii) Drug Information Journal - January 2008 - Table of Contents (Page ix) Drug Information Journal - January 2008 - Table of Contents (Page x) Drug Information Journal - January 2008 - Table of Contents (Page xi) Drug Information Journal - January 2008 - Table of Contents (Page xii) Drug Information Journal - January 2008 - Introduction: PhRMA’s Best Practices Initiative on FDA’s Good Review Management Practices (Page 1) Drug Information Journal - January 2008 - Introduction: PhRMA’s Best Practices Initiative on FDA’s Good Review Management Practices (Page 2) Drug Information Journal - January 2008 - Best Practices for Communication Between FDA and Applicants During the NDA Review Cycle: A PhRMA White Paper (Page 3) Drug Information Journal - January 2008 - Best Practices for Communication Between FDA and Applicants During the NDA Review Cycle: A PhRMA White Paper (Page 4) Drug Information Journal - January 2008 - Best Practices for Communication Between FDA and Applicants During the NDA Review Cycle: A PhRMA White Paper (Page 5) Drug Information Journal - January 2008 - Best Practices for Communication Between FDA and Applicants During the NDA Review Cycle: A PhRMA White Paper (Page 6) Drug Information Journal - January 2008 - Best Practices for Communication Between FDA and Applicants During the NDA Review Cycle: A PhRMA White Paper (Page 7) Drug Information Journal - January 2008 - Best Practices for Communication Between FDA and Applicants During the NDA Review Cycle: A PhRMA White Paper (Page 8) Drug Information Journal - January 2008 - Best Practices for Special Protocol Assessment (Page 9) Drug Information Journal - January 2008 - Best Practices for Special Protocol Assessment (Page 10) Drug Information Journal - January 2008 - Best Practices for Special Protocol Assessment (Page 11) Drug Information Journal - January 2008 - Best Practices for Special Protocol Assessment (Page 12) Drug Information Journal - January 2008 - Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper (Page 13) Drug Information Journal - January 2008 - Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper (Page 14) Drug Information Journal - January 2008 - Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper (Page 15) Drug Information Journal - January 2008 - Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper (Page 16) Drug Information Journal - January 2008 - Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper (Page 17) Drug Information Journal - January 2008 - Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper (Page 18) Drug Information Journal - January 2008 - Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper (Page 19) Drug Information Journal - January 2008 - Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper (Page 20) Drug Information Journal - January 2008 - Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper (Page 21) Drug Information Journal - January 2008 - Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper (Page 22) Drug Information Journal - January 2008 - A PhRMA Survey of Tracking and Reporting of Postmarketing Commitments (Page 23) Drug Information Journal - January 2008 - A PhRMA Survey of Tracking and Reporting of Postmarketing Commitments (Page 24) Drug Information Journal - January 2008 - A PhRMA Survey of Tracking and Reporting of Postmarketing Commitments (Page 25) Drug Information Journal - January 2008 - A PhRMA Survey of Tracking and Reporting of Postmarketing Commitments (Page 26) Drug Information Journal - January 2008 - Vector Analysis to Detect Hepatotoxicity Signals in Drug Development (Page 27) Drug Information Journal - January 2008 - Vector Analysis to Detect Hepatotoxicity Signals in Drug Development (Page 28) Drug Information Journal - January 2008 - Vector Analysis to Detect Hepatotoxicity Signals in Drug Development (Page 29) Drug Information Journal - January 2008 - Vector Analysis to Detect Hepatotoxicity Signals in Drug Development (Page 30) Drug Information Journal - January 2008 - Vector Analysis to Detect Hepatotoxicity Signals in Drug Development (Page 31) Drug Information Journal - January 2008 - Vector Analysis to Detect Hepatotoxicity Signals in Drug Development (Page 32) Drug Information Journal - January 2008 - Vector Analysis to Detect Hepatotoxicity Signals in Drug Development (Page 33) Drug Information Journal - January 2008 - Vector Analysis to Detect Hepatotoxicity Signals in Drug Development (Page 34) Drug Information Journal - January 2008 - Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity (Page 35) Drug Information Journal - January 2008 - Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity (Page 36) Drug Information Journal - January 2008 - Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity (Page 37) Drug Information Journal - January 2008 - Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity (Page 38) Drug Information Journal - January 2008 - Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity (Page 39) Drug Information Journal - January 2008 - Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity (Page 40) Drug Information Journal - January 2008 - Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity (Page 41) Drug Information Journal - January 2008 - Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity (Page 42) Drug Information Journal - January 2008 - Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity (Page 43) Drug Information Journal - January 2008 - Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity (Page 44) Drug Information Journal - January 2008 - Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA (Page 45) Drug Information Journal - January 2008 - Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA (Page 46) Drug Information Journal - January 2008 - Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA (Page 47) Drug Information Journal - January 2008 - Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA (Page 48) Drug Information Journal - January 2008 - Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA (Page 49) Drug Information Journal - January 2008 - Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA (Page 50) Drug Information Journal - January 2008 - Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA (Page 51) Drug Information Journal - January 2008 - Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA (Page 52) Drug Information Journal - January 2008 - Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA (Page 53) Drug Information Journal - January 2008 - Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA (Page 54) Drug Information Journal - January 2008 - Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA (Page 55) Drug Information Journal - January 2008 - Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA (Page 56) Drug Information Journal - January 2008 - Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions (Page 57) Drug Information Journal - January 2008 - Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions (Page 58) Drug Information Journal - January 2008 - Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions (Page 59) Drug Information Journal - January 2008 - Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions (Page 60) Drug Information Journal - January 2008 - Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions (Page 61) Drug Information Journal - January 2008 - Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions (Page 62) Drug Information Journal - January 2008 - Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions (Page 63) Drug Information Journal - January 2008 - Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions (Page 64) Drug Information Journal - January 2008 - Handbook of Pharmaceutical Public Policy (Page 65) Drug Information Journal - January 2008 - Handbook of Pharmaceutical Public Policy (Page 66) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 67) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 68) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 69) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 70) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 71) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 72) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 73) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 74) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 75) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 76) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 77) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 78) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 79) Drug Information Journal - January 2008 - Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons (Page 80) Drug Information Journal - January 2008 - On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints (Page 81) Drug Information Journal - January 2008 - On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints (Page 82) Drug Information Journal - January 2008 - On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints (Page 83) Drug Information Journal - January 2008 - On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints (Page 84) Drug Information Journal - January 2008 - On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints (Page 85) Drug Information Journal - January 2008 - On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints (Page 86) Drug Information Journal - January 2008 - On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints (Page 87) Drug Information Journal - January 2008 - On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints (Page 88) Drug Information Journal - January 2008 - On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints (Page 89) Drug Information Journal - January 2008 - On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints (Page 90) Drug Information Journal - January 2008 - On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints (Page 91) Drug Information Journal - January 2008 - On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials With Survival Endpoints (Page 92) Drug Information Journal - January 2008 - International Symposium on Adaptive Clinical Trial Designs (Page 93) Drug Information Journal - January 2008 - International Symposium on Adaptive Clinical Trial Designs (Page 94) Drug Information Journal - January 2008 - International Symposium on Adaptive Clinical Trial Designs (Page 95) Drug Information Journal - January 2008 - International Symposium on Adaptive Clinical Trial Designs (Page 96) Drug Information Journal - January 2008 - International Symposium on Adaptive Clinical Trial Designs (Page 97) Drug Information Journal - January 2008 - International Symposium on Adaptive Clinical Trial Designs (Page 98) Drug Information Journal - January 2008 - International Symposium on Adaptive Clinical Trial Designs (Page 99) Drug Information Journal - January 2008 - International Symposium on Adaptive Clinical Trial Designs (Page 100) Drug Information Journal - January 2008 - International Symposium on Adaptive Clinical Trial Designs (Page Cover3) Drug Information Journal - January 2008 - International Symposium on Adaptive Clinical Trial Designs (Page Cover4) http://www.nxtbookMEDIA.com
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