%PDF-1.3 1 0 obj << /Type /Catalog /Outlines 2 0 R /Pages 3 0 R >> endobj 2 0 obj << /Type /Outlines /Count 0 >> endobj 3 0 obj << /Type /Pages /Kids [6 0 R 23 0 R 25 0 R ] /Count 3 /Resources << /ProcSet 4 0 R /Font << /F1 8 0 R /F2 9 0 R /F3 10 0 R /F4 11 0 R >> /XObject << /I1 12 0 R /I2 13 0 R /I3 18 0 R >> >> /MediaBox [0.000 0.000 595.280 841.890] >> endobj 4 0 obj [/PDF /Text /ImageC ] endobj 5 0 obj << /Creator (DOMPDF) /CreationDate (D:20220609122028-04'00') /ModDate (D:20220609122028-04'00') /Title (Principles of Parenteral Solution Validation: A Book Review) >> endobj 6 0 obj << /Type /Page /Parent 3 0 R /Annots [ 14 0 R 16 0 R 19 0 R 21 0 R ] /Contents 7 0 R >> endobj 7 0 obj << /Length 5176 >> stream 1.000 1.000 1.000 rg 34.016 34.016 527.249 773.859 re f q 441.000 0 0 97.500 45.016 710.374 cm /I2 Do Q 0.000 0.000 0.000 rg BT 45.016 699.385 Td /F1 9.0 Tf [(Published on )] TJ ET BT 99.547 699.385 Td /F2 9.0 Tf [(IVT Network)] TJ ET BT 149.056 699.385 Td /F1 9.0 Tf [( \()] TJ ET BT 154.555 699.385 Td /F1 9.0 Tf [(http://www.ivtnetwork.com)] TJ ET 0.000 0.000 0.000 RG 0.18 w 0 J [ ] 0 d 154.555 698.234 m 259.081 698.234 l S BT 259.081 699.385 Td /F1 9.0 Tf [(\))] TJ ET 0.620 0.620 0.620 rg 45.016 686.888 506.159 0.750 re f 0.000 0.000 0.000 rg BT 45.016 662.142 Td /F3 15.0 Tf [(Principles of Parenteral Solution Validation: A Book Review)] TJ ET q 45.016 586.047 506.159 57.986 re W n 0.800 0.800 0.800 rg 45.016 643.658 13.005 0.750 re f 0.000 0.000 0.000 rg BT 45.016 610.919 Td /F1 9.0 Tf [(By)] TJ ET 0.800 0.800 0.800 rg 58.021 643.658 59.022 0.750 re f q 31.500 0 0 25.500 61.771 618.533 cm /I3 Do Q 0.000 0.000 0.000 rg BT 117.043 633.044 Td /F4 9.0 Tf [(Paul L. Pluta)] TJ ET 0.800 0.800 0.800 rg 117.043 643.658 110.052 0.750 re f 0.000 0.000 0.000 rg BT 117.043 612.794 Td /F4 9.0 Tf [(Mar 24, 2021 7:00 am EDT)] TJ ET Q BT 45.016 555.160 Td /F4 10.5 Tf [(INTRODUCTION)] TJ ET BT 45.016 530.427 Td /F1 9.0 Tf [(This review describes the recently-published Principles of Parenteral Solution Validation, A Practical Lifecycle Approach, )] TJ ET BT 45.016 516.690 Td /F1 9.0 Tf [(edited by Igor Gorsky and Harold S. Baseman. This book is part of the Expertise in Pharmaceutical Process Technology )] TJ ET BT 45.016 502.954 Td /F1 9.0 Tf [(series published by Academic Press \(Elsevier\) and edited by Michael Levin. Igor Gorsky is a member of the Editorial Advisory )] TJ ET BT 45.016 489.218 Td /F1 9.0 Tf [(Board of the IVT Network.)] TJ ET BT 45.016 464.952 Td /F1 9.0 Tf [(This review describes the book purpose, target audience, and technical content. Specific book characteristics are highlighted.)] TJ ET BT 45.016 440.685 Td /F1 9.0 Tf [(This book provides an excellent and comprehensive review of a complex subject. Content in this book will be useful to all )] TJ ET BT 45.016 426.949 Td /F1 9.0 Tf [(involved in sterile product manufacturing and validation. This book would be a valuable addition to the personal library of )] TJ ET BT 45.016 413.213 Td /F1 9.0 Tf [(pharma product practitioners and a valuable reference in the workplace environment.)] TJ ET BT 45.016 387.507 Td /F4 9.0 Tf [(Book Purpose)] TJ ET BT 45.016 361.800 Td /F1 9.0 Tf [(The stated goal of this book is to provide parenteral drug manufacturers with a volume that helps with their implementation of )] TJ ET BT 45.016 348.064 Td /F1 9.0 Tf [(comprehensive process validation programs as well as to becoming a go-to reference on this important subject.)] TJ ET BT 45.016 322.358 Td /F4 9.0 Tf [(Target Audience)] TJ ET BT 45.016 296.652 Td /F1 9.0 Tf [(The primary audience for the Expertise in Pharmaceutical Process Technol series comprises pharmaceutical personnel from )] TJ ET BT 45.016 282.915 Td /F1 9.0 Tf [(low-level R&D and production technicians to team leaders and department heads an extensive range of readers from doers )] TJ ET BT 45.016 269.179 Td /F1 9.0 Tf [(to management. In addition to these various activity levels, industry practitioners in sterile product validation include a wide )] TJ ET BT 45.016 255.443 Td /F1 9.0 Tf [(range of disciplines including engineers, microbiologists, pharmacists, chemists, and other technical fields. The authors also )] TJ ET BT 45.016 241.707 Td /F1 9.0 Tf [(surveyed industry experts when designing book content and addressed recommended subjects. These recommendations, )] TJ ET BT 45.016 227.970 Td /F1 9.0 Tf [(e.g., FDA guidance applications, risk management, experimental study design, scale-up and technology transfer, and case )] TJ ET BT 45.016 214.234 Td /F1 9.0 Tf [(studies demonstrate the range of topics addressed in this book.)] TJ ET BT 45.016 188.528 Td /F4 9.0 Tf [(Book Type)] TJ ET BT 45.016 162.822 Td /F1 9.0 Tf [(Technical books may be categorized into various general types, e.g., user manuals, teaching books, reference books, )] TJ ET BT 45.016 149.085 Td /F1 9.0 Tf [(procedures, questions, and answers \(FAQ\), general discussions, and several others. Principles of Parenteral Solution )] TJ ET BT 45.016 135.349 Td /F1 9.0 Tf [(Validation Technology addresses part or all of these categories in its various chapters. Although the book subtitle explicitly )] TJ ET BT 45.016 121.613 Td /F1 9.0 Tf [(states A Practical Lifecycle Approach and the stated emphasis of the Expertise in Pharmaceutical Process Technology series )] TJ ET BT 45.016 107.877 Td /F1 9.0 Tf [(is to be a practical guide for practitioners, this book provides much more that practical content. Validation of parenteral solution )] TJ ET BT 45.016 94.140 Td /F1 9.0 Tf [(products is a complex subject. Practitioners described above represent a variety of technical disciplines. The content of this )] TJ ET BT 45.016 80.404 Td /F1 9.0 Tf [(book provides useful information to all who are involved in parenteral product validation and supporting functions.)] TJ ET endstream endobj 8 0 obj << /Type /Font /Subtype /Type1 /Name /F1 /BaseFont /Helvetica /Encoding /WinAnsiEncoding >> endobj 9 0 obj << /Type /Font /Subtype /Type1 /Name /F2 /BaseFont /Helvetica-Oblique /Encoding /WinAnsiEncoding >> endobj 10 0 obj << /Type /Font /Subtype /Type1 /Name /F3 /BaseFont /Times-Roman /Encoding /WinAnsiEncoding >> endobj 11 0 obj << /Type /Font /Subtype /Type1 /Name /F4 /BaseFont /Helvetica-Bold /Encoding /WinAnsiEncoding >> endobj 12 0 obj << /Type /XObject /Subtype /Image /Width 588 /Height 130 /Filter /FlateDecode /DecodeParms << /Predictor 15 /Colors 1 /Columns 588 /BitsPerComponent 8>> /ColorSpace /DeviceGray /BitsPerComponent 8 /Length 8715>> stream x]OK#MDA+x !\K ބ {o/|ygz&Y}Nt]]]UyD~|VVd`蓨CFAgy~u2W!Bm}u%2gSFDK_]惂la蓨-L}U)ϢKݯDFsA0_]恊W"+ Sk<`k
KGF>-2ݓ>NgL$S]-LIF&ۯGF>ֿ"TQX?)_V+֧Rptx{=Qt=އA{ YQnjk:0`vG>ǁɦ[vMB@|^j#Ң-UAw:w*T'=Nh<
F3AIHc[e`vɏċ>/BhQEf.b4@FS!%ʕ )dg靟MQ +[`:@;y=JtL+A"=nz5-"x0mw~ܼrbIۥ@Z~GvK/¨ӰJˉmE Tߞx#
ZUxi9mn=䰟aS:*$,Lu{ͯT=j3aQv{"
ns&oZ>q3x,9h+ `$ D?s:FDSVMU̠hqJRߤ0k5"Adzz37fitvN:ݥd0$ls`҂
Q0VI8݈)ID3TL;d*7`ڹ= 6"
:u9