ICH guideline
Development of stability indicating RP HPLC method for the estimation of Fingolimod in its bulk dosages form as per ICH guideline
... (ICH) guideline entitled stability testing of new drug substances and products requires that stress testing be carried out to elucidate the inherent stability characteristics of the active ...
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ICH guideline practice: application of validated RP-HPLC-DAD method for determination of tapentadol hydrochloride in dosage form
... Thus, there is still a gap in research work; there is no method for the determination of TAP in dosage form, which claims that there is no interference of any excipi- ents in determination without using complex mobile ...
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ICH guideline practice: application of novel RP-HPLC-DAD method for determination of olopatadine hydrochloride in pharmaceutical products
... According to the International Conference on Harmonisa- tion of Technical Requirements for Registration of Pharma- ceutical for Human Use (ICH) guidelines (ICH 2000a, b), the developed method was validated ...
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US and EU radiopharmaceutical diagnostic and therapeutic nonclinical study requirements for clinical trials authorizations and marketing authorizations
... far ICH(M3) guideline (ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals, ...draft Guideline, ...
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Validated Spectrophotometric method for estimation of Paclitaxel in Bulk and Pharmaceutical Formulation
... The precision studies for the proposed method was carried out as per ICH guideline at the given wavelength (230nm).The intraday and interday precisions of the proposed methods were determined by estimating ...
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Development of antiproliferative long-circulating liposomes co-encapsulating doxorubicin and curcumin, through the use of a quality-by-design approach
... in the ICH guideline Q8(R2), a QbD study includes the fol- lowing elements of the pharmaceutical development: 1) defin- ing the quality target product profile (QTPP), 2) identifying the[r] ...
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METHOD DEVELOPMENT AND STABILITY STUDY BY CHROMATOGRAPHIC METHOD FOR PERAMPANEL IN API AND TABLET DOSAGE FORM
... Forced Degradation Study of Perampanel in API and Tablet dosage form was carried out under dif- ferent stress conditions as mentioned in ICH guideline Q1A (R2).The standard solution contain- ing 100 μg/ml ...
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DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF NIMODIPINE CONTENT BY UVSPECTROSCOPIC METHOD
... The current research work deals with the development of UV Spectrophotometric method and its validation as per International Conference on Harmonization (ICH) guideline. [18-20] The developed method was ...
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Development and validation of stability-indicating HPLC method for simultaneous estimation of cefixime and linezolid
... The International Conference on Harmonization (ICH) guideline entitled “Stability testing of new drug substances and products” requires that stress testing be carried out to elucidate[r] ...
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ROLE OF ICH IN HARMONIZING DRUG REGULATION
... harmonisation. ICH is a unique undertaking that brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan and the United ...States. ICH guideline gives special ...
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Guideline-based quality indicators—a systematic comparison of German and international clinical practice guidelines
... the guideline databases of G-I-N (Guidelines International Network) and NGC (National Guideline Clearinghouse) between February and June 2017 to identify international CPGs matching the topics of German ...
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Systemaufstellungen in der Landwirtschaft – Drei Fallbeispiele mit Fokus auf Hof und Familie
... gehe ich angemessen mit dem Hof um? Ich habe das Gefühl, dass ich den Hof überall hin ...mitnehme. Ich gehe ständig über meine Grenzen, habe kein „Stop“ und oft das Gefühl, dass „ich es ...
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Koppehele, Eva (2008): Sterbehilfe - Sterbebegleitung alternativenlos, alternativ oder ganz anders?: Soziologische Studie zum Diskurs. Dissertation, LMU München: Sozialwissenschaftliche Fakultät
... Denk‘ ich oft noch an sie, ...bin ich auch zu christlich erzogen, ich denk’ einfach, das Leben is’ mir geschenkt, ...wenn ich mal tot bin, und die bei der Hilde eine essen oder so, dann is‘ ...
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Zoreva, Lioubov (2009): Die Eisenbahn im russischen kulturellen Raum. Dissertation, LMU München: Fakultät für Sprach- und Literaturwissenschaften
... Die Zugreise wird zum harmlosen Kontakt mit der Heimat und ihrer Natur (die Landschaften im Überfluss werden zur zwanghaften Komponente jeder Eisenbahnreise) und zum Anlass ihrer Mythologisierung – es entsteht ein ...
319
Canadian Urological Association guideline: Diagnosis, management, and surveillance of neurogenic lower urinary tract dysfunction Full text
... CUAJ ? CUA Guideline Kavanagh et al Guideline Neurogenic bladder Canadian Urological Association guideline for the diagnosis, management, and surveillance of neurogenic lower urinary tract dysfunction[.] ...
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Tiefenanalyse der realisierten Nachfrage nach Öko Lebensmitteln auf der Basis von Paneldaten
... Ich hätte gerne mehr Informationen über Bio- / Ökoprodukte Am wohlsten fühle ich mich zuhause Bei der Ernährung vermeide ich alles, was der Gesundheit schadet Bei Lebensmitteln bevorzuge[r] ...
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Canadian Urological Association guideline on perioperative thromboprophylaxis and management of anticoagulation
... Proper evaluation of the risks and benefits of thromboprophylaxis for urological surgery requires both procedure and patient specific knowledge 2-4 . To judge the net benefit of VTE prophylaxis one must know the ...
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Spontaneous Intracerebral Haemorrhage: Clinical Profile and Predictors of Outcome
... Ruiz Sandovol et al found that different cutoffs values for the variables in the scoring improved substantially the prognostic power of the predictors included in the ICH score, and designed the Intra Cerebral ...
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Recurrent brain hemorrhage is more frequent than ischemic stroke after intracranial hemorrhage
... recurrent ICH is not rare and occurs at twice the rate of ischemic stroke in survivors of primary ICH ...recurrent ICH and the relatively low rate of subsequent ischemic stroke suggest that vascular ...
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Denke, Eva-Maria (2011): Stellvertretende Entscheidungen für Demenzkranke: mutmaßlicher Wille und andere determinierende Faktoren. Dissertation, LMU München: Medizinische Fakultät
... also ich hab / mein Mann hatte einen Schlaganfall, mein Mann hat Darmkrebs gehabt, das alles in ganz dichten ...sagt. Ich war schon in Bad Aibling, in Ding und hab mich informiert, es war so, ein Rückfall, ...
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