Development of validated stability-indicating assay methods—critical review
M Bakshi, S Singh - Journal of pharmaceutical and biomedical analysis, 2002 - Elsevier
This write-up provides a review on the development of validated stability-indicating assay
methods (SIAMs) for drug substances and products. The shortcomings of reported methods …
methods (SIAMs) for drug substances and products. The shortcomings of reported methods …
Methodology of oral formulation selection in the pharmaceutical industry
Pharmaceutical formulations have to fulfil various requirements with respect to their intended
use, either in the development phase or as a commercial product. New drug candidates with …
use, either in the development phase or as a commercial product. New drug candidates with …
Advances in simultaneous DSC–FTIR microspectroscopy for rapid solid-state chemical stability studies: some dipeptide drugs as examples
SY Lin, SL Wang - Advanced drug delivery reviews, 2012 - Elsevier
The solid-state chemistry of drugs has seen growing importance in the pharmaceutical
industry for the development of useful API (active pharmaceutical ingredients) of drugs and …
industry for the development of useful API (active pharmaceutical ingredients) of drugs and …
Stability of aspartame in the soft drinks: Identification of the novel phototransformation products and their toxicity evaluation
J Trawiński, R Skibiński - Food Research International, 2023 - Elsevier
Photolytic transformation of aspartame–a widely used artificial sweetener–under the
simulated sunlight was studied for the first time. The experiments were conducted in pH …
simulated sunlight was studied for the first time. The experiments were conducted in pH …
Stability of pharmaceutical salts in solid oral dosage forms
Using pharmaceutical salts in solid dosage forms can raise stability concerns, especially salt
dissociation which can adversely affect the product performance. Therefore, a thorough …
dissociation which can adversely affect the product performance. Therefore, a thorough …
Biowaiver monographs for immediate-release solid oral dosage forms: Enalapril
RK Verbeeck, I Kanfer, R Löbenberg… - Journal of …, 2017 - Elsevier
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence testing for
the marketing authorization of immediate-release, solid oral dosage forms containing …
the marketing authorization of immediate-release, solid oral dosage forms containing …
Study of forced degradation behavior of enalapril maleate by LC and LC–MS and development of a validated stability-indicating assay method
SP Bhardwaj, S Singh - Journal of pharmaceutical and biomedical analysis, 2008 - Elsevier
In the present study, comprehensive stress testing of enalapril maleate was carried out
according to ICH guideline Q1A (R2). The drug was subjected to acid (0.1 N HCl), neutral …
according to ICH guideline Q1A (R2). The drug was subjected to acid (0.1 N HCl), neutral …
[图书][B] The process of new drug discovery and development
GS Charles - 1992 - books.google.com
The Process of New Drug Discovery and Development presents a practical methodology for
maximizing the ability of a multidisciplinary research team to discover and bring new drugs …
maximizing the ability of a multidisciplinary research team to discover and bring new drugs …
Perindopril arginine: benefits of a new salt of the ACE inhibitor perindopril
E Telejko - Current medical research and opinion, 2007 - Taylor & Francis
Background: The efficacy of the angiotensin-converting enzyme (ACE) inhibitor perindopril
in the treatment of hypertension, stable coronary artery disease, and heart failure is well …
in the treatment of hypertension, stable coronary artery disease, and heart failure is well …
Effects of automated external lubrication on tablet properties and the stability of eprazinone hydrochloride
T Yamamura, T Ohta, T Taira, Y Ogawa, Y Sakai… - International journal of …, 2009 - Elsevier
We investigated the advantages of an external lubrication technique for tableting. A newly
developed external lubricating system was applied to tableting in a rotary tablet press using …
developed external lubricating system was applied to tableting in a rotary tablet press using …