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"Compatibility of pharmaceutical products and contact materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results.Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe :- Pertinent regulations and practical ways to meet guidelines- Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development- Materials characterization and the materials screening process- Component and/or system qualification (illustrated by several case studies)- Performing validation/migration studies and interpreting and reporting the results- Creating a product registration dossier and putting it through regulatory review- Product maintenance (Change Control) from an extractables and leachables perspective- Likely future developments in extractables and leachables assessmentAdditionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature."

"LATAR BELAKANG : Sirosis hati merupakan salah satu masalah kesehatan di Indonesia. Penyakit ini merupakan penyakit hati yang sering dijumpai selain hepatitis virus akut dan kanker hati. Komplikasi sirosis hati yang tersering adalah asites. Adanya asites merupakan prognosis yang buruk karena hanya sekitar 50% penderita sirosis hati dengan asites dapat bertahan hidup dalarn waktu 2 tahun. Asites juga merupakan faktor predisposisi terjadinya komplikasi berbahaya seperti Peritonitis Bakteri Spontan (PBS).BAHAN DAN METODE : 74 subyek penelitian penderita sirosis hati dengan asites. Pada cairan asites dilakukan biakan aerob-anaerob, pemeriksaan hitung leukosit dengan alat hitung sel otomatis Sysmex XT2000i®, hitung jenis leukosit dengan mikroskop dan uji leukosit esterase carik celup urin sedangkan pemeriksaan albumin, protein dan LDH dilakukan untuk serum dan cairan asites.HASIL : Pada penelitian ini didapatkan penderita PBS sebanyak 14 orang (18.92%). Pada kelompok PBS didapatkan netrositik asites sebanyak 12 orang (85.71%). Dari hasil biakan yang positif pads kelompok penderita PBS berhasil diisolasi dua jenis kuman golongan Enterobacteriaceae yaitu Escherichia call dan Enterobacter aerogenes. Kedua kuman ini diduga menghasilkan Extended Spectrum Beta Lactamase (ESBL). Dengan menggunakan cara perhitungan stastistik menurut Bland-Altman didapatkan bahwa hasil hitung jumlah leukosit pada cairan asites dengan menggunakan alat otomatis Sysmex XT2000P tidak berbeda bermakna dengan cara manual. Untuk memperkirakan jumlah PMN cairan asites ? 250 sellpL maka cut off point untuk MuitistixlOSG® adaiah pada skala trace sedangkan untuk Comburl4M® adalah pada skala positif-2. Sebagian besar cairan asites pada penderita PBS termasuk transudat berdasarkan kriteria Light (85.71 %). Pada 92.86 % penderita PBS mempunyai SAAG > 1.1 g/dL.KESIMPULAN : Pada penelitian ini diperoleh proporsi PBS sebesar 18.92 % dan proporsi netrositik asites sebesar 85.71%. Kedua jenis kuman batang Gram negatif diduga menghasilkan ESBL sehingga resisten terhadap Sefotaksim. Hitung leukosit cairan asites dapat dilakukan dengan alat penghitung sel otomatis Sysmex XT2000i. Leukosit esterase carik celup urin Multistixi OSG® dan Comburl0M@ dapat digunakan untuk memperkirakan jumlah PMN cairan asites > 250 sellpL. Cairan asites pada penderita PBS temasuk transudat menurut modifikasi kriteria Light. PBS tidak mempengaruhi SAAG.SARAN : Parasentesis diagnostik harus dilakukan sebelum pemberian antibiotik empirik. Leukosit esterase carik celup urin dapat digunakan sebagai salah satu cara untuk memdiagnosis PBS secara "bedside". Penelitian lanjutan untuk mendapatkan pola dan kepekaan antibiotika kuman penyebab PBS.

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Cirrhosis is identified as one of major health problems in Indonesia. It is found to be the most prevalent liver disease in addition to acute viral hepatitis and liver cancer. Ascites is the most common complication associated with cirrhosis. About 50% of patients with cirrhosis who develop ascites die within 2 years of diagnosis. Ascites also predisposes life-threatening complication such as Spontaneous Bacterial Peritonitis (SBP).

Materials and Methods. 74 cirrhosis patients who develop ascites were included in the study. The ascitic fluid was cultured in aerobic and anaerobic media. Leukocytes were evaluated for leukocytes count using Sysmex XT2000iT"" automatic cell counter, leukocytes differential count was observed under the microscope, and dip stick urine of leukocyte esterase test. Moreover, albumin, protein, and LDH level were assessed for both serum and ascitic fluid.

Results. Spontaneous Bacterial Peritonitis was diagnosed in 14 subjects (18.92%). Twelve subjects (85.71%) within this group developed neutrocytic ascites. Enterobacteriaceae pathogens, i.e. Eschericiiia coil and Enterobacter aerogerles, had been isolated from the ascitic fluid culture. These pathogens were suspected for producing Extended Spectrum Beta Lactamase (ESBL). Using Bland-Altman test, it was discovered that there were no significant differences in leukocytes count of ascitic fluid either measured with Sysmex XT2000iT"' automatic cell counter or conventional method. The cut-off point for MultistixlOSGTm was set on trace scale, whereas the ComburlOMTM was set on scale positive-2 to obtain a number of PMN leukocytes count of more than 250 cellslpL. Based on Light criteria, 85.71% of ascitic fluid from the SBP patients were considered as transudates. Meanwhile, 92.86% of SBP group showed an SHAG ? 1.lg/dL.

Conclusions. The study reveals that the proportion of SBP is 18.92% and neutrocytic ascites is 85.71%. Both of the Gram-negative bacteria are considered producing ESBL that induce resistance to Cefotaxime. Leukocytes count of ascitic fluid can be measured using Sysmex XT2000iTM automatic cell counter. To predict PMN leukocyte count of more than 250 cells/pL, the dip stick urine leukocytes esterase test using MultistixlOSGT"^ and ComburlOMTM are available. The ascitic fluid in SBP patients are classified as transudates, based on Light criteria. SBP has no effect against SAAG.

Suggestions. A diagnostic paracentesis should be performed prior to empirical antibiotics therapy. The dip stick urine leukocytes esterase test can be use as an alternative method to diagnose SBP along with the other bedside techniques. Further study is required to attain pattern and sensitivity of SBP pathogens."

"This book addresses biometrics from a biomedical engineering point of view. Divided into five sections, it discusses topics including the influence of pathologies on various biometric modalities (e.g. face, iris, fingerprint), medical and security biometrics, behavioural biometrics, instrumentation, wearable technologies and imaging. The final chapters also present a number of case studies. "

"ABSTRAKTesis ini mengenai hubungan antara Persepsi Keselamatan dan Perilaku Keselamatan di Laboratorium Universitas. Banyaknya jumlah kecelakaan di Laboratorium membuat semakin jelas bahwa keselamatan adalah suatu hal yang penting untuk dibahas. Penelitian ini merupakan penelitian kuantitatif dengan menginvestigasi persepsi keselamatan dan perilaku keselamatan mahasiswa dalam menggunakan laboratorium dan berfokus pada mahasiswa yang aktif menggunakanlaboratorium. Uji regresi berganda digunakan untukmengetahui ada atau tidaknya hubungan antara persepsi keselamatan dan perilaku keselamatan di laboratorium universitas. Hasil penelitian menunjukkan bahwa terdapat hubungan yang signifikan antara persepsi keselamatan dan perilaku keselamatan di laboratorium universitas

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ABSTRACTThis research discussed about the Correlation of Safety Perceptions and Safety Behavior in University Teaching Laboratory. Numerous cases of laboratories incidents make it clear that safety in laboratories become an important issue to be discussed. This is a quantitative research, investigated the safety perceptions and safety behavior in laboratories usage and focused on students who regularly use laboratories. Multiple regression analysis was used to get the correlation between safety perceptions and safety behavior in university teaching laboratory. The result showed that safety perceptionssignificantly influence the safety behavior in university teaching laboratory"

"Planning construction of a new library facility or renovation of an existing one can be a daunting task. With the new fifth edition of his Checklist of Library Building Design Considerations, veteran library administrator and construction consultant William Sannwald guides librarians and other members of a building design team through the stages of the design process. Updated materials include# A new chapter on sustainable design, including issues of site selection, air quality, and energy and water efficiency# New sections on wireless networking, information commons and media production and presentation labs# Updated treatment of special collections and materials handling systems# A new section on disaster planning# ADA Accessibility Guidelines section reorganized to match structure of the federal statuteBecause construction projects are complex and sometimes unwieldy, Sannwald's checklist format provides a clear, concise way of itemizing the issues."