http://corsidilaurea.uniroma1.it/en/insegnamento/446724
The course will cover a range of aspects of drug development including pharmacology, target identification, safety requirements.
Topics include:
• Basic concepts of drug discovery and testing.
• Pre-clinical phase: pharmacological, toxicological and pharmacokinetics investigations in animal and in vitro testing.
• The phases of clinical development: determination of the safety and effectiveness of a new drug in humans.
• Postmarketing surveillance, its role in the detection of adverse drug reactions.
PROGRAM: Stages of development of a drug-medicament. Identification of a new drug
target. Evaluation of clinical candidates: pharmacodynamic activity of a
new molecular entity. Pharmacogenomics in drug development.
Pharmacological
studies pre-clinical studies. Main methods in vitro and in vivo. Good
laboratory practices. Pharmacodynamic activity versus toxicity:
Pre-clinical studies to assess the safety of a drug.
Medications and
Pregnancy: teratogenic drug. Issues related to the presence of genotoxic
and non genotoxic impurities and in medicinal products.
Types of
clinical trials. Phases of clinical trials. Good clinical practice. Role
of ethics committees. The Investigator's brochure. Registration of
drugs at national and European level.
Pharmacovigilance: definition and tasks. Methods used in pharmacovigilance.
Definition and classification of adverse drug reactions.
The course will cover a range of aspects of drug development including pharmacology, target identification, safety requirements.
Topics include:
• Basic concepts of drug discovery and testing.
• Pre-clinical phase: pharmacological, toxicological and pharmacokinetics investigations in animal and in vitro testing.
• The phases of clinical development: determination of the safety and effectiveness of a new drug in humans.
• Postmarketing surveillance, its role in the detection of adverse drug reactions.
PROGRAM: Stages of development of a drug-medicament. Identification of a new drug
target. Evaluation of clinical candidates: pharmacodynamic activity of a
new molecular entity. Pharmacogenomics in drug development.
Pharmacological
studies pre-clinical studies. Main methods in vitro and in vivo. Good
laboratory practices. Pharmacodynamic activity versus toxicity:
Pre-clinical studies to assess the safety of a drug.
Medications and
Pregnancy: teratogenic drug. Issues related to the presence of genotoxic
and non genotoxic impurities and in medicinal products.
Types of
clinical trials. Phases of clinical trials. Good clinical practice. Role
of ethics committees. The Investigator's brochure. Registration of
drugs at national and European level.
Pharmacovigilance: definition and tasks. Methods used in pharmacovigilance.
Definition and classification of adverse drug reactions.
- Docente: SILVANA GAETANI