Optimizing the development of antipsychotic drugs:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Chichester [u.a.]
Wiley
1997
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | X, 204 S. graph. Darst. |
| ISBN: | 0471970115 |
Internformat
MARC
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Datensatz im Suchindex
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|---|---|
| adam_text | Contents
FOREWORD ix
ACKNOWLEDGEMENT xi
1 INTRODUCTION: THE WORLDWIDE MARKET FOR
ANTTPSYCHOTIC DRUGS 1
2 ATYPICAL ANTIPSYCHOTICS: MECHANISMS, AND
PRECLINICAL AND CLINICAL PROFILES 7
The dopamine hypothesis and the advent of atypical antipsychotics 7
The mechanism of action of atypical antipsychotics 13
Tonic versus phasic dopamine release 16
Partial dopaminergic agonists 17
Antagonism at other dopamine receptor subtypes 18
Serotonin dopamine antagonists 19
Glutamatergic NMDA receptors 22
Preclinical profile of atypical antipsychotic drugs 26
Assays of dopaminergic function 26
Assays of glutamatergic function 28
Assays of serotonergic function 28
Safety and efficacy of atypical antipsychotics in clinical trials 29
Side effects 29
Extrapyramidal symptoms and tardive dyskinesia 29
Cardiovascular effects 30
Anticholinergic effects 31
Sedation 31
Prolactin 32
Liver enzymes 32
Weight gain 33
Hematological effects 33
Efficacy 33
Overall comparison to typical compounds 33
Efficacy in treatment refractory patients 35
Efficacy against negative symptoms in acute and chronic
schizophrenic patients 36
Genetics of schizophrenia and potential therapeutic interventions 38
3 REVIEW OF THE CLINICAL DEVELOPMENT OF
ATYPICAL ANTIPSYCHOTIC COMPOUNDS 53
The development of clozapine 53
vi CONTENTS
The development of risperidone 58
FDA Psychopharmacologic Drugs Advisory Committee 64
Special NDA meeting on preclinical toxicity 67
The development of sertindole 70
The development of olanzapine 80
Atypical antipsychotics currently in the pipeline 82
Selected compounds in Phase III 82
Seroquel 82
Ziprasidone 84
Other selected compounds 85
Zotepine 85
Iloperidone 86
MDL 100,907 88
Ocaperidone 89
ORG 5222 89
Pramipexole 89
Melperone 90
Sulpiride 90
Amisulpride 91
4 PHASE I CLINICAL DEVELOPMENT AND FINDING THE
DOSE: THE ROLE OF THE BRIDGING STUDY 101
Introduction 101
Examples of bridging studies in other CNS indications 104
Bridging studies in schizophrenia 105
Examples of bridging studies with atypical antipsychotics 107
MDL 100,907 107
Iloperidone 110
A novel D4/5 HT2 compound 116
A novel dopamine autoreceptor agonist 120
Sertindole 121
Bridging study summary 123
5 GENERAL METHODOLOGICAL ISSUES IN
ANTIPSYCHOTIC DRUG DEVELOPMENT 127
Study methodology 127
Patient selection and diagnosis 127
Washout periods 135
Placebo effects 137
Sample size and statistical power 139
Multicenter versus single site studies 140
Rating scales 141
Safety 142
EPS and tardive dyskinesia 143
CONTENTS vii
Efficacy 144
What defines clinical efficacy? 146
FDA meeting on antipsychotic drug development 146
6 SPECIAL METHODOLOGICAL ISSUES IN
ANTIPSYCHOTIC DRUG DEVELOPMENT 155
Clinical pharmacology studies 155
Pharmacokinetics 155
A bioequivalence study of clozapine 156
Drug interactions 160
Gender differences 163
Ethnic differences 165
Pharmacodynamics: Biological markers 169
Homovanillic acid 170
Prolactin 171
Growth hormone 172
Pharmacodynamics: Novel imaging techniques 173
Early subjective response and treatment outcome 175
Neuropsychological testing in schizophrenia 176
Cognitive effects of antipsychotics 176
Use of the CNTB in trials of antipsychotics 178
7 CONCLUDING REMARKS ON DRUG DEVELOPMENT 191
INDEX 197
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| indexdate | 2024-07-09T18:13:16Z |
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| isbn | 0471970115 |
| language | English |
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| spelling | Optimizing the development of antipsychotic drugs John J. Sramek ... Chichester [u.a.] Wiley 1997 X, 204 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Antipsychotic Agents pharmacology Antipsychotic drugs Design Antipsychotic drugs Testing Clinical Trials as Topic Psychose (DE-588)4047734-4 gnd rswk-swf Psychopharmakon (DE-588)4047729-0 gnd rswk-swf Arzneimitteldesign (DE-588)4278218-1 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Psychose (DE-588)4047734-4 s Psychopharmakon (DE-588)4047729-0 s Arzneimitteldesign (DE-588)4278218-1 s DE-604 Sramek, John J. Sonstige oth HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007846331&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Optimizing the development of antipsychotic drugs Antipsychotic Agents pharmacology Antipsychotic drugs Design Antipsychotic drugs Testing Clinical Trials as Topic Psychose (DE-588)4047734-4 gnd Psychopharmakon (DE-588)4047729-0 gnd Arzneimitteldesign (DE-588)4278218-1 gnd |
| subject_GND | (DE-588)4047734-4 (DE-588)4047729-0 (DE-588)4278218-1 (DE-588)4143413-4 |
| title | Optimizing the development of antipsychotic drugs |
| title_auth | Optimizing the development of antipsychotic drugs |
| title_exact_search | Optimizing the development of antipsychotic drugs |
| title_full | Optimizing the development of antipsychotic drugs John J. Sramek ... |
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| title_full_unstemmed | Optimizing the development of antipsychotic drugs John J. Sramek ... |
| title_short | Optimizing the development of antipsychotic drugs |
| title_sort | optimizing the development of antipsychotic drugs |
| topic | Antipsychotic Agents pharmacology Antipsychotic drugs Design Antipsychotic drugs Testing Clinical Trials as Topic Psychose (DE-588)4047734-4 gnd Psychopharmakon (DE-588)4047729-0 gnd Arzneimitteldesign (DE-588)4278218-1 gnd |
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