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Designing a robust cleaning process for pharmaceutical drug manufacturing is critical to successful cleaning validation and verification.
The purpose of process development in pharma is to select and optimise a synthetic route to produce the active pharmaceutical ingredient (API) by the safest, cheapest, fastest, and cleanest (by green chemistry where possible) route, following both Good Laboratory Practice (GLP) and Quality by Design (QbD) principles.
HPLC is a rapid, accurate and sensitive method for determination of pharmaceutical drugs, degradations and impurity profiling. It is a preferred method for analytical characterisation during drug development.
CPhI & P-MEC India opens as report ranks India the world’s fastest improving pharma market and first for ‘growth potential’ for 2019...
Reference standards play a critical role in pharmaceutical drug development from preclinical to commercial analytical support.
Companies often need to arrange for the synthesis of test substances to support research and development efforts.
BioSpectra offers US based, custom GMP manufacturing of small molecules...
A trial has shown that radiotherapy is more effective when levels of ropidoxuridine in a patients' body reach a certain level...
For several decades mass spectrometry (MS) has been used in the characterisation of protein pharmaceuticals.1-3 However, its use in the laboratory for quality control (QC) product release testing has been quite limited for a number of reasons, for example: instrument complexity and software are not readily amenable to validation, extensive…
In this issue: investment in biopharmaceuticals, particle size methods, and unlocking the potential of new technologies like Lab-on-a-chip.
The pharmacovigilance of new drugs and drug formulations undertaken in New Zealand should be proactive, says a leading expert.
The EU and Japan have agreed to widen the range of medicines for which they will recognise each other’s inspections of manufacturing sites.
The FDA has approved Epidiolex oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy...
Researchers have created a device that can quickly and inexpensively determine whether new pharmaceutical formulations have trace crystallinity...
Two common iron compounds increase the formation of a known biomarker for cancer...
