Friebe T.P.,Care GmbH |
Gray A.,Care GmbH |
Asgarzadeh F.,Evonik Industries |
Hughes K.,Colorcon Ltd |
And 4 more authors.
Pharmaceutical Technology Europe | Year: 2015
ADD of MR dosage forms poses a possible risk to a subsegment of the patient population. Regulatory agencies have, therefore, introduced guidance for formulators to mitigate the risk of a potentially concerned formulation with regard to ADD. However, the necessity of testing in simplified in-vitro systems that may not represent probable physiological conditions may create technological hurdles to developing efficacious dosage forms at reasonable costs to patients. The current lack of alignment of requirements between regions increases complexity, and hence, increases cost of medicines for globally active companies. Given the increasing globalization of the pharmaceutical industry, the FDA and EMA guidelines should be harmonized concerning ADD in-vitro testing conditions, reflecting physiologically relevant alcohol concentrations and exposure times. Source
Gattefosse Sas and Gattefosse S.A. | Date: 1996-10-15
Gattefosse Sas | Date: 2015-10-07
Chemical products for use in the composition of cosmetic, pharmaceutical, veterinary, food, dietetic products and food supplements; plant extracts, active principles and excipients for use in the composition of cosmetic, pharmaceutical, veterinary, food, dietetic products and food supplements.
Gattefosse Sas, Gattefosse S.A. and Gattefosse | Date: 1996-09-17
Gattefosse Sas | Date: 2005-12-13
Chemical preparations, namely, textures, bases, ingredients and emulsifiers for the manufacture of cosmetic products.