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Antiepileptic Drug Trials

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Antiepileptic Drug Development features contributions from academic investigators and representatives of pharmaceutical companies, the National Institutes of Health, and the Food and Drug Administration. Together, these experts provide unique insights into the theoretical and practical issues involved in preclinical drug development, Phase I and Phase II clinical trials, clinical trials for special patient populations, and postmarketing studies. Among the key issues addressed are new drug discovery, current trial...
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Overview

Antiepileptic Drug Development features contributions from academic investigators and representatives of pharmaceutical companies, the National Institutes of Health, and the Food and Drug Administration. Together, these experts provide unique insights into the theoretical and practical issues involved in preclinical drug development, Phase I and Phase II clinical trials, clinical trials for special patient populations, and postmarketing studies. Among the key issues addressed are new drug discovery, current trial methodology, innovative trial designs, antiepileptic drug evaluation procedures and criteria, and global drug development. The book highlights methods for the extension of clinical trials to pediatric patients, women of childbearing age, the elderly, and patients with new onset epilepsy. In addition, it provides a timely update on newly released drugs in the United States.

Topics incl. mechanism of action of new antiepileptic drugs, new drugs for persons with epilepsy, monotherapy trials, etc

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Product Details

  • ISBN-13: 9780397518487
  • Publisher: Lippincott Williams & Wilkins
  • Publication date: 12/28/1997
  • Series: Advances in Neurology Series
  • Edition number: 1
  • Pages: 276

Table of Contents

Contributing Authors
Preface
Acknowledgments
I Preclinical Antiepileptic Drug Development
1 Mechanism of Action of New Antiepileptic Drugs 1
2 Mechanism-Specific Pathways for New Antiepileptic Drug Discovery 11
3 The National Institutes of Health Anticonvulsant Drug Development Program: Screening for Efficacy 29
4 Pharmaceutical Industry Screening for New Antiepileptic Drugs 41
5 Metabolic Enzymes and Antiepileptic Drug Interactions 49
II Clinical Drug Development
6 New Drugs for Persons with Epilepsy 57
7 AED Doses: From Animals to Humans 89
8 Assessing Pharmacokinetic and Pharmacodynamic Drug Interactions in Clinical Trials of Antiepileptic Drugs 95
9 Novel Methods for Studying New Antiepileptic Drug Pharmacology 105
10 The Art of Antiepileptic Trial Design 113
11 Reanalysis of Existing Trial Data: What Can Be Learned 125
12 Monotherapy Trials 133
13 The Impact of Foreign Data on a New Drug Application 143
III Special Populations
14 Issues for Women in Antiepileptic Drug Development 149
15 Antiepileptic Drug Trials in Children and Adolescents: Is There a Need? 161
16 Pediatric Trials: Practical Issues. Special Populations and Trial Design 167
17 Clinical Trials for Status Epilepticus 173
18 Clinical Trials for Seizure Prevention 179
IV Special Issues
19 Alternate Endpoints for Seizure Measurement 189
20 Alternate Endpoints: Studies in Quality of Life and Health Economics of Epilepsy 195
21 Alternate Endpoint: EEG Assessment of Antiepileptic Drug Efficacy and Toxicity 209
22 Routine Measurement of New Antiepileptic Drug Concentrations: A Critique and a Prediction 223
23 Cognitive and Behavioral Assessments in AED Trials 231
24 Economic Factors in the Development of New Antiepileptic Drugs 239
25 Recent Issues and Considerations in the Regulation of Antiepileptic Drugs 245
26 Ethical and Institutional Review Board Issues 253
27 Postmarketing Studies 263
Subject Index 267
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