LEADER 01110nam0-22003491i-450- 001 990000685790403321 005 20001010 010 $a0.262.12143.3 035 $a000068579 035 $aFED01000068579 035 $a(Aleph)000068579FED01 035 $a000068579 100 $a20001010d--------km-y0itay50------ba 101 0 $aita 105 $ay-------001yy 200 1 $aCity sense and city design$ewritings and projects of Kevin Lynch$fedited by Tridib Banerjee and Michael Southworth. 210 $aCambridge, Mass.$cMIT Press$d1990 215 $aIX, 853 p.$cill.$d25 cm 610 0 $aPianificazione urbana$aStoria$a20th century 610 0 $aPianificazione urbana$aStati Uniti$aStoria$a20th century 610 0 $aLynch, Kevin$a1918$aFilosofia 700 1$aLynch,$bKevin$f<1918-1984>$011116 702 1$aBanerjee,$bTridib 702 1$aSouthworth,$bMichael 801 0$aIT$bUNINA$gRICA$2UNIMARC 901 $aBK 912 $a990000685790403321 952 $a01 B2 II 32.B$b01962$fDINST 959 $aDINST 996 $aCity sense and city design$9325680 997 $aUNINA DB $aING01 LEADER 01222nam a2200301 i 4500 001 991003965859707536 005 20020509151507.0 008 991108s1996 ne ||| | eng 020 $a9050631274 035 $ab11241482-39ule_inst 035 $aPARLA192281$9ExL 040 $aDip. di Filol. Class. e di Scienze Filosofiche$bita 041 0 $aeng$agrc 082 0 $a090.0880 100 1 $aRoemer, Cornelia E.$0540961 245 10$aP. Michigan Koenen :$b(= P. Mich. XVIII) :$bMichigan texts published in honor of Ludwig Koenen /$cedited by Cornelia E. Römer & Traianos Gagos ; consulting editors Ann E. Hanson & Pieter J. Sijpesteijn 260 $aAmsterdam :$bGieben,$c1996 300 $aXXXIV, 416 p., [21] p. di tav. ;$c29 cm. 490 0 $aStudia Amstelodamensia ad epigraphicam ;$v36 650 4$aPapiri documentari - Greci 650 4$aPapiri letterari - Greci 700 1 $aGagos, Traianos 907 $a.b11241482$b23-02-17$c01-07-02 912 $a991003965859707536 945 $aLE007 P A 1645/18$g1$i2007000048672$lle007$o-$pE0.00$q-$rn$so $t0$u0$v0$w0$x0$y.i11399909$z01-07-02 996 $aP. Michigan Koenen$9868874 997 $aUNISALENTO 998 $ale007$b01-07-02$cm$da $e-$feng$gne $h0$i1 LEADER 03715nam 22005295 450 001 9910298400003321 005 20200702104417.0 010 $a3-030-02472-5 024 7 $a10.1007/978-3-030-02472-7 035 $a(CKB)4100000007142768 035 $a(MiAaPQ)EBC5598976 035 $a(DE-He213)978-3-030-02472-7 035 $z(PPN)258872322 035 $a(PPN)232472823 035 $a(EXLCZ)994100000007142768 100 $a20181116d2018 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aSolid Oral Dose Process Validation $eThe Basics, Volume 1 /$fby Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Emilija Fredro-Kumbaradzi, Jordan Collins 205 $a1st ed. 2018. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2018. 215 $a1 online resource (99 pages) 225 1 $aAAPS Introductions in the Pharmaceutical Sciences,$x2522-834X 311 $a3-030-02471-7 327 $aVolume One.Preface -- Lifestyle Approach to Validation -- Solid Dose Formulations -- Stage 1A Process Design: Quality by Design -- Knowledge Management and Risk Assessment for Lifestyle Stages -- .Stage 1B Process and Scale Up Considerations -- Stage 2A and 2B Process Qualifications -- Stage 3A and 3B: Continued Process Verification. 330 $aCurrently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance?s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. 410 0$aAAPS Introductions in the Pharmaceutical Sciences,$x2522-834X 606 $aPharmaceutical technology 606 $aPharmacy 606 $aPharmaceutical Sciences/Technology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21010 606 $aPharmacy$3https://scigraph.springernature.com/ontologies/product-market-codes/F00008 615 0$aPharmaceutical technology. 615 0$aPharmacy. 615 14$aPharmaceutical Sciences/Technology. 615 24$aPharmacy. 676 $a615.19 700 $aPazhayattil$b Ajay Babu$4aut$4http://id.loc.gov/vocabulary/relators/aut$01057742 702 $aSayeed-Desta$b Naheed$4aut$4http://id.loc.gov/vocabulary/relators/aut 702 $aFredro-Kumbaradzi$b Emilija$4aut$4http://id.loc.gov/vocabulary/relators/aut 702 $aCollins$b Jordan$4aut$4http://id.loc.gov/vocabulary/relators/aut 906 $aBOOK 912 $a9910298400003321 996 $aSolid Oral Dose Process Validation$92494377 997 $aUNINA