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
Open this folder and view contentsPart Two. Equivalence studies needed for marketing authorization
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
 

References

1. Annex 1C. Article 39. In: Marrakesh Agreement Establishing the World Trade Organization. Marrakesh, GATT, 1994.

2. Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992:14-79 (WHO Technical Report Series, No. 823).

3. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-first report. Geneva, World Health Organization, 1990:64-79 (WHO Technical Report Series, No. 790).

4. The use of essential drugs. Model List of Essential Drugs (Seventh List). Fifth report of the WHO Expert Committee. Geneva, World Health Organization, 1992:62-74 (WHO Technical Report Series, No. 825).

5. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. In: The use of essential drugs. Sixth report of the WHO Expert Committee. Geneva, World Health Organization, 1995:97-137 (WHO Technical Report Series, No. 850).

6. Good laboratory practices in governmental drug control laboratories. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirtieth report. Geneva, World Health Organization. 1987: 20-35 (WHO Technical Report Series, No. 748).

7. Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. International journal of clinical pharmacology, therapy and toxicology, 1991, 29:1-8.

8. Hauschke D et al. Sample size determination for bioequivalence assessment using a multiplicative model. Journal of pharmacokinetics and biopharmaceutics, 1992, 20:559 - 563.

9. Phillips KE. Power of two one-sided tests procedure in bioequivalence. Journal of pharmacokinetics and biopharmaceutics, 1990, 18:137-144.

10. Conference report on analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Journal of pharmaceutical sciences, 1992, 81:309 - 312.

11. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of pharmacokinetics and biopharmaceutics, 1987, 15:657-680.

12. Hauschke D et al. A distribution-free procedure for the statistical analysis of bioequivalence studies. International journal of clinical pharmacology, therapy and toxicology, 1990, 28:72-78.

13. Hollander M, Wolfe DA. Nonparametric statistical methods. New York, John Wiley, 1973:35-38.

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: June 25, 2014