Scientific Biomedical Communication

Definition of the course's goals, general and molecular pharmacology. Definition of drug. Outline of preclinical and clinical pharmacological experimentation. Pharmacokinetics, Drug Administration Routes, Drug Absorption, Drug Distribution, Drug Elimination by Metabolism, Dosage Planning and Optimization. Link with serum proteins, concept and definition of clearance, apparent volume of distribution, half-life, AUC parameter, definition of efficacy and potency of a drug. Therapeutic index, value of the EC50 and handling of a drug. Steady state, accumulation, first pass metabolism and enteropathic shunt. Factors that determine the greater tendency to accumulate drugs. Lipophilicity and partition coefficient. Pharmacological approach aimed at improving the bioavailability of a drug. Pharmacodynamics: drug / receptor interaction, classification of the different receptor families and different signal transduction mechanisms. Dose / response relationships, definition of biological effect. Pharmacokinetic, pharmacodynamic and chemical interactions between drugs. Pharmacoallergy and drug-idiosicrasia. Concept of adverse drug reactions, reporting and general classification of ADRs. General organization of sympathetic and parasympathetic neurotransmission systems, non-adrenergic-non-cholinergic system (NANC), role of NO, general lines. Classification, structure and mechanism of cholinergic, adrenergic transmission and examples of other neurotransmission and their receptors. 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.

Definition of the course's goals, general and molecular pharmacology. Definition of drug. Outline of preclinical and clinical pharmacological experimentation. Pharmacokinetics, Drug Administration Routes, Drug Absorption, Drug Distribution, Drug Elimination by Metabolism, Dosage Planning and Optimization. Link with serum proteins, concept and definition of clearance, apparent volume of distribution, half-life, AUC parameter, definition of efficacy and potency of a drug. Therapeutic index, value of the EC50 and handling of a drug. Steady state, accumulation, first pass metabolism and enteropathic shunt. Factors that determine the greater tendency to accumulate drugs. Lipophilicity and partition coefficient. Pharmacological approach aimed at improving the bioavailability of a drug. Pharmacodynamics: drug / receptor interaction, classification of the different receptor families and different signal transduction mechanisms. Dose / response relationships, definition of biological effect. Pharmacokinetic, pharmacodynamic and chemical interactions between drugs. Pharmacoallergy and drug-idiosicrasia. Concept of adverse drug reactions, reporting and general classification of ADRs. General organization of sympathetic and parasympathetic neurotransmission systems, non-adrenergic-non-cholinergic system (NANC), role of NO, general lines. Classification, structure and mechanism of cholinergic, adrenergic transmission and examples of other neurotransmission and their receptors. 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.