The Quality of Antimalarials - A Study in Selected African Countries - EDM Research Series No. 030
(2003; 67 pages) View the PDF document
Table of Contents
View the documentAuthors
View the documentCountry Research Team Leaders
View the documentLaboratory Support
View the documentAcknowledgements
View the documentAcronyms
View the documentExecutive summary
View the document1. Background
Open this folder and view contents2. Methodology
View the document3. Results
Open this folder and view contents4. Discussion
Close this folder5. Conclusions and recommendations
View the document5.1 Conclusions
View the document5.2 Need for further studies
View the document5.3 Recommendations for further studies
View the document5.4 Recommendations for quality and bio-equivalence surveillance
View the documentReferences
Open this folder and view contentsTables
Open this folder and view contentsAnnexes
View the documentOther documents in the EDM Research Series
View the documentEDM Research Series No. 30
 

5.3 Recommendations for further studies

This pilot study was conducted as a prelude to a comprehensive study on the quality of antimalarials and the complex issues involved. The critical methodological and analytical considerations highlighted in this report should be taken into account when planning further studies. This means:

• Working closely with the analytical laboratory during the planning phase of such a study in order to accommodate the analytical laboratory's needs regarding sample and analytical information, sample containers, and the quantities of sample needed.

• Products should not be taken from the original packaging material in which they are marketed. The use of other packaging material than that used by the manufacturer for sampling may compromise the integrity of the product.

• The storage and transport of samples after sampling should be validated to assure the stability of the samples.

• A standard operational procedure should be used to guide sampling and handling of sampled products in order to standardize procedures in all countries. Where possible, the formulation of the product and/or the analytical method that the manufacturer uses for batch release should be made available to the analytical laboratory. This is in order to assure the specificity of the analytical method to be employed by the testing laboratory.

• More emphasis should be given to dissolution of solid dosage forms, as this gives an indication of the pharmaceutical availability and interchangeability of products.

• Tests for preservative efficacy should be considered for liquid dosage forms.

 

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