Faculty of Pharmacy
Faculty of Pharmacy
Faculty of Pharmacy
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(ECZ728) FORMULATION DESIGN AND QUALITY CONTROL PROCESS OF<br />
HERBAL MEDICINAL DRUGS (T)<br />
HOUR/WEEK :1, ECTS:1<br />
Preparation methods <strong>of</strong> herbal medicinal drugs (as liquid dosage forms, capsules, tablets,<br />
transdermal formulations, particular dosage forms, compress and bolus), Biopharmaceutical<br />
characterization <strong>of</strong> herbal medicinal drugs, Standardization <strong>of</strong> herbal medicinal drugs, Bioavailability<br />
<strong>of</strong> herbal medicinal drugs, Stability <strong>of</strong> herbal medicinal drugs, Quality assurance <strong>of</strong> herbal medicinal<br />
drugs, Dosage forms <strong>of</strong> herbal medicinal drugs and GMP.<br />
(ECZ729) BASIC PHARMACEUTICAL PROCESSES (T)<br />
HOUR/WEEK :1, ECTS:1<br />
Selection <strong>of</strong> parameters to investigate, depending on the dosage form to be developed. Selection <strong>of</strong><br />
parameters to investigate, depending on active agent. Selection <strong>of</strong> parameters to investigate,<br />
depending on polymer and excipients. Solubility and dissolution rate mechanism and determination<br />
in media and polymer. Determination <strong>of</strong> diffusion coefficient and its importance in bioavailability.<br />
Determination <strong>of</strong> partition coefficient and its importance in formulation. Particle size analysis and its<br />
importance in formulation.<br />
(ECZ730) DRUG SAFETY AND RISK ASSESSMENT IN DRUG USE (T)<br />
HOUR/WEEK: 2, ECTS:2<br />
Introduction <strong>of</strong> drug safety; Role <strong>of</strong> risk assessment in risk management; Constituting risk<br />
information during clinical trials; Special issues that must be taken into consideration during risk<br />
assessment; Pre-clinic and clinic studies before approval stage <strong>of</strong> drug; Adverse drug reactions (ADRs)<br />
and pharmacovigilance; Importance <strong>of</strong> pharmacovigilance and ADR monitoring centers; Importance<br />
<strong>of</strong> adverse drug reactions (ADR) in terms <strong>of</strong> patient harm and deaths; Post-marketing monitoring and<br />
reports <strong>of</strong> ADR; Withdrawal <strong>of</strong> drugs from market due to toxic effects; Classification <strong>of</strong> adverse drug<br />
effects and type A adverse reactions; Type B adverse reactions: Idiosyncratic reactions and<br />
underlying factors; ADRs not dependent to dose; Hypersensitivity; Allergy; Allergic drug reactions,<br />
anaphylaxis and serious dermal reactions; Photoallergy; Hepatotoxicity and blood discrasies;<br />
Induction and inhibition; Safety <strong>of</strong> vegetal drugs; Adverse effects due to genetic polymorphism in<br />
drug metabolizing enzymes; Polymorphism <strong>of</strong> Cytochrome P450 (CYP) and Phase II enzymes; Drug<br />
safety in future<br />
(ECZ731) GENETIC FACTORS IN EFFICIENT DRUG USE (T)<br />
HOUR/WEEK:1, ECTS:1<br />
Role <strong>of</strong> interindividual genetic differences in drug use; Mechanisms <strong>of</strong> interindividual genetic<br />
differences in drug use; The toxicity originated from interindividual genetic differences in drug use;