The European Clinical Trials Directive - A regulatory approach for filing drug substance information

Drug Development and Industrial Pharmacy

Volumn 31, Issue 8, 2005, Pages 709-718

  Lettani, Debbie ^a   DiFeo, Thomas J ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ANALYTIC METHOD; CLINICAL TRIAL; DRUG IMPURITY; DRUG MANUFACTURE; DRUG NOMENCLATURE; DRUG QUALITY; DRUG STABILITY; DRUG STRUCTURE; EUROPE; EVALUATION; GOOD MANUFACTURING PRACTICE; HUMAN; MATERIALS; PRACTICE GUIDELINE; PROCESS CONTROL; PROCESS DESIGN; PUBLICATION; REVIEW; ARTICLE; CHEMISTRY; DRUG FORMULATION; EUROPEAN UNION; LEGAL ASPECT;

CHEMISTRY, PHARMACEUTICAL; CLINICAL TRIALS; DRUG COMPOUNDING; DRUG STABILITY; DRUGS, INVESTIGATIONAL; EUROPEAN UNION;

EID: 25144449527     PISSN: 03639045     EISSN: None     Source Type: Journal    
DOI: 10.1080/03639040500217913     Document Type: Review

References (23)

1. Brittain, H. G., Bogdanowich, S. J., Bugay, D. E., DeVincentis, J., Lewen, G., & Newman, A. W. (1991). Physical characterization of pharmaceutical solids. Pharmaceutical Research, 8(8), 963-973.
2. Committee for Proprietary Medicinal Products (CPMP) (December 17, 2002). Note for Guidance on Specification Limits for Residues of Metal Catalysts. 1-23, http://www.emea.eu.int/pdfs/human/swp/ 444600en.pdf (accessed December 2004).
3. Doyle, T. D., Brunner, C. A., & Hunt, R. L. (1997). Development of chiral methods. In: S. Ahuja (Ed.), Chiral Separations (pp. 155-172). Washington, DC: American Chemical Society.
4. European Commission, Enterprise Directorate-General (April 2004). Detailed Guidance for the Request for Authorisation of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authorities, Notification of Substantial Amendments and Declaration of the End of the Trial: 1-44. Revision 1; http:// pharmacos.eudra.org/F2/pharmacos/docs/Doc2004/april/ cp%20and%20guidance%20CA%20rev%2028%20Apr% 2004%20Final%20.pdf (accessed December 2004).
5. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) (December 16, 2004). Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials, 1-32. http://www.emea.eu.int/Inspections/docs/ 18540104en.pdf (accessed January 2005).
6. European Pharmacopoeia (September 20, 2001). I. Preface (4th Ed.), i-ii. http://www.pheur.org/site/page_dynamique.php3?lien=M&lien_page=6&id=5 (accessed December 2004).
7. Griesser, U. J., & Burger, A, (1993). The polymorphic drug substances of the European Pharmacopeia. Part 8. Thermal-analytical and FTIR-microscopic investigations of etofyllin crystal forms. Scientia Pharmaceutica, 61(2), 133-143.
8. International Conference on Harmonization of Technical Requirements For Registration of Pharmaceuticals for Human Use (July 17, 1997). ICH harmonized tripartite guideline. In: Impurities Guideline for Residual Solvents, 1-16. Q3C, Step 4 of the ICH Process; http://www.ich.org/MediaServer.jser?@_ID= 423&@_MODE=GLB (accessed December 2004).
9. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (February 7, 2002). ICH harmonized tripartite guideline. In: Impurities in New Drug Substances, 1-11. Q3A(R), Step 4 of the ICH Process; http:// www.ich.org/UrlGrpServer.jser?@_ID= 276&@_TEMPLATE=254 (accessed December 2004).
10. Lim, C.-K., & Lord, G. (2002). Current developments in LC-MS for pharmaceutical analysis. Biological and Pharmaceutical Bulletin, 25(5), 547-557.
11. Meader, C. D. (2004). The EU clinical trials directive-a concise review. Chemistry review. Chemistry Today, 22(1/2), 33-35.
12. Official Journal of the European Communities (May 1, 2001). On the approximation of the laws, regulations, and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Directive 2001/20/EC. Official Journal of the European Communities, 44, 34-44. L121, http://europa.eu.int/eurlex/pri/en/oj/dat/2001/I_121/I_ 12120010501en00340044. pdf (accessed December 2004).
13. Official Journal of the European Communities (October 14, 2003). Laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Directive 2003/ 94/EC. Official Journal of the European Communities, 46, 22-26. L262,http://europa.eu.int/eurlex/pri/en/oj/dat/2003/I_262/ I_26220031014en00220026.pdf (accessed December 2004).
14. Pritchard, J. F., Jurima-Romet, M., Reimer, M. L. J., Mortimer, E., Rolfe, B., & Cayen, M. N. (2003). A guide to drug discovery: making better drugs: decision gates in non-clinical drug development. Nature Reviews, Drug Discovery, 2(7), 542-553.
15. Raphael, B. (2003). Statistical evaluation of stability data: criteria for change-over-time and data variability. PDA Journal of Pharmaceutical Science and Technology, 57(5), 369-377.
16. Reddy, K. V. S. R., Rao, M. S., Reddy, G. O., Suresh, T., Babu, J. M., Dubey, P. K., & Vyas, K. (2002). Isolation and characterization of process-related impurities in linezolid. Journal of Pharmaceutical and Biomedical Analysis, 30, 635-642.
17. Reffner, J. (2003). Characterization of hydrates, solvates, salts, and polymorphs in drug development using infrared microspectroscopy and thermomicroscopy. Microscope, 51(3), 107-110.
18. Rollinger, J. M., & Burger, A. (2002). Physico-chemical characterization of hydrated and anhydrous crystal forms of amlodipine besylate. Journal of Thermal Analysis and Calorimetry, 68(2), 361-372.
19. Sebag, A. B., Forsyth, D. A., & Plante, M. A. (2001). Conformation and configuration of tertiary amines via GIAO-derived 13C NMR chemical shifts and a multiple independent variable regression analysis. Journal of Organic Chemistry, 66(24), 7967-7973.
20. Streng, W. H. (1997). Physical chemical characterization of drug substances. Drug Discovery Today, 2(10), 415-426.
21. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (September 1989). Guideline for Drug Master Files. (Updated May 2004); http://www.fda.gov/cder/ guidance/dmf.htm (accessed December 2004).
22. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research (November 1995). Guidance for Industry, Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products, 1-15. http:// www.fda.gov/cder/guidance/clin2.pdf (accessed December 2004).
23. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (May 2003). INDs for Phase 2 and Phase 3 Studies, 1-24. http://www.fda.gov/ cder/guidance/3619fnl.pdf (accessed December 2004)