The Quality Control of Medicines

Proceedings of the 35th International Congress of Pharmaceutical Sciences, Dublin, 1975

1st Edition - January 1, 1976
Editors: P.B. Deasy, R.F. Timoney
Language: English
eBook ISBN:
9 7 8 - 1 - 4 8 3 1 - 6 5 0 2 - 8

The Quality Control of Medicines documents the proceedings of the 35th International Congress of Pharmaceutical Sciences, organized by the Pharmaceutical Society of Ireland on… Read more

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The Quality Control of Medicines documents the proceedings of the 35th International Congress of Pharmaceutical Sciences, organized by the Pharmaceutical Society of Ireland on behalf of the Federation Internationale Pharmaceutique, held in Dublin, on 1-5 September 1975. The theme chosen for the Congress was ""the basis for the quality control of medicines"", because of the importance and relevance of quality control in the production and distribution of medicines at national and international levels. This volume is arranged according to the manner in which the theme of the Congress was developed by the eminent invited speakers. Following the inaugural address a main symposium was held where five speakers presented a review of the quality control of medicines under the general headings of (i) chemical and physical aspects; (ii) biological aspects; (iii) control of drug delivery systems; (iv) storage problems; and (v) problems of international control. Certain aspects of the content of the main symposium were then developed in greater depth in parallel symposia. In the first parallel symposium some novel physicochemical aspects of the quality control of medicines were treated under the headings of spectrofluorimetry, mass spectrometry, detection in gas chromatography, and automation in pharmaceutical analysis. The second parallel symposium developed certain microbiological aspects of quality control under the headings of sterility testing and microbiological control of non-sterile products and ophthalmic preparations. The final symposium on submissions to regulatory bodies and international aspects of drug control covered aspects of politics in submissions, regulatory problems in small countries, and various pharmacopoeial problems.

Introduction

List of contributors

Inaugural address

The quality control of medicines: A national and international responsibility

Main symposium. The basis for the quality control of medicines

1. Chemical and physical aspects of the control of medicines

2. Biological aspects of the control of medicines

3. New concepts and standards of quality control as applied to controlled drug delivery systems

4. Storage problems associated with the control of medicines

5. Problems of international control of medicines

Parallel symposia

1. Physicochemical analysis

6. Spectral methods and in particular spectrofluorimetry

7. The uses of mass spectrometry in the quality control of drugs

8. Microwave discharge and afterglow excited emission spectra for detection in gas chromatography

9. Automation in pharmaceutical analysis

2. Microbiological aspects

10. Testing procedures for sterile products

11. Microbiological aspects in the control of non-sterile products

12. Preservation and sterility of ophthalmic preparations and devices

3. Bioavailability testing

13. Bioavailability testing in man; pharmacokinetic considerations

14. Bioavailability testing in man; pharmacological and clinical measurements

15. Analytical problems in bioavailability testing

16. In vitro studies on the dissolution and absorption behavior of orally administered drugs and the connection to their bioavailability

17. Bioavailability: a challenge to the standard concept of regulating the quality of drug products by published monographs

4. Separation techniques

18. Ion-pair and complex extraction of organic compounds

19. Detection and estimation of impurities by thin-layer chromatography

20. Problems relating to the interpretation of spectroscopic data in the presence of degradation product

21. Adsorption problems in preparative and analytical liquid chromatography

5. Submissions to regulatory bodies and international aspects of drug control

22. Politics in submissions

23. Drug regulatory problems in smaller countries

24. The field of application of pharmacopoeias

25. The function of pharmacopoeia standards

Subject index