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
Open this folder and view contents1. National drug regulation
Close this folder2. Product assessment and registration
View the documentGuidelines for the assessment of herbal medicines1,2
Open this folder and view contentsStability of drug dosage forms1
Open this folder and view contentsGuidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
Close this folderMultisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability1
View the documentIntroduction
View the documentGlossary
Open this folder and view contentsPart One. Regulatory assessment of interchangeable multisource pharmaceutical products
Close this folderPart Two. Equivalence studies needed for marketing authorization
View the document7. Documentation of equivalence for marketing authorization
View the document8. When equivalence studies are not necessary
View the document9. When equivalence studies are necessary and types of studies required
Open this folder and view contentsPart Three. Tests for equivalence
View the documentPart Four. In vitro dissolution tests in product development and quality control
View the documentPart Five. Clinically important variations in bioavailability leading to non-approval of the product
View the documentPart Six. Studies needed to support new post-marketing manufacturing conditions
View the documentPart Seven. Choice of reference product
View the documentAuthors
View the documentReferences
View the documentAppendix 1. Examples of national requirements for in vivo equivalence studies for drugs included in the WHO Model List of Essential Drugs (Canada, Germany and the USA, December 1994)
View the documentAppendix 2. Explanation of symbols used in the design of bioequivalence studies in humans, and commonly used pharmacokinetic abbreviations
View the documentAppendix 3. Technical aspects of bioequivalence statistics
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
 
8. When equivalence studies are not necessary

The following types of multisource pharmaceutical products are considered to be equivalent without the need for further documentation:

(a) products to be administered parenterally (e.g. by the intravenous, intramuscular, subcutaneous or intrathecal route) as aqueous solutions that contain the same active substance(s) in the same concentration(s) and the same excipients in comparable concentrations;

(b) solutions for oral use that contain the active substance in the same concentration and do not contain an excipient that is known or suspected to affect gastrointestinal transit or absorption of the active substance;

(c) gases;

(d) powders for reconstitution as a solution when the solution meets either criterion (a) or criterion (b) above;

(e) otic or ophthalmic products prepared as aqueous solutions that contain the same active substance(s) in the same concentration(s) and essentially the same excipients in comparable concentrations;

(f) topical products prepared as aqueous solutions that contain the same active substance(s) in the same concentration(s) and essentially the same excipients in comparable concentrations;

(g) inhalation products or nasal sprays that are administered with or without essentially the same device, are prepared as aqueous solutions, and contain the same active substance(s) in the same concentration(s) and essentially the same excipients in comparable concentrations. Special in vitro testing should be required to document comparable device performance of the multisource inhalation product.

For requirements (e), (f) and (g) above, it is incumbent on the applicant to demonstrate that the excipients in the multisource product are essentially the same as, and are present in concentrations comparable to, those in the reference product. If this information about the reference product cannot be provided by the applicant, and the drug regulatory authority does not have access to these data, in vivo studies should be performed.

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