a simple, sensitive, accurate and precise simultaneous uv spectrophotometric method has been developed for the estimation of carisoprodol, paracetamol and caffeine in tablet dosage form. the absorption maxima of the drugs were found to be 221, 248 and 273 nm for carisoprodol, paracetamol and caffeine respectively, in methanol, using a double beam uv/visible spectrophotometer. carisoprodol, para...

The origins of safety pharmacology are grounded upon observations that organ functions (like organ structures) can be toxicological targets in humans exposed to novel therapeutic agents, and that drug effects on organ functions (unlike organ structures) are not readily detected by standard toxicological testing. Safety pharmacology is " em leader those studies that investigate the potential und...

Evaluating whether a new medication prolongs QT intervals is a critical safety activity that is conducted in a sensitive animal model during non-clinical drug development. The importance of QT liability detection has been reinforced by non-clinical [International Conference on Harmonization (ICH) S7B] and clinical (ICH E14) regulatory guidance from the International Conference on Harmonization....

Current testing for proarrhythmic potential of drugs relies on determining their effect on the QT interval of the ECG. Because QT prolongation is frequently associated with blockade of the human ether-à-go-go related gene (hERG) channel, the International Conference on Harmonization (ICH) S7B guideline recommends an hERG inhibition assay as the first proxy for identifying such potential risk. S...

A simple, sensitive, specific, spectrophotometric method was developed for the detection of Olmesartan medoxomil (OLM) in bulk and pharmaceutical formulations. The optimum conditions for the analysis of the drug were established. OLM was subjected to stress degradation under different conditions recommended by the International Conference on Harmonization (ICH). The samples so generated were us...

Genotoxicity is the most commonly used endpoint to predict the carcinogenicity of chemicals. The International Conference on Harmonization (ICH) M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk offers guidance on (quantitative) structure-activity relationship ((Q)SAR) methodologies that predict the outcome of b...

A simple and inexpensive titrimetric method for the determination of magnesium ion in esomeprazole magnesium raw material was developed and validated according to International Conference on Harmonization guidelines and the United States Pharmacopoeia. The method depends on complex formation between EDTA and magnesium ion. The method was proven to be valid, equivalent and useful as an alternati...

The current practice of characterization and control of impurities in pharmaceutical substances and products are reviewed with emphasis on issues specific to the active pharmaceutical ingredient and pharmaceutical formulations. The control of pharmaceutical impurities in the pharmaceutical industry is an important task to the formulator. The International Conference on Harmonization (ICH) has f...

Editorial I welcome all to the current issue of Pharmaceutical Methods, and thank all our contributors. The reader will find that many of the articles that are published in the current issue refer to method validation and in particular to the International Conference on Harmonization (ICH) guidelines as the basis for their approach. The ICH was launched in 1990, with the objective of harmonizin...