2.1 ctd の目次（第 2 部）...[lieberman ja, safferman az (1992)] clinical profile of...

2.1 CTD の目次（第 2 部から第 5 部）

Novartis Confidential CTD 2.1 CTD の目次 LEX123/クロザリル錠

目次目次 .................................................................................................................................2

1 第 2 部 .................................................................................................................................3 2 第 3 部 .................................................................................................................................4 3 第 4 部 ...............................................................................................................................10 4 第 5 部 ...............................................................................................................................21


1 第 2 部

表題巻番号添付資料番号

2.1 CTD の目次（第 2 部から第 5 部） 3 2.1

2.2 緒言 3 2.2

2.3 品質に関する概括資料 3 2.3

2.3.S 原薬 3 2.3.S

2.3.P 製剤 3 2.3.P

2.3.A その他 3 2.3.A

2.3.R 各極の要求資料 3 2.3.R

該当資料なし－－

2.4 非臨床試験の概括評価 3 2.4

2.5 臨床に関する概括評価 3 2.5

2.6 非臨床試験の概要文及び概要表 3 2.6

2.6.1 緒言 3 2.6.1

2.6.2 薬理試験の概要文 3 2.6.2

2.6.3 薬理試験概要表 3 2.6.3

2.6.4 薬物動態試験の概要文 3 2.6.4

2.6.5 薬物動態試験概要表 3 2.6.5

2.6.6 毒性試験の概要文 3 2.6.6

2.6.7 毒性試験概要表 3 2.6.7

2.7 臨床概要 3 2.7

2.7.1 生物薬剤学及び関連する分析法の概要 3 2.7.1

2.7.2 臨床薬理の概要 3 2.7.2

2.7.3 臨床的有効性の概要 3 2.7.3

2.7.4 臨床的安全性の概要 3 2.7.4

2.7.5 参考文献 3 2.7.5

2.7.6 個々の試験のまとめ 3 2.7.6


3 第 4 部


4.1 第 4 部目次 5 4.1

4.2 試験報告書 5 4.2

4.2.1 薬理試験 5 4.2.1

4.2.1.1 効力を裏付ける試験 5 4.2.1.1

[Bymaster FP, Calligaro DO, Falcone JF, et al (1996)] Lilly Corporate Center, USA Radioreceptor binding profile of the atypical antipsychotic olanzapine. Neuropsychopharmacol; 14: 87-96

5 4.2.1.1-1 参考資料

[Bruhwyler J, Liegeois JF, Bergman J, et al (1997)] Therabel Research SA, Belgium JL13, a pyridobenzoxazepine compound with potential atypical antipsychotic activity: a review of its behavioural properties. Pharmacol Res; 36: 255-64

5 4.2.1.1-2 参考資料

[Rigdon GC, Norman MH, Cooper BR, et al (1996)] Glaxo Welcome Inc, USA1192U90 in animal tests that predict antipsychotic efficacy, anxiolysis, and extrapyramidal side effects. Neuropsychopharmacol; 15: 231-42

5 4.2.1.1-3 参考資料

[Moore NA, Tye NC, Axton MS, et al (1992)] Eli Lilly Co, UK The behavioral pharmacology of olanzapine, a novel “atypical” antipsychotic agent. J Pharmacol Exp Therp; 262: 545-51

5 4.2.1.1-4 参考資料

[Corbett R, Camacho F, Woods AT, et al (1995)] Hoechst-Roussel Pharmaceuticals Inc, USA Antipsychotic agents antagonize non-competitive N-methyl-D-aspartate antagonist-induced behaviors. Psychopharmacol; 120: 67-74

5 4.2.1.1-5 参考資料

[Corbin AE, Meltzer LT, Ninteman FW, et al (2000)] Warner-Lambert Co, USA PD 158771, a potential antipsychotic agent with D2/D3 partial agonist and 5-HT1A agonist actions.Ⅱ. Preclinical behavioral effects. Neuropharmacol; 39: 1211-21

5 4.2.1.1-6 参考資料

[Arnt J (1995)] H. Lundbeck A/S, Denmark Differential effects of classical and newer antipsychotics on the hypermotility induced by two dose levels of D-amphetamine. Eur J Pharmacol; 283: 55-62

5 4.2.1.1-7 参考資料

[Okuyama S, Kawashima N, Chaki S, et al (1999)] Taisho Pharmaceutical Co, Japan A selective dopamine D4 receptor antagonist, NRA0160: a preclinical neuropharmacological profile. Life Sci; 65: 2109-25

5 4.2.1.1-8 参考資料

[Sanchez C, Arnt J, Dragsted N, et al (1991)] H. Lundbeck A/S, Denmark Neurochemical and in vivo pharmacological profile of sertindole, a limbic-selective neuroleptic compound. Drug Dev Res; 22: 239-50

5 4.2.1.1-9 参考資料

[Arnt J, Skarsfeldt T (1998)] H. Lundbeck A/S, Denmark Do novel antipsychotics have similar pharmacological characteristics? A review of the evidence. Neuropsychopharmacol; 18: 63-101

5 4.2.1.1-10 参考資料

[Shannon HE, Rasmussen K, Bymaster FP, et al (2000)] Eli Lilly Co, USA Xanomeline, an M1/M4 preferring muscarinic cholinergic receptor agonist, produces antipsychotic-like activity in rats and mice. Schizophr Res; 42: 249-59

5 4.2.1.1-11 参考資料



[Tollefson GD, Birkett MA, Kiesler GM, et al (2001)] The Lilly Resistant Schizophrenia Study Group. Double-blind comparison of olanzapine versus clozapine in schizophrenic patients clinically eligible for treatment with clozapine. Biol Psychiatry; 49: 52-63.

24 5.4-7 参考資料

[Conley RR, Tamminga CA, Bartko JJ, et al (1998)] Olanzapine compared with chlorpromazine in treatment-resistant schizophrenia. Am J Psychiatry; 155: 914-20.

24 5.4-8 参考資料

[Wirshing DA, Marshall BD Jr, Green MF, et al (1999)] Risperidone in treatment-refractory schizophrenia. Am J Psychiatry; 156: 1374-9.

24 5.4-9 参考資料

[Zarate CA Jr. Schizophrenia. In: Fawcett J, Stein DJ, Jobson KO, editors (1999)]. Textbook of treatment algorithms in psychoparmacology. West Sussex: John Wiley & Sons; p. 67-85.

24 5.4-10 参考資料

[Osser DN, Zarate CA Jr.(1999)] Consultant for the pharmacotherapy of schizophrenia. Psychiatr Ann; 29: 252-67.

24 5.4-11 参考資料

[Miller AL, Chiles JA, Chiles JK,et al (1999)] The Texas Medication Algorithm Project (TMAP) schizophrenia algorithms. J Clin Psychiatry; 60: 649-57.

24 5.4-12 参考資料

[Treatment of schizophrenia (1999)]. The expert consensus guideline series [editorial]. J Clin Psychiatry; 60 Suppl 11: 3-80.

24 5.4-13 参考資料

[National Institute for Clinical Excellence (2002)]. Guidance on the use of newer (atypical) antipsychotic drugs for the treatment of schizophrenia. NICE Technology Appraisal Guidance No. 43. 2002 Jun.

24 5.4-14 参考資料

[伊藤千裕, 佐藤光源 (2001)] 慢性期精神分裂病の合理的薬物選択ア

ルゴリズム. 脳の科学; 23: 789-92. 24 5.4-15

参考資料

[谷向弘，乾正，高橋尚武，他 (1973)] 大阪大学二重盲検法による Clozapine の精神分裂病に対する薬効検定. 精神医学; 15: 269-84

24 5.4-16 参考資料

[八木剛平，三浦貞則，田代厳，他 (1974) ] 皆川病院他，計 9 施設

二重盲検法による clozapine と haloperidol の精神分裂病に対する薬効の

比較. 臨床評価; 2: 169-206

24 5.4-17 参考資料

[佐藤時治郎，本間俊行，佐久間有寿，他 (1972)] 弘前大学他，計

2 施設新向精神薬 W 801 (Clozapine )の臨床治験－精神分裂病に対する効果を

中心として－新薬と臨床; 21: 743-59

24 5.4-18 参考資料

[渡辺昌祐，藤原二郎，松田清，他 (1972)] 岡山大学 Clozapine の臨床薬理学的検討. 新薬と臨床; 21: 763-75

24 5.4-19 参考資料

[本田修，山本明，柳生雋，他 (1972)] 札幌医科大学他，計 2 施設 Phenothiazine 誘導体との比較による W-801 の陳旧性精神分裂病に対す

る臨床治験. 新薬と臨床; 21: 777-84

24 5.4-20 参考資料

[桜井図南男，山内万寿美，中沢洋一 (1972)] 九州大学他，計 3 施

設新しい向精神薬 W 801（Clozapine）の使用経験. 新薬と臨床; 21: 1339-47

24 5.4-21 参考資料

[新里邦夫，上津原甲一，佐保威彦 (1972)] 鹿児島大学他，計 2 施

設 Clozapine の使用経験－主として慢性分裂病の長期観察－新薬と臨床; 21: 1349-56

24 5.4-22 参考資料



[Sassim N, Grohmann R (1988)] Adverse drug reactions with clozapine and simultaneous application of benzodiazepines. Pharmacopsychiat; 21: 306-7.

24 5.4-40 参考資料

[Friedman LJ, Tabb SE, Worthington JJ (1991)] Clozapine - a novel antipsychotic agent [letter]. N Engl J Med; 325: 518.

24 5.4-41 参考資料

[Lieberman JA, Safferman AZ (1992)] Clinical profile of clozapine: adverse reactions and agranulocytosis. Psychiatr Q; 63: 51-70.

24 5.4-42 参考資料

[Devinsky O, Honigfeld G, Patin J (1991)] Clozapine-related seizures. Neurology; 41: 369-71.

24 5.4-43 参考資料

[Conley RR, Tamminga CA, Kelly DL (1999)] Treatment-resistant schizophrenic patients respond to clozapine after olanzapine non-response. Biol Psychiatry; 46: 73-7.

24 5.4-44 参考資料

[McEvoy JP, Lieberman JA, Scott Stroup T, et al (2006)] John Umstead Hospital Effectiveness of clozapine versus olanzapine, quetiapine, and risperidone in patients with chronic schizophrenia who did not respond to prior atypical antipsychotic treatment. Am J Psychiatry; 163: 600-10

24 5.4-45 参考資料

[Kilian JG, Kerr K, Lawrence C et al (1999)] Myocarditis and cardiomyopathy associated with clozapine. Lancet; 354: 1841-5.

24 5.4-46 参考資料

[Murray CJL, Lopez AD (1996)]. Global health statistics: a compendium of incidence, prevalence, and mortality estimates for over 200 conditions. In Global Burden of Disease and Injury Series, Volume II; Boston: Harvard University Press: 1-33.

24 5.4-47 参考資料

[Cho HS, Kim CH, Lee HS (1999)] Agranulocytosis and neutropenia in clozapine-treated patients with schizophrenia in Korea [abstract]. Schizophr Res; 36: 274-5.

24 5.4-48 参考資料

[Copolov DL, Bell WR, Benson WJ et al (1998)] Clozapine treatment in Australia: a review of haematological monitoring. Med J Aust; 168: 495-7.

24 5.4-49 参考資料

[Galderisi S, Bucci P (1998)] The Italian Clozapine System (ICLOS) for treatment monitoring: more than 2 years of experience [letter]. Eur Psychiatry; 13: 52.

24 5.4-50 参考資料

[Krupp P, Barnes P (1992)]. Clozapine-associated agranulocytosis: risk and aetiology. Br J Psychiatry; 160 Suppl 17: 38-40.

24 5.4-51 参考資料

[Munro J, O’sullivan D, Andrews C, et al (1999)] Active monitoring of 12760 clozapine recipients in the UK and Ireland. Br J Psychiatry; 175: 576-80.

24 5.4-52 参考資料

[Kang BJ, Cho MJ, Oh JT, et al (2006)] Long-term patient monitoring for clozapine-induced agranulocytosis and neutropenia in Korea: when is it safe to discontinue CPMS? Hum Psychopharmacol Clin Exp; 21: 387-91.

24 5.4-53 参考資料

[George TP, Innamorato L, Sernyak MJ, et al (1998)] Leukopenia associated with addition of paroxetine to clozapine [letter]. J Clin Psychiatry; 59: 31.

24 5.4-54 参考資料

[Haller E, Binder RL (1990)] Clozapine and seizures. Am J Psychiatry; 147: 1069-71.

24 5.4-55 参考資料

[Simpson GM, Lee JH, Shrivastava RK (1978)] Clozapine in tardive dyskinesia. Psychopharmacology; 56: 75-80.

24 5.4-56 参考資料

[Mauthe VJ, Rether H, Winter E (1980)] Forced switching from one neuroleptic drug to another / problems of clozapine treatment. Arzneim- Forsch; 30: 1209.

24 5.4-57 参考資料



[Small JG, Milstein V, Marhenke JD, et al (1987)] Treatment outcome with clozapine in tardive dyskinesia, neuroleptic sensitivity, and treatment-resistant psychosis. J Clin Psychiatry; 48: 263-7.

24 5.4-58 参考資料

[de Leon J, Stanilla JK, White AO, et al (1994)] Anticholinergics to treat clozapine withdrawal [letter]. J Clin Psychiatry; 55: 119-20.

24 5.4-59 参考資料

[Shiovitz TM, Welke TL, Tigel PD, et al (1996)] Cholinergic rebound and rapid onset psychosis following abrupt clozapine withdrawal. Schizophr bull; 22: 591-5.

24 5.4-60 参考資料

[Ekblom B, Eriksson K, Lindström LH (1984)]. Supersensitivity psychosis in schizophrenic patients after sudden clozapine withdrawal. Psychopharmacology; 83: 293-4.

24 5.4-61 参考資料

[ぜんかれん]. 1995 年 11 月号及び 12 月号，1996 年 1 月号 24 5.4-62 参考資料

[村崎光邦 (2005)].わが国における clozapine の開発の経緯.臨床精神薬

理; 8: 104-10. 24 5.4-63

参考資料

2.1 ctd の目次（第 2 部）...[lieberman ja, safferman az (1992)] clinical profile of...

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