Purity of Medicinal Products
Research output: Contribution to journal › Journal article › Research › peer-review
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Purity of Medicinal Products. / Jensen, Birgit Sólvkær; Knudsen, Lisbeth Ehlert; Petersen, Poul Vibholm.
In: Therapeutic Innovation & Regulatory Science, Vol. 34, No. 3, 2000, p. 895-902.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Purity of Medicinal Products
AU - Jensen, Birgit Sólvkær
AU - Knudsen, Lisbeth Ehlert
AU - Petersen, Poul Vibholm
PY - 2000
Y1 - 2000
N2 - This paper provides some general views on the current guidelines on the purity of medicinal products, with the purpose of informing the medicinal industry about the Danish Medicines Agency's view on how to establish requirements on impurities in chemically-synthesised active substances (the Danish Medicine Agency's rules of thumb do not cover nonchemical substances) and medicinal products for human use. It should be emphasized that the points of views represent the Danish Medicines Agency's interpretation of the quality guidelines in question.
AB - This paper provides some general views on the current guidelines on the purity of medicinal products, with the purpose of informing the medicinal industry about the Danish Medicines Agency's view on how to establish requirements on impurities in chemically-synthesised active substances (the Danish Medicine Agency's rules of thumb do not cover nonchemical substances) and medicinal products for human use. It should be emphasized that the points of views represent the Danish Medicines Agency's interpretation of the quality guidelines in question.
KW - Danish Medicines Agency
KW - Medicinal products
KW - Purity
UR - http://www.scopus.com/inward/record.url?scp=84996235009&partnerID=8YFLogxK
U2 - 10.1177/009286150003400325
DO - 10.1177/009286150003400325
M3 - Journal article
AN - SCOPUS:84996235009
VL - 34
SP - 895
EP - 902
JO - Therapeutic Innovation & Regulatory Science
JF - Therapeutic Innovation & Regulatory Science
SN - 2168-4790
IS - 3
ER -
ID: 343210685