Phase I and Bioequivalence Studies

Transcription

1 Phase I and Bioequivalence Studies

2 Statistics (2007) 68 bioequivalence and 26 phase I studies (17 % of all studies) 72 % of clinical studies are sponsored by foreign companies (leading countries of sponsor s origin: USA, Germany, UK, Switzerland, France) 59 centers participated in phase I studies

3 General Russian resources overview physicians (4,19 per inhabitants), 1,6 mn nurses (11,2 per inhabitants) hospitals (1,6 mn hospital beds, 10,84 per inhabitants), acute care (short stay) hospitals, out-patient facilities, primary care units 55 medical universities & postgraduate education institutes, 145 medical scientific research institutes 877 medical institutions entitled by Ministry of Health to conduct clinical trials

4 Recommended BE/phase I units (1) Scientific-Research Influenza Institute of Russian Academy of Medical Sciences (St-Petersburg) Location: Clinics of Influenza Institute Head: Prof. O. Kisilyov

5 Recommended BE/phase I units (2) Peoples Friendship University (Moscow) Location: Municipal Clinical Hospital No. 64 and Medical-Sanitary Unit of Moscow Building Department ( Glavmosstroj ) Heads: Prof. V. Moiseev and Prof. J. Kobalava

6 Recommended BE/phase I units (3) Moscow Medical Academy (Moscow) Location: Internal Diseases, Gastroenterology and Hepatology Clinics named after V. Vasilenko Head: Prof. S. Fitilyov

7 Recommended BE/phase I units (4) Innovative Pharmacological Research Company (Tomsk) Head: Prof. V. Khazanov

8 Possibilities Phase I / IIa studies (single dose, multi dose) with special patient population (incl. treatment naive). - Efficacy/dose finding studies - Studies in renally / hepatically impaired patients, patients with various concomitant diseases (diabetes, asthma, chronic heart failure, etc.) Phase I (single dose, multi dose) with healthy volunteers - PK studies with new formulations of already approved compounds - BE and BA studies - Food effect studies - Vaccine studies

9 Advantages of BE/phase I studies in Russia Access to large pool of healthy volunteers and special patients Subjects of caucasian ethnicity High recruitment rate Experienced study personnel, well-trained in GCP regulations and EDC systems Possibility to perform necessary tests in local, central Russian and/or central international lab Relatively low prices

10 AMT services Established relationships with study sites, Ethics Committees and Authorities Quick and reliable project and site management, including: Obtaining permissions for study conduction from RF Ministry of Health, Central and local ECs votes Study medication import, customs clearance and distribution to study sites (own storage facilities) Export of biological samples to central lab Contracting with study sites/investigators, administration of fees

11 Experience (1) Pharmacokinetics of IMP and metabolites in subjects with severe renal impairment and matched healthy control subjects (multiple sclerosis) Multiple dose pharmacokinetics of IMP and its metabolites in subjects with severe renal impairment compared to matched healthy subjects (hypertension) Investigation of bronchodilatory effect of IMP in patients with Chronic Obstructive Pulmonary Disease Safety/tolerability, pharmacokinetics and pharmacodynamics of IMP in patients with stable heart failure

12 Experience (2) Safety, tolerability, pharmacokinetics and pharmacodynamics of IMP in patients with type 2 diabetes mellitus Dose escalation study of two doses of IMP in healthy adults (avian influenza vaccine) Study of single dose of trivalent influenza vaccine in healthy adults Pharmacokinetic equivalence study of IMP compared to marketed product in patients with locally advanced or metastatic non-small cell lung cancer

13 AMT contacts pr. Vernadskogo, 38A, office 29 Moscow Russia Tel Web: