CRITERIA FOR THE CHOICE AND DEFINITION OF HEALTHY VOLUNTEERS AND/OR PATIENTS FOR PHASE I AND II STUDIES IN DRUG DEVELOPMENT

Información del proyecto

Identificador del acuerdo de subvención: B1

Proyecto cerrado

Fecha de inicio 24 Febrero 1986

Fecha de finalización 23 Febrero 1991

Financiado con arreglo a

• European cooperation in the field of scientific and technical research (COST), 1971-

Coste total

€ 25 000 000,00

Aportación de la UE

Sin datos

Coordinado por

CEC
Belgium

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Publicaciones

Other (33)

Recent dose-effect studies regarding antidepressants

Autores: PRESKORN S H (Deparment of Psychiatry and Behavioral Sciences, University of Kansas School of Medicine, Wichita and Psychiatric Research Institute (US))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 43-61, 1997, Página(s) 43-61, ISBN 92-828-3555-3

In search of the right comparator dose in antipsychotic drug evaluation studies: The case of Haloperidol

Autores: VAN KAMMEN D P (VA Pittsburgh Healthcare System and Department of Psychiatry, University of Pittsburgh (US))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 79-86, 1997, Página(s) 79-86, ISBN 92-828-3555-3

Is there a right dose of psychotropic drugs? A discussion of the methodological problems in clinical dose - effect studies

Autores: GRAM L F (Department of Clinical Pharmacology, Odense University (DK))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 1-11, 1997, Página(s) 1-11, ISBN 92-828-3555-3

Conference on the population approach: Measuring and managing variability in response, concentration and dose

Autores: CEC (CEC Bruxelles (BE))
Publicado en: Preliminary programme : EN (1996) 23pp. (euroabstract 34/1743), 1996, Página(s) 23, ISBN 92-827-7764-2

Influence of placebo in dose-response relationship studies

Autores: BERTSCHY G (Department of Psychiatry, University of Geneva (CH))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 87-98, 1997, Página(s) 87-98, ISBN 92-828-3555-3

D(2) occupancy and the mechanism of action of atypical antipsychotics: What's dose got to do with it?

Autores: PICKAR D ET AL (Experimental Therapeutics Branch, NIMH, Bethesda (US)), COPPOLA R ET AL (Clinical Brain Disorders Branch, NIMH, Bethesda (US))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 63-78, 1997, Página(s) 63-78, ISBN 92-828-3555-3

Neuro-imaging in antipsychotic drug dose-effect investigations

Autores: NYBERG S (Department of Clinical Neuroscience, Karolinska Hospital, Stockholm (SE))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 167-179, 1997, Página(s) 167-179, ISBN 92-828-3555-3

COST B1: Criteria for the choice and definition of healthy volunteers and/or patients in phase I and phase II studies in drug development

Autores: BOOBIS A R (EDITOR) (Imperial College School of Medicine, Department of Clinical Pharmacology, London (GB))
Publicado en: EUR 18394 EN (1998) 75pp., ECU 10.00, 1998, Página(s) 75, ISBN 92-827-4033-1

CYP1A2 activity and smoking influence the risk/benefit ratio of olanzapine in schizophrenic patients

Autores: CARRILLO J A, RAMOS S I, HERRÁIZ M A G, LOZANO L, BENÍTEZ J (Department of Pharmacology and Psychiatry, University of Extremadura, Badajoz (ES))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 293-295, 1997, Página(s) 293-295, ISBN 92-828-3555-3

Pronounced differences in the plasma concentrations of clomipramine between Japanese and Swedish patients

Autores: SHIMODA K (Department of Medical Laboratory Sciences and Technology, Karolinska Institute at Huddinge University Hospital (SE)), YASUDA S (Department of Medical Laboratory Sciences and Technology, Karolinska Institute at Huddinge University Hospital (SE)), MORITA S (Department of Medical Laboratory Sciences and Technology, Karolinska Institute at Huddinge University Hospital (SE)), JERLING M (Department of Psychiatry, Shiga University of Medical Science (JP)), BÖTTIGER Y (Department of Psychiatry, Shiga University of Medical Science (JP)), BERTILSSON L (Department of Psychiatry, Shiga University of Medical Science (JP))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 251-255, 1997, Página(s) 251-255, ISBN 92-828-3555-3

The use of radioligands in human psychopharmacology: Focus on anxiety and benzodiazepine-GABA(A) receptors

Autores: MALIZIA A L (MRC Cyclotron Unit, Hammersmith Hospital, London (GB)), NUTT D J (MRC Cyclotron Unit, Hammersmith Hospital, London (GB))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 181-196, 1997, Página(s) 181-196, ISBN 92-828-3555-3

Clinical dose prediction of psychotropic drugs based on phase I studies

Autores: ROSENZWEIG P (Clinical Development Department, Synthélabo Recherche, Bagneux (FR))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 21-29, 1997, Página(s) 21-29, ISBN 92-828-3555-3

The relevance of time-dependent sensitisation (TDS) to the mechanism of action of antidepressant medications

Autores: SOARES J C (Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine (US)), ANTELMAN S M (Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine (US)), GERSHON S (Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine (US))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 105-114, 1997, Página(s) 105-114, ISBN 92-828-3555-3

Role of the acetylation polymorphism on clonazepam metabolism: Kinetic differences of transiently expressed human enzymes NAT2*4, NAT2*5B and NAT2*6A

Autores: OLIVERA M ET AL (Department of Pharmacology, University of Extremadura, Badajoz (ES))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 267-272, 1997, Página(s) 267-272, ISBN 92-828-3555-3

Use of dose/concentration - response data in psychotropic drug development

Autores: SITSEN A (NV Organon, Oss (NL))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 115-125, 1997, Página(s) 115-125, ISBN 92-828-3555-3

Determination of appropriate dosage in clinical development: Guidance

Autores: GOLDSTEIN D J (Neuroscience Division, Lilly Research Laboratories, Indianapolis (US)), POTTER W Z (Neuroscience Division, Lilly Research Laboratories, Indianapolis (US))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 305-322, 1997, Página(s) 305-322, ISBN 92-828-3555-3

CYP2D6 polymorphism among patients treated with thioridazine

Autores: LLERENA A (Department of Pharmacology and Psychiatry, University of Extremadura, Badajoz (ES)), BERECZ R (Department of Pharmacology and Psychiatry, University of Extremadura, Badajoz (ES)), BENÍTEZ J (Department of Pharmacology and Psychiatry, University of Extremadura, Badajoz (ES)), DE LA RUBIA A (Psychiatric Hospital, Mérida (ES))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 285-289, 1997, Página(s) 285-289, ISBN 92-828-3555-3

Therapeutic drug monitoring of the SSRIs citalopram, paroxetine and sertraline in the treatment of depression in the elderly reduces drug costs

Autores: LUNDMARK J (Department of Psychiatry, Linköping University Hospital (SE)), NORDIN C (Department of Psychiatry, Linköping University Hospital (SE)), WÅLINDER J (Department of Psychiatry, Linköping University Hospital (SE)), BENGTSSON F (Clinical Pharmacology, Lund University Hospital (SE)), REIS M (Clinical Pharmacology, Lund University Hospital (SE))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 133-142, 1997, Página(s) 133-142, ISBN 92-828-3555-3

Role of CYP-enzymes in clinical psychopharmacology

Autores: AGÚNDEZ J A G (Department of Pharmacology and Psychiatry, University of Extremadura, Badajoz (ES)), BENÍTEZ J (Department of Pharmacology and Psychiatry, University of Extremadura, Badajoz (ES))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 257-266, 1997, Página(s) 257-266, ISBN 92-828-3555-3

Interaction between fluoxetine and clozapine: Pharmacokinetic and clinical implications

Autores: SPINA E ET AL (Institute of Pharmacology, University of Messina (IT)), FABRAZZO M ET AL (Department of Psychiatry, University of Naples (IT)), PERUCCA E (Department of Internal Medicine and Therapeutics, University of Pavia (IT))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 143-147, 1997, Página(s) 143-147, ISBN 92-828-3555-3

Antidepressants in the elderly: Assessment of serum anticholinergicity

Autores: POLLOCK B G (Department of Psychiatry, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic (US)), NEBES R (Department of Psychiatry, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic (US)), MULSANT B H (Department of Psychiatry, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic (US))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 161-166, 1997, Página(s) 161-166, ISBN 92-828-3555-3

Receptor polymorphisms and psychotropic drug response

Autores: BROCKMÖLLER J (Institute of Clinical Pharmacology, University Clinic Charite, Humboldt University of Berlin (DE)), KAISER R (Institute of Clinical Pharmacology, University Clinic Charite, Humboldt University of Berlin (DE)), ROOTS I (Institute of Clinical Pharmacology, University Clinic Charite, Humboldt University of Berlin (DE))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 203-232, 1997, Página(s) 203-232, ISBN 92-828-3555-3

CYP2D6 polymorphism in psychiatric patients during haloperidol monotherapy

Autores: BERECZ R (Department of Pharmacology and Psychiatry, University of Extremadura, Badajoz (ES)), LLERENA A (Department of Pharmacology and Psychiatry, University of Extremadura, Badajoz (ES)), BENÍTEZ J (Department of Pharmacology and Psychiatry, University of Extremadura, Badajoz (ES)), DE LA RUBIA A (Psychiatric Hospital, Mérida (ES))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 279-283, 1997, Página(s) 279-283, ISBN 92-828-3555-3

From theory to practice - is it easy? A study with hypnotic drugs

Autores: RAYÓN P, MONTERO D, MADURGA M, DE ABAJO F J (Area de Farmacovigilancia, Instituto de Salud Carlos III, Madrid (ES))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 197-201, 1997, Página(s) 197-201, ISBN 92-828-3555-3

Inhibition by some neurotransmitters of CYP3A activity in human liver microsomes

Autores: GERVASINI G ET AL (Department of Pharmacology, University of Extremadura, Badajoz (ES))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 273-278, 1997, Página(s) 273-278, ISBN 92-828-3555-3

European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs

Autores: BALANT L P (University of Geneva, Department of Psychiatry, Clinical Research Unit (CH)), BENÍTEZ J (University of Extremadura, Medical School, Department of Pharmacology and Psychiatry, Badajoz (ES)), DAHL S G (University of Tromsø, Department of Pharmacology (NO)), GRAM L F (Odense University, Department of Clinical Pharmacology (DK)), PINDER R M (NV Organon, Oss (NL)), POTTER W Z (EDITORS) (Lilly Research Laboratories, Indianapolis (US))
Publicado en: EUR 18168 EN (1997) 440pp., ECU 53, 1997, Página(s) 440, ISBN 92-828-3555-3

Inter-ethnic variability in psychotropic drug response

Autores: BALANT L P (Department of Psychiatry, University of Geneva (CH)), BALANT-GORGIA E A (Department of Psychiatry, University of Geneva (CH))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 233-249, 1997, Página(s) 233-249, ISBN 92-828-3555-3

Pharmacotherapy for the behavioural disorders of dementia: Application of pharmacogenetic probes

Autores: POLLOCK B G (Department of Psychiatry, University of Pittsburg School of Medicine (US))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 297-303, 1997, Página(s) 297-303, ISBN 92-828-3555-3

Role of active metabolites in the assessment of psychotropic drug response

Autores: BALANT L P (Department of Psychiatry, University of Geneva (CH)), GEX-FABRY M (Department of Psychiatry, University of Geneva (CH)), BALANT-GORGIA E A (Department of Psychiatry, University of Geneva (CH))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 127-132, 1997, Página(s) 127-132, ISBN 92-828-3555-3

Onset of response: A key issue in dose - concentration - effect studies

Autores: BALANT-GORGIA E A ET AL (Department of Psychiatry, Geneva University Hospitals (CH))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 99-104, 1997, Página(s) 99-104, ISBN 92-828-3555-3

Use of surrogate markers in clinical psychopharmacology

Autores: COWEN P J (University Department of Psychiatry, Warneford Hospital, Oxford (GB))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 151-160, 1997, Página(s) 151-160, ISBN 92-828-3555-3

On demonstrating the correct dose for new antidepressants: Dual action drugs

Autores: PINDER R M (NV Organon, Oss (NL)), ZIVKOV M (NV Organon, Oss (NL))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 31-42, 1997, Página(s) 31-42, ISBN 92-828-3555-3

Clinical dose prediction on the basis of preclinical data

Autores: BRILEY M (Institut de Recherche Pierre Fabre, Castres (FR))
Publicado en: Extract: European cooperation in the field of scientific and technical research: Clinical pharmacology in psychiatry: Finding the right dose of psychotropic drugs, Badajoz, Spain, 23-25 October 1997: Proceedings (1997) pp. 13-19, 1997, Página(s) 13-19, ISBN 92-828-3555-3