-
1
-
-
14544284853
-
COMMISSION DIRECTIVE 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
-
COMMISSION DIRECTIVE 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Official Journal L 2003, 159:46-94.
-
(2003)
Official Journal L
, vol.159
, pp. 46-94
-
-
-
2
-
-
29344453431
-
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
-
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. Official Journal L 2005, 91:13-19.
-
(2005)
Official Journal L
, vol.91
, pp. 13-19
-
-
-
3
-
-
84862813334
-
-
Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ L No 22 of 9. 2. ) ((As amended by Directives 66/454/EEC, 75/319/EEC, 83/570/EEC, 87/21/EEC, 89/341/EEC 89/342/EEC 89/343/EEC, 92/27/EEC, 92/73/EEC et 93/39/EEC).
-
Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ L No 22 of 9. 2. 1965, p. 369) ((As amended by Directives 66/454/EEC, 75/319/EEC, 83/570/EEC, 87/21/EEC, 89/341/EEC 89/342/EEC 89/343/EEC, 92/27/EEC, 92/73/EEC et 93/39/EEC).
-
(1965)
, pp. 369
-
-
-
4
-
-
23944507047
-
Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products
-
09/06/1975
-
Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. Official Journal L 09/06/1975, 147:1-12.
-
Official Journal L
, vol.147
, pp. 1-12
-
-
-
5
-
-
0008466679
-
Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens
-
25/05/1989
-
Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens. Official Journal L 25/05/1989, 142:14-15.
-
Official Journal L
, vol.142
, pp. 14-15
-
-
-
6
-
-
0020369574
-
Severe impairment of cholinergic and adrenergic responsiveness in Bordetella pertussis vaccinated rats
-
de Wildt D.J., Kreeftenberg J.G., Nijkamp F.P. Severe impairment of cholinergic and adrenergic responsiveness in Bordetella pertussis vaccinated rats. European Journal of Pharmacology 1982, 86(2):315-316.
-
(1982)
European Journal of Pharmacology
, vol.86
, Issue.2
, pp. 315-316
-
-
de Wildt, D.J.1
Kreeftenberg, J.G.2
Nijkamp, F.P.3
-
7
-
-
0012111484
-
Directive 2001/83/EC of the European parliament and of the council of 6 November 2001 on the Community code relating to medicinal products for human use
-
Directive 2001/83/EC of the European parliament and of the council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal L 2001, 311:67-128.
-
(2001)
Official Journal L
, vol.311
, pp. 67-128
-
-
-
17
-
-
84862813332
-
Guideline for Nonclinical Studies of Preventive Vaccines for Infectious Diseases
-
(supplementary information)
-
Guideline for Nonclinical Studies of Preventive Vaccines for Infectious Diseases. Notification of yakushokushinsahatsu No.0527-1 May 27, Japan (Japanese literature) 2010, (supplementary information).
-
(2010)
Notification of yakushokushinsahatsu No.0527-1 May 27, Japan (Japanese literature)
-
-
-
18
-
-
39649124899
-
Guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines
-
Guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines. WHO Technical Report Series No 941 2007.
-
(2007)
WHO Technical Report Series No 941
-
-
-
21
-
-
80051539192
-
The Biological IND
-
Waltham, MA, USA:Parexel, M. Mathieu (Ed.)
-
Novak J.M., Barrett J., McVittie L.D. The Biological IND. Biologics Development: A Regulatory Overview 1997, 49-81. Waltham, MA, USA:Parexel. 2nd ed. M. Mathieu (Ed.).
-
(1997)
Biologics Development: A Regulatory Overview
, pp. 49-81
-
-
Novak, J.M.1
Barrett, J.2
McVittie, L.D.3
-
22
-
-
23444460612
-
Regulation (EC) no 726/2004 of the European parliament and of the council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
-
Regulation (EC) no 726/2004 of the European parliament and of the council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official Journal L 2004, 136:1-33.
-
(2004)
Official Journal L
, vol.136
, pp. 1-33
-
-
-
23
-
-
0032192632
-
Repeated administration of whole-cell and acellular pertussis vaccines affects haemodynamics and autonomic responsiveness
-
van Amsterdam J.G., te Biesebeek J.D., van de Kuil T., van der Laan J.W., de Wildt D.J., Vleeming W. Repeated administration of whole-cell and acellular pertussis vaccines affects haemodynamics and autonomic responsiveness. Vaccine 1998, 16(17):1668-1674.
-
(1998)
Vaccine
, vol.16
, Issue.17
, pp. 1668-1674
-
-
van Amsterdam, J.G.1
te Biesebeek, J.D.2
van de Kuil, T.3
van der Laan, J.W.4
de Wildt, D.J.5
Vleeming, W.6
-
24
-
-
84862813338
-
-
Code of Federal Regulation, Title 21, Part 312, Washington, DC, US Government Printing Office http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210&showFR=1.
-
Code of Federal Regulation, Title 21, Part 312, Washington, DC, US Government Printing Office
-
-
|