Module 3. Principal Groups of Xenobiotics

Module 3: Principal Groups of Xenobiotics

Date of release/last update: created 22-04-2016, last update 04-12-2017

Authors

• Roberto Mandrioli (UniBo)
  
• Stefano Girotti (UniBo)
  
• Luigi Guerra (UniBo)
  
• Laura Mercolini (UniBo)
  
• Michele Protti (UniBo)
  
• Luca Ferrari (UniBo)
  

Short descriptions

This module describes the main toxicological characteristics of prescription and abuse drugs, and their differences from legal and scientific points of view. Analytical methods for their qualitative and quantitative determination in different biological and non-biological matrices will be described and discussed. The most important aspects of regulations in the pharmaceutical sector will be provided and explained.

Intended learning outcomes       

At the end of this module, the learner should be able to:

• describe the main sources and contents of regulations in the pharmaceutical sector;
  
• identify, understand and follow GLP and GMP;
  
• understand the difference between prescription drugs and abuse drugs;
  
• know and identify the most important toxicological effects of drugs;
  
• find, understand, evaluate and use scientific and official publications to analyze different kinds of pharmaceutical and toxic substances;
  
• apply the information received to a forensic setting.
  

For each class of abuse and prescription drugs, the student should be able to:

• Cite and identify the main members of the class;
  
• Hypothesize one or more possible analytical strategies that could be suitable for most drugs in the class;
  
• Search the literature and find relevant papers and guidelines for the sampling, sample pre-treatment and analysis of the drugs belonging to the class;
  
• Participate in, and contribute to, decisional processes and practical work related to forensic and other highly regulated analytical fields;
  
• Actively participate in certification and accreditation procedures.
  

Module structures

3.1 Prescription drugs (2 ECTS)

• Toxicology
  
• Forensic analysis
  
• Case reports
  
• Pharmaceutical sector regulation: GLP, GMP, certification, accreditation, ICH, case studies
  

3.2 Drugs of abuse (2 ECTS)

• Drug toxicology
  
• Forensic analysis
  
• Case reports

Estimated workload        

4 ECTS: 112 hours

Audience              

Students in the health professions, physicians, hygienists, chemists, pharmacists.

Available languages          

Basic language - English. Then translation into native languages of each author

(Italian) and into the languages of of all involved countries ( Spanish, Portuguese, Czech, Romanian, Bulgarian, Finnish).