| Course name |
Industrial pharmacy |
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| Study-unit Code |
A003599 |
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| Curriculum |
Comune a tutti i curricula |
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| Lecturer |
Marco Gargaro |
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| Lecturers |
- Marco Gargaro
- Giorgia Manni (Codocenza)
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| Hours |
- 69 ore - Marco Gargaro
- 45 ore (Codocenza) - Giorgia Manni
|
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| CFU |
6 |
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| Course Regulation |
Coorte 2023 |
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| Supplied |
2025/26 |
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| Supplied other course regulation |
|
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| Learning activities |
Caratterizzante |
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| Area |
Discipline biologiche e farmacologiche |
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| Sector |
BIO/14 |
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| Type of study-unit |
Obbligatorio (Required) |
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| Type of learning activities |
Attività formativa monodisciplinare |
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| Language of instruction |
Italian |
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| Contents |
Experimental pharmacological basis for the development of new drugs. Principles of evaluation of drug efficacy and toxicity; preclinical and clinical experimentation. Cloning and validation of a drug target. |
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| Reference texts |
Farmacologia generale e molecolare, Clementi e Fumagalli, Edra Metodologie biochimiche e biomolecolari, Maccarone, Zanichelli. Tecniche e metodi per la biologia molecolare, Plevani, Pesole, benedetti, Amaldi, Cea. Metodologie di farmacologia sperimentale, Rosalinda Sorrentino, 2022. |
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| Educational objectives |
The course in Experimental Pharmacology and Toxicology aims to provide students with the theoretical and practical knowledge necessary to understand and apply the main approaches used in preclinical research and drug development. Specifically, students will acquire: - knowledge of methods for evaluating drug efficacy and toxicity, - skills in the use of biotechnological tools (e.g., recombinant DNA) for the construction and validation of pharmacological targets; - the ability to design and perform in vitro experiments in the field of experimental pharmacology and toxicology; - a critical understanding of the phases and principles governing preclinical and clinical experimentation, with attention to ethical, regulatory, and methodological aspects. Students will be able to interpret experimental results in a pharmacological and toxicological context and translate them into therapeutic development hypotheses, gaining independent judgment skills useful for future research activities or for access to advanced training programs. |
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| Prerequisites |
To understand and apply the experimental procedures described in the Experimental Pharmacology and Toxicology course, students must have successfully passed the exam in Pharmacology, Pharmacognosy and Pharmacotherapy I. This exam is also a prerequisite for attending the practical module of Experimental Pharmacology and Toxicology. In addition, to follow the practical course effectively, it is recommended that students have a solid background in molecular biology and sufficient mathematical skills to perform calculations related to bioequivalence and dilution. |
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| Teaching methods |
The Experimental Pharmacology and Toxicology course is organized as follows: - Classroom lectures covering all the topics included in the syllabus (theoretical part); - Practical sessions: the practical course is delivered as an intensive three-week module, during which students carry out a mini experimental project focused on the design and validation of a pharmacological target, applying recombinant DNA technology and the principles of experimental pharmacology and toxicology. The practical sessions take place in the biochemical-pharmacological teaching laboratory located at the teaching facility in Via del Giochetto. |
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| Other information |
Mandatory attendance |
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| Learning verification modality |
The exam consists of oral test, an interview of about 20 minutes for evaluating the knowledge level and the ability of the student to manage the acquired experimental knowledge in a pharmacologic context. Students with disabilities and/or DSA are invited to visit the page dedicated to the tools and measures envisaged and to agree in advance what is necessary with the teacher (https://www.unipg.it/disabilita-e -dsa). |
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| Extended program |
Theoretical part: General principles of drug discovery: why and how new drugs are developed; the contribution of molecular biology; in silico drug discovery; drug development pipeline; GLP (Good Laboratory Practice), GCP (Good Clinical Practice), and GMP (Good Manufacturing Practice). ADMET studies, both in vitro and in vivo. The enzyme IDO as a pharmacological target: mechanism of action and therapeutic potential. End-point, real-time, and digital PCR as tools to evaluate pharmacological effects on gene transcription. High-throughput screening (HTS) as a method to identify lead compounds. Microarrays as a transcriptomics-based technique for preclinical drug testing. Preclinical experimentation in vitro and ex vivo: cell cultures and isolated organs; next-generation in vitro systems; methods for studying signal transduction and identifying potential pharmacological targets. In vivo preclinical experimentation: the 3Rs principle (Replacement, Reduction, Refinement); alternative methods to animal use; laboratory animals (inbred, outbred, hybrid strains); regulations for in vivo experimentation and animal housing; Irwin’s test; experimental models (spontaneous, behavioral, biologically induced, pharmacologically induced, surgically induced); oncological models, including the “oncomouse”; experimental models for diabetes; genetically modified models: generation of transgenic, knock-out, knock-in, and conditional transgenic/knock-out mice. Clinical experimentation: regulations governing clinical trials, trial protocols, scientific hypothesis, primary and secondary endpoints, patient selection criteria, known sources of variability, confounding factors (bias), controlled clinical studies, sample randomization, blinded studies, and the use of placebo. Phases of clinical trials: objectives and methodologies. Principles of biostatistics: biological populations and the concept of biological variability, clinical and statistical hypotheses, significance tests, type I and II errors, and study power. Principles of vaccinology and strategies for the development of anti-COVID vaccines. Genetically modified organisms (GMOs): advantages and challenges of biotech crops, biotech oral vaccines, transgenic animals as bioreactors, recombinant drugs. MicroRNAs as new pharmacological targets. Practical part: Cloning, expression, and validation of a pharmacological target: the enzyme IDO. In vitro purification and activation of murine splenocytes. RNA extraction, reverse transcription into cDNA, and PCR amplification of the IDO coding sequence. Insertion of the IDO coding sequence into an expression vector. Bacterial transformation and screening of bacterial colonies. Transfection of eukaryotic cells to achieve protein expression of IDO. Verification of IDO expression by polyacrylamide gel electrophoresis and Western blot. Analysis of IDO’s catalytic activity via kynurenine assay. Construction of dose–response curves using compounds acting on the IDO pharmacological target. |
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| Obiettivi Agenda 2030 per lo sviluppo sostenibile |
Goal 3: health and well-being. |
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