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ICH Q14 – latest guideline on analytical procedure development

This article covers the ICH Q14 on analytical procedure development, discussing its impact during commercial phases and clinical development.

United kingdomDave elderAnalysis groupAnalytical division councilCommittee for medicinal products humanBritish pharmacopoeia expert advisory groupDivision councilJoint pharmaceutical analysis groupVersion adoptedAnalytical proceduresMedicinal productsFluid chromatographyChiral analysisAnalytical target profile

Amira Guirguis: We want to use our expertise to prepare for future threats

The Pharmaceutical Journal from the Royal Pharmaceutical Society

United kingdomAmira guirguisUniversity of swanseaCardiff universityHealth educationCouncil gphSwansea university medical schoolRoyal pharmaceutical societyAnalysis groupUniversity of hertfordshireJoint pharmaceutical analysis groupGeoffrey phillips awardPharmaceutical journalGeneral pharmaceutical councilImprovement walesSouth wales

Nitrosamines: the beginning of the end?

Nitrosamines: the beginning of the end?
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United kingdomDave elderAnalysis groupBritish pharmacopoeia expert advisory groupEuropean federation of pharmaceutical industriesRisk factors for nitrosamine impurities in pharmaceuticalsAnalytical division councilNitrosamines international technical working groupEuropean medicines agencyEuropean federationPharmaceutical industriesEuropean pharmacopeiaDivision councilJoint pharmaceutical analysis groupRegul toxicolOrg process res

Quality requirements for tobacco - tobacco-specific nitrosamines

Here, Dave Elder explores proposals for new FDA rules on tobacco product manufacturing and the concerns around tobacco-specific nitrosamines.

United kingdomEl karnbaneDave elderAlami chentoufiBritish pharmacopoeia expert advisory groupAnalytical division councilDrug administrationCommittee for medicinal products human useAnalysis groupAnnouncements on nitrosamine in varenicline chantixTobacco products directiveEuropean pharmacopoeiaDivision councilJoint pharmaceutical analysis groupDrug useYoung people

NITROSAMINES: Where now?

Here, Dave Elder reflects on the three main instances of nitrosamine contamination as impurities in drug products.

United kingdomDave elderKenyonm kalgutkarStakeholder forumNonclinical evaluation for anticancer pharmaceuticalsBritish pharmacopoeia expert advisory groupAnalysis groupDrug administrationAnalytical division councilChemspider referenceLhasa cancer potency databaseDivision councilJoint pharmaceutical analysis groupRoot causeRanitidine hydrochloride drug substancesAssociated drug