Analysis and study of hydrolytic resistance of sarcolysine in pharmaceutical form for injection by means of HPLC

1994 ◽  
Vol 28 (11) ◽  
pp. 860-865
Author(s):  
O. V. Yatsevich ◽  
A. P. Arzamastsev ◽  
Yu. V. Stukalov ◽  
N. I. Zimakova ◽  
É. Ya. Khaidukov
Keyword(s):  
Pharmaceutical Form ◽  
Hydrolytic Resistance ◽  
Analysis And Study

Development of tablets, as a pharmaceutical form, from comprimata to compressi – note II

Farmacist ro ◽  
2019 ◽  
Vol 3 (188) ◽  
pp. 38
Author(s):  
Alexandra Bujor ◽  
Mousa Sha’at ◽  
Andreea Crețeanu ◽  
Monica Creţan Stamate ◽  
Lăcrămioara Ochiuz
Keyword(s):  
Pharmaceutical Form

Alternativas farmacéuticas: ¿pueden ser intercambiables?

2020 ◽  
Vol 2 (2) ◽  
pp. 38-42
Author(s):  
Miriam del Carmen Carrasco-Portugal ◽  
Francisco Javier Flores-Murrieta
Keyword(s):  
Generic Substitution ◽  
In Vivo Studies ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Reference Formulation ◽  
Active Moiety ◽  
Significant Difference ◽  
Pharmaceutical Form ◽  
Extent Of Absorption

Pharmaceutical alternatives are products with the same active moiety, but different salt, ester or pharmaceutical form. Regulatory agencies have different criteria for this kind of drug. The European Medicines Agency (EMA) accepts the generic substitution using these alternatives, whereas the Food and Drug Administration (FDA) only authorizes generic substitution of pharmaceutical equivalents. The objective of this paper is to describe some relevant aspects that should be considered before deciding on making a generic substitution with pharmaceutical alternatives. It is important to note that a pharmaceutical alternative must show no significant difference in the rate and extent of absorption (bioequivalence) in a well-conducted in vivo study when compared with the reference formulation. Current Mexican regulations state that generic substitution is possible using pharmaceutical alternatives when bioequivalence is demonstrated in in vivo studies conducted under the NOM-177-SSA1-2013 criteria. In conclusion, generic substitution with pharmaceutical alternatives is possible if these products demonstrate in vivo bioequivalence when compared with the reference product.

scholarly journals The Use of Phospholipids to Make Pharmaceutical Form Line Extensions

2021 ◽  
pp. 2000297
Author(s):  
Peter Hoogevest ◽  
Harry Tiemessen ◽  
Josbert M. Metselaar ◽  
Simon Drescher ◽  
Alfred Fahr
Keyword(s):  
Line Extensions ◽  
Pharmaceutical Form

Copper Corrosion Issue Analysis and Study on Advanced CMP Process

2021 ◽  
Author(s):  
Lei Zhang ◽  
Yuanyuan Meng ◽  
Yi Xian ◽  
Wei Zhang ◽  
Haifeng Zhou ◽  
...  
Keyword(s):  
Copper Corrosion ◽  
Issue Analysis ◽  
Analysis And Study
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