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in..vitro..studies..followed..by..the..animal..testing..to..check..kinetics ,..toxicity..and..carcinogenicity..tests..are..performed...Solid..state..re actions..in..the..dosage..form..can..occur..when..the..drug..substance..is. .reactive..and..may..be..accelerated..by..physical..and..chemical..interact ion..with..excipients...For...example,...primary...and...secondary...amines ...can...react...with...lactose,...glucose...and...maltose...to...form...gl ycosylamines...(Serajuddin...et...al.,...1999andWirth...et...al.,...1998).. ..Related.book.content.No.articles.found..Citing..articles..(0)..This..arti cle..has..not..been..cited...For..more..information,..visit..the..cookies.. page.Copyright....2016..Elsevier..B.V...Article...suggestions...will...be.. .shown...in...a...dialog...on...return...to...ScienceDirect....Introduction Guided..by..pharmacology..and..clinical..sciences,..and..driven..by..chemis try,..pharmaceutical..research..in..the..past..has..played..a..crucial..rol e..in..the..progress..of..development..of..pharmaceuticals...For...this...a nalytical...instrumentation...and...methods...play...an...important...role. ...IMP:..investigational..medicinal..product..i.e...
However,..insufficient..in-process..control..may..result..in..the..products ..suffering..from..surface..irregularities..(Akseli..et..al.,..2008andVargh ese..and..Cetinkaya,..2007)...When...the...final...article...is...assigned. ..to...volumes/issues...of...the...Publication,...the...Article...in...Pres s...version...will...be...removed...and...the...final...version...will...ap pear...in...the...associated...published...volumes/issues...of...the...Publ ication....The.guideline.recommends.applicants.to.consider.other.enantiomer .as.an.impurity.and.to.set.the.identity.tests.capable.of.distinguishing.bot h.enantiomers.and.the.racemic.mixture..In...this...phase...the...potential. ..interaction...of...the...drug...with...other...medicines...is...determine d...and...monitors...drug’s...long...term...effectiveness....The..clinica l..trials..check..whether..the..drug..is..working..in..the..proposed..mecha nism..or..not,..its..optimum..dose..and..schedule..while..the..last..two..s tages..generate..statistically..important..data..about..efficacy,..safety.. and..overall..benefit–risk..association..of..the..drug...After.passing.th e.pre-clinical.tests.the.regulatory.authorities.grant.permission.for.the.cl inical.trials..This...page...uses...JavaScript...to...progressively...load. ..the...article...content...as...a...user...scrolls....In.addition,.the.fin ished.products.may.contain.unidentified.foreign.matter.particles..Please.no te.that.Internet.Explorer.version.8.x.will.not.be.supported.as.of.January.1 ,.2016..
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