Bioanalytical Procedures



-        To acquire knowledge and skills in Analytical Biochemistry and related procedures

-        To know the bioanalytical methods (spectrophotometry, chromatography, electrophoresis and ELISA) used to quantify and/or characterize drugs and compounds in biological matrices.

-        To introduce methodologies for sample preparation in trace analysis

-        To be able to implement and develop bioanalytical methods.

-        To know the validation parameters, perform validation plans and conclude on the validity of bioanalytical methods.

-        To be familiar with the basic aspects of regulation, quality control and quality systems.

-        To be able to search and critically interpret the literature in this field.

General characterization





Responsible teacher

Ana Maria de Jesus Bispo Varela Coelho


Weekly - 4

Total - 44

Teaching language





-       F Settle. Handbook of Instrumental Techniques for Analytical Chemistry. Prentice Hall PTR, 1997.

-        MM Cox, GN Phillips, Jr. Handbook of proteins – Structure, function and methods. Volume 2. Wiley, 2007.

-        D Sheehan. Physical Biochemistry: Principles and Applications, 2nd Edition, Wiley, 2009

-        F Garofol. Bioanalytical Method Validation, in Analytical Method Validation and Instrument Performance Verification (eds C. C. Chan, H. Lam, Y. C. Lee and X.-M. Zhang), John Wiley & Sons, Inc., Hoboken, NJ, USA. 2004

-P Nethercote, J Ermer. Analytical Validation within the Pharmaceutical Lifecycle, Wiley-VCH Verlag GmbH & Co, 2014

Teaching method

This curricular unit includes lectures, tutorials and practical laboratory classes. The lectures classes will be given using “data show”, together with complementary bibliography made available at the Web page of the curricular unit.

Tutorial classes: resolution of problems, literature search, study and discussion of plans for methods validation and of their results.

Laboratory practical classes: experimental work following provided protocols and integrated in the curriculum of actual UC and in Integrated Laboratories I.

Attendance of the curricular unit: mandatory for 2/3 of the total tutorial and lab classes.

Evaluation method


  • 2 individual tests (45% and 25%)
  • Validation plan and report for a bioanalytical method (15%/group)
  • Discussion of the validation report (15%)

Subject matter

  1. Introduction to Analytical Biochemistry.
  2. Bioanalytical methods relevant for the quantification and/or characterization of drugs, metabolites and other compounds in biological matrices.
  3. Strategies for the development and implementation of bioanalytical methods.
  4. Validation of bioanalytical methods.
  1. Introduction to regulation, quality control and quality systems in the Clinical Biochemistry Laboratory


Programs where the course is taught: