training programme in pharmaceutical medicine clinical pharmacology

Transcription

1 training programme in pharmaceutical medicine clinical pharmacology nov 2010

2 clinical pharmacology NOVEMBER 2010 Local: University of Aveiro, Campus Universitário de Santiago Curricular Unit Leader: Luis Almeida, MD, PhD, FFPM Lecturers: Vera Afreixo, Luis Almeida, Adelaide Alvarez, Ana Filipa Bernardo, Pedro Sá Couto, Amilcar Falcão, Miguel Forte, Adel Nada, Maria João Salgado. Organisation: Mestrado em Biomedicina Farmacêutica (Masters in Pharmaceutical Biomedicine) Curso de Especialização em Medicina Farmacêutica de Longa Duração (Post-Graduate Course in Pharmaceutical Medicine) Director: Luis Almeida, MD, PhD, FFPM Deputy Director: Bruno Gago, PharmD, PhD ua.pt) Address: Secção Autónoma de Ciências da Saúde (SACS) Universidade de Aveiro Campus Universitário de Santiago Edifício III Aveiro Portugal Tel Fax

3 Day november Time Programme Lecturer 1. Overview of a Clinical Development Plan 09h00-11h00 11h00-12h00 12h00-13h Basis of a clinical development plan. Intended therapeutic indications, biomarkers, efficacy endpoints and criteria for go, no-go decisions. 2. Good Clinical Practice (GCP) 2.1. Principles of Good Clinical Practice and procedures applied in all stages of the clinical trial process to ensure subject protection, scientific validity and safety Quality management system; standard operating procedures (SOPs); quality assurance and quality control; monitoring;independent audits; inspections. Miguel Forte (TxCell Belgium) Maria João Salgado (Eurotrials) Ana Filipa Bernardo (Eurotrials) 13h00-14h00 14h00-16h00 16h00-18h00 (Lunch) 3. Clinical Trial Documentation 3.1. Clinical Trial Application (CTA) and Investigational Medicinal Product Dossier (IMPD); the US IND Investigator Brochure (IB): content, review and maintenance Trial Master File (TMF) Clinical Trial Protocol (CTP) preparation and review Clinical Trial Report (CTR). Adelaide Alvarez (Quintiles) Luis Almeida (UA)

4 Day NOVEMBER Time Programme Lecturer 4. Human Pharmacology Studies 09h00-13h The role of clinical pharmacology studies in early clinical development and overall development programmes Exploratory phase 0 trials First-in-human studies: Preclinical studies, dose selection, design, safety monitoring, stopping rules, ethics, sponsor governance Innovative approaches and trends: Pharmacodynamic assessment in clinical pharmacology studies, biomarkers and surrogate endpoints for safety and efficacy, industry success stories Early and late clinical pharmacology studies: Food effect studies, drug-drug interaction studies, definitive ECG studies, bioavailability/bioequivalence studies, special populations. Adel Nada (Abbot USA) 13h00-14h00 14h00-18h00 (Lunch) 4.6. Specificities of biotechnology products and vaccines Contract Research Organizations (CRO): Fully integrated pharmaceutical company versus fully integrated pharmaceutical network, preferred provider agreements, CRO management Adverse events: Expected variability in healthy volunteers, tolerability versus safety, laboratory adverse events Healthy volunteer personality related issues Healthy volunteers pay and national databases. Adel Nada (Abbot USA)

5 Day NOVEMBER Time Programme Lecturer 5. Introduction to Human Pharmacokinetics and Pharmacodynamics 09h00-13h00 13h00-14h00 14h00-16h00 16h00-18h Pharmacokinetics, ADME and pharmacokinetic/ pharmacodynamic models Concepts of half-life, volume of distribution, clearance Pharmacokinetic parameters as determined by a standard approach Extrinsic and intrinsic factors (drug-drug interactions, food effect, gender and age-effect, etc.) Population pharmacokinetics Pharmacogenomics and pharmacogenetics Applicability of pharmacokinetics to dosage regimen and study design. (Lunch) 6. Modelling and simulation 6.1. Modelling techniques for human pharmacokinetics and pharmacodynamics (compartmental vs noncompartmental models) Simulation and parameters estimation tools (NONMEM, WinNonLin, MatLab) Presentation and critical analysis of two selected articles. 7. First administration to patients 7.1. Principles of proof-of-concept and dose-finding studies Impact of results on planned therapeutic indications, on predicted dosage schedule, on additionally required animal toxicology and on drug delivery concepts / forms. Amílcar Falcão (FFUC & 4Health Consulting) Vera Afreixo & Pedro Sá Couto (UA) Luis Almeida (UA )

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