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 …

Methodology of oral formulation selection in the pharmaceutical industry

M Kuentz, R Holm, DP Elder - European Journal of Pharmaceutical …, 2016 - Elsevier
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 …

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 …

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 …

Stability of pharmaceutical salts in solid oral dosage forms

H Nie, SR Byrn, Q Zhou - Drug Development and Industrial …, 2017 - Taylor & Francis
Using pharmaceutical salts in solid dosage forms can raise stability concerns, especially salt
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 …

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 …

[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 …

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 …

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 …