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Sie suchen in allen Bereichen nach dem Autor Wolkerstorfer A.
In der Rubrik Zeitschriften haben wir 2 Beiträge für Sie gefunden
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MerkenScientific and regulatory aspects of solid phase reactions in forced degradation studies
Rubrik: europharm
(Treffer aus pharmind, Nr. 12, Seite 1731 (2015))
Wolkerstorfer A | Buschmann H | Handler N
Scientific and regulatory aspects of solid phase reactions in forced degradation studies / Part 2 * Part 1 see Pharm. Ind. 2015;77(10): 1484–1491. : Solid phase reactions as new challenge in forced degradation studies · Wolkerstorfer A, Buschmann H, Handler N · RD&C Research, Development & Consulting, Vienna (Austria)
Forced degradation studies – also referred to as stress testing – are processes that involve degradation of drug product (DP) and drug substance (DS) at conditions more severe than at accelerated conditions and thus generate degradation products that can be studied to determine the stability of a molecule [ 1 ]. These investigations that involve exposure of DS, DP, unpackaged products and/or packaged products containing them, to specified harsher conditions of catalytic external and internal stressors of defined strength, such as heat, moisture, pH, oxidants, metal species, and light. These studies are an essential part in the design of a regulatory ...
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MerkenScientific and regulatory aspects of solid phase reactions in forced degradation studies
Rubrik: europharm
(Treffer aus pharmind, Nr. 10, Seite 1484 (2015))
Wolkerstorfer A | Buschmann H | Handler N
Scientific and regulatory aspects of solid phase reactions in forced degradation studies / Part 1: A practical approach and regulatory considerations of forced degradation studies · Wolkerstorfer A, Buschmann H, Handler N · RD&C Research, Development & Consulting, Vienna (Austria)
The chemical stability of pharmaceutical molecules is a matter of great concern as it affects safety and efficacy of drug products (DP) on the one hand, and involves considerable cost, time consumption and competitiveness on the other. Stability testing evaluates the effect of intrinsic drug properties and environmental factors on the quality of a drug substance (DS) or a formulated DP. It is and is then utilized to predict the shelf life, to determine proper storage conditions and to suggest labeling instructions. Meaningful product expiration dates are obtained after thorough, scientifically designed studies using specific stability indicating assays and appropriate, ...
