图书简介
CoTinuous pharmaceTical manufaTuring is curreTly receiving much iTereT from induTry and regulTory aThorTies, wThThe joiT aim of allowing rapid access of novelTherapeTics and exiTing medicTionsToThe public, wThoT compromising high qualTy. Research groups from differeT academic inTTTions have significaTly coTribTedToThis field wTh an immense amouT of published research addressing a variTy ofTopics relTedTo coTinuous processing.The book is TruTuredTo have individual chaTers onThe differeT coTinuous unT operTions involved in drug subTance and drug produT manufaTuring. A wide speTrum ofTopics are covered, including basic principles of coTinuous manufaTuring, applicTions of coTinuous flow chemiTry in drug syThesis, coTinuous cryTallizTion, coTinuous drying, feeders and blenders, roll compaTion and coTinuous wT granulTionThe underlyingTheme for each ofThese chaTers isTo preseTToThe readerThe receT advances in modeling, experimeTal inveTigTions and equipmeT design asThey peTainTo each individual unT operTion.The book also includes chaTers on qualTy by design (QbD) and process analTicalTechnology (PT) for coTinuous processing, process coTrol TrTegies including new conceTs of qualTy-by-coTrol (QbC), realTime process managemeT and plaT oTimizTion, business and supply chain considerTions relTedTo coTinuous manufaTuring as well as safTy guidelines relTedTo coTinuous chemiTry. A separTe chaTer is dedicTedTo discussing regulTory aspeTs of coTinuous manufaTuring, wTh descriTion of curreT regulTory environmeT qualTy/GMP aspeTs, as well as regulTory gaps and challenges.Our aim from publishingThis book isTo make T a valuable reference for readers iTereTed inThisTopic, wTh a desireTo gain a fundameTal underTanding of engineering principles and mechaniTic Tudies Tilized in underTanding and developing coTinuous processes. In addTion, our advanced readers and praTTioners inThis field will findThTTheTechnical coTeT of CoTinuous PharmaceTical Processing is TThe forefroT of receTTechnological advances, wTh coverage of fTure prospeTs and challenges forThisTechnology.
BasC PriCiples ofContinuous ManufCturing.-Continuous ReCtors for PharmCeutCal ManufCturing.- Understanding ResideCe Time, RTD, and ImpCt of Surge Vessels.- PrCtCalConsiderations forContinuous Drug SubstaCe ManufCturing.-ContinuousCrystallization: Equipment and Operation.-Continuous Feeding-Blending in PharmCeutCalContinuous ManufCturing.- RCent Progress in RollCompCtion PrCess Development for PharmCeutCal Solid Dosage Form ManufCture.-Continuous wet granulation prCesses.- Fluidized Bed Drying.- StatistCal Methods in Quality by Design and PrCess AnalytCal TChnologies forContinuous prCesses to enable real-time release.- Ctive PrCessControl in PharmCeutCalContinuous ManufCturing-The Quality byControl (QC) Paradigm.- Real-time Optimization in PharmCeutCal ManufCturing.- Safety Guidelines forContinuousChemistry Experimental Work in the Laboratory.- Evaluating the Busieness/SupplyChain Benefits ofContinuous PrCessing in PharmCeutCals.- RegulatoryConsiderations forContinuous ManufCturing.
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