WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Close this folder2. The international pharmacopoeia and related activities
View the document2.1. Quality specifications for drug substances and dosage forms
View the document2.2. Dissolution test for solid oral dosage forms: paddle method
View the document2.3. Therapeutic equivalence of multisource products
View the document2.4. International nonproprietary names for pharmaceutical substances
Open this folder and view contents3. International Chemical Reference Substances and International Infrared Reference Spectra
View the document4. Quality control methods for medicinal plant materials
View the document5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contents6. Good manufacturing practices for pharmaceutical products
View the document7. Development of globally acceptable standards for excipients
Open this folder and view contents8. Stability of dosage forms
View the document9. Simple test methodology
View the document10. Quality assurance in pharmaceutical supply systems
Open this folder and view contents11. Pharmaceutical production in developing countries
View the document12. Training
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 - List of available International Chemical Reference Substances1
View the documentAnnex 2 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 3 - Good manufacturing practices for biological products1
View the documentBack Cover

2.3. Therapeutic equivalence of multisource products

While the inclusion of dissolution requirements in The international pharmacopoeia was considered to be an important step forward, it was recognized that an in vitro dissolution test was only one stage in the procedure for ensuring that multisource products were therapeutically equivalent. Information on the interchangeability of conventional-release solid dosage forms from a wide range of sources, all containing the same quantity of the same active ingredient, was essential for those responsible for approving the registration of products.

It was recognized that existing national regulatory requirements varied with respect to multisource products and that a need therefore existed for global guidelines. It was suggested that WHO, among other appropriate activities, might:

- undertake a survey of national legislation and practices with regard to registration requirements, and the prescribing and dispensing in retail pharmacies of multisource products;

- compile and review at regular intervals a list of drug substances that may be associated with bioavailability problems (including those of narrow therapeutic index, etc.);

- collect and compile available information on the correlation between activity in vivo and in vitro for essential drugs presenting problems (reported, for example, via drug monitoring services) of bioavailability and bioequivalence;

- develop WHO guidelines for bioequivalence studies, in the context of the WHO guidelines on good clinical practices currently in course of preparation;

- establish a policy and recommendations with regard to the role of dissolution testing in the quality control of drugs and in determining whether they are therapeutically equivalent.


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