Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Close this folder1. National drug regulation
Close this folderGuiding principles for small national drug regulatory authorities1,2
Open this folder and view contents1. General considerations
Open this folder and view contents2. Administrative aspects of the licensing process
Close this folder3. Technical aspects of the licensing process
View the document3.1 General considerations
View the document3.2 Products containing long-established chemical entities
View the document3.3 Products containing new chemical entities
View the document3.4 Herbal products
View the document3.5 Combinations of potent, therapeutically active substances
View the document3.6 Generic products
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 
3.5 Combinations of potent, therapeutically active substances

The justifications for formulating fixed combinations of potent, therapeutically active substances are few. All biologically active substances have a potential to induce harm as well as therapeutic benefit. The administration of two or more such substances, rather than one, increases the potential for adverse effects. Fixed-ratio combination products are consequently acceptable only when the dosage of each ingredient meets the requirements of a defined population group and when use of the combination provides a clear advantage over separate administration of the individual active compounds, in either therapeutic effect or compliance, or when it enhances safety - as in the case of multiple chemotherapy intended to reduce the emergence of resistant pathogens.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: October 7, 2014