Department of Clinical Pharmacology - Faculty of Medicine Gadjah Mada University

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September 08, 2010

STATISTICS

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1532416

Since :
January 15, 2003

CONTACT

Department of Clinical Pharmacology
IKM Building 2nd Floor,
Faculty of Medicine,
Gadjah Mada University,
Yogyakarta 55281,
Indonesia.
Phone :+62 274 563596
+62 274 6492548
Fax :+62 274 563596
+62 274 543711
e-mail:
farklin@yogya.wasantara.
net.id
or mail@farklin.com

PHARMACOKINETICS AND BIOAVAILABILITY STUDIES

Bioavailability study is a step in establishing the quality of pharmaceutical product, prior to or after marketing approval. This study aims to ascertain if a pharmaceutical product is appropriately absorbed after administration. Besides its importance in establishing the quality of conventional dosage forms of pharmaceutical products, such study is also crucial in providing the evidence of good absorption of modified formulation such as controlled-release preparations and fixed-dose combinations.

Department of Clinical Pharmacology provides services in bioavailability studies of new formulations as well as comparative bioavailability studies. An international standard methodology for phase I clinical trial, i.e., Good Clinical Research Practices Guidelines are applied to all bioavailability studies. Such study shall be completed within 3-7 months, depending on the study design and the pharmacokinetic properties of the study drug.

Since 1987, Department of Clinical Pharmacology has accomplished more than 160 studies.

. Saleh-Danu S, Suryawati S (2004) The Quality of Generic Products in Indonesia. Presented in 8th World Congress on Clinical Pharmacology and Therapeutics (CPT2004 BRISBANE).

. Rustamaji A, & Suryawati S (2004) Ibuprofen Suppository Provides Equal Bioavailability to the Oral Preparation. Presented in 8th World Congress on Clinical Pharmacology and Therapeutics (CPT2004 BRISBANE).

. List of Active Ingredients Have Been Studied

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