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Chapter 57 : Clinical Quality Assurance and the International Development of New Anti-Infective Agents

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Clinical Quality Assurance and the International Development of New Anti-Infective Agents, Page 1 of 2

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Abstract:

This chapter analyzes the specific features of the clinical development of anti-infective agents (AIA) (antibacterials, antivirals, and antifungals) and identifies the general or specific rules for obtaining optimal quality. It discusses quality assurance (QA) of clinical trials on medical products, and problems posed by clinical evaluation of AIA. The only means of evaluating and improving the quality of French clinical trials will be (i) the official institution of inspections (medical and pharmaceutical inspectors) by the French authorities and (ii) the possible inspection by the FDA, the ideal in the future being the mutual recognition by the United States, Europe, and Japan of clinical trials after inspection by local authorities; this would require the prior institution of a system of inspection within the framework of the European Union. Total quality is an aim to be achieved in clinical research for any pharmaceutical company. The absence of standards in clinical bacteriology makes the systematic introduction of good laboratory practice (GLP) and clinical QAS within a short period a matter of necessity. Only a stricter methodological approach will allow the efficacy of AIA to be correctly evaluated but will also allow an intercenter comparison in the main countries of the world.

Citation: Husson J, Lim C, Bryskier A. 2005. Clinical Quality Assurance and the International Development of New Anti-Infective Agents, p 1371-1377. In Bryskier, M.D. A (ed), Antimicrobial Agents. ASM Press, Washington, DC. doi: 10.1128/9781555815929.ch57
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Figures

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Figure 1

The different partners involved in a clinical trial. Authorities: FDA, Koseisho, national agencies (France, Sweden, United Kingdom, Germany). ICF, informed-consent form; SOP, standard operating procedures; EMEA, European Agency for the Evaluation of Medicinal Products.

Citation: Husson J, Lim C, Bryskier A. 2005. Clinical Quality Assurance and the International Development of New Anti-Infective Agents, p 1371-1377. In Bryskier, M.D. A (ed), Antimicrobial Agents. ASM Press, Washington, DC. doi: 10.1128/9781555815929.ch57
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References

/content/book/10.1128/9781555815929.ch57
1. Beam TR,, David NG,, Kunin CI, 1992, General guidelines for the clinical evaluation of anti-infective drug products, Clin Infect Dis, 15 (Suppl 1), S5-S33.
2. D’Arcy PF,, Harron DWG, ed, 1991, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Proceedings of the 1st International Conference on Harmonization, Brussels, vol. I.
3. Regnier B, 1990, Good clinical practice, Eur J Clin Microbiol Inf Dis, 9, 519-522.

Tables

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Table 1

Treatment by AIA: characteristics in relation to other medicinal products in therapeutic and quality terms

Citation: Husson J, Lim C, Bryskier A. 2005. Clinical Quality Assurance and the International Development of New Anti-Infective Agents, p 1371-1377. In Bryskier, M.D. A (ed), Antimicrobial Agents. ASM Press, Washington, DC. doi: 10.1128/9781555815929.ch57
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Table 2

Development by the FDA of GCP

Citation: Husson J, Lim C, Bryskier A. 2005. Clinical Quality Assurance and the International Development of New Anti-Infective Agents, p 1371-1377. In Bryskier, M.D. A (ed), Antimicrobial Agents. ASM Press, Washington, DC. doi: 10.1128/9781555815929.ch57
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Table 3

List of essential documents for clinical trials conducted in accordance with GCP (proposal)

Citation: Husson J, Lim C, Bryskier A. 2005. Clinical Quality Assurance and the International Development of New Anti-Infective Agents, p 1371-1377. In Bryskier, M.D. A (ed), Antimicrobial Agents. ASM Press, Washington, DC. doi: 10.1128/9781555815929.ch57
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Table 4

Routine FDA inspections–the most common deficiencies a

Citation: Husson J, Lim C, Bryskier A. 2005. Clinical Quality Assurance and the International Development of New Anti-Infective Agents, p 1371-1377. In Bryskier, M.D. A (ed), Antimicrobial Agents. ASM Press, Washington, DC. doi: 10.1128/9781555815929.ch57
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Table 5

Comparison of site audits undertaken in France and the United Kingdom a

Citation: Husson J, Lim C, Bryskier A. 2005. Clinical Quality Assurance and the International Development of New Anti-Infective Agents, p 1371-1377. In Bryskier, M.D. A (ed), Antimicrobial Agents. ASM Press, Washington, DC. doi: 10.1128/9781555815929.ch57
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Table 6

Background documentation required for clinical trials of a new medicinal product and registration

Citation: Husson J, Lim C, Bryskier A. 2005. Clinical Quality Assurance and the International Development of New Anti-Infective Agents, p 1371-1377. In Bryskier, M.D. A (ed), Antimicrobial Agents. ASM Press, Washington, DC. doi: 10.1128/9781555815929.ch57

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