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"Drug Safety Evaluation has been written with the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, health care providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated."

"This is the definitive, one-stop resource on preclinical drug evaluation for potential mitochondrial toxicity, addressing the issue upfront in the drug development process. It discusses mitochondrial impairment to organs, skeletal muscle, and nervous systems and details methodologies used to assess mitochondria function. It covers both in vitro and in vivo methods for analysis and includes the latest models. "

"This thesis demonstrates a technology that enables pipetting-free high-throughput screening (HTS) on a miniaturized platform, eliminating the need for thousands of one-by-one pipetting and conventional liquid handling systems. This platform enhances accessibility to HTS and enables HTS to be used in small-to-medium scale laboratories. In addition, it allows large-scale combinatorial screening with a small number of valuable cells, such as patients primary cancer cells. This technique will have a high impact for widespread use of HTS in the era of personalized medicine.In this thesis, the author firstly describes the need and concept of partipetting for pipetting-free HTS platform. It is realized by the one-step pipetting and self-assembly of encoded drug-laden microparticles (DLPs) on the microwells. Next, the technical implementations required for the platform demonstration are described. It includes preparation of encoded DLPs, plastic chip fabrication, and realization of automated system. Lastly, screening of sequential drug combinations using this platform is demonstrated. This shows the potential of the proposed technology for various applications. "

""This book presents a structural approach to the evaluation of herbal medicinal products for quality, safety and efficacy. There has been an enormous growth in the market for herbal medicinal products in the last twenty five years. However the rediscovery of natural substances with therapeutic potential has raised questions of quality, safety and efficacy on the part of the consumer and also from health professionals. This book brings together current thinking and practice in these areas highlighting current research. In the light of increasing legislation to enforce better standards for these products and the demand by legislators and the public for assurance of safe and effective use, this book seeks to provide a state-of-the-art review, which informs and guides those who seek to promote their use. This book also gives an overview of the place of ethno pharmacology in the development of herbal medicinal products and discusses good agricultural and collection practices, marker analysis and stability testing which contribute to assessment of good quality of these materials." -- Publisher description."

"This book covers both recent advances in the design and synthesis of new drugs, as well as the myriad other issues facing a new drug candidate as it moves through the development process. Utilizing recent case studies, the authors provide valuable insights into the complexities of the process, from designing new synthetic methodologies and applying new automated techniques for finding optimal reaction conditions to selecting the final drug form and formulation."

"This book focuses on the analysis of dose-response microarray data in pharmaceutical settings, the goal being to cover this important topic for early drug development experiments and to provide user-friendly R packages that can be used to analyze this data. It is intended for biostatisticians and bioinformaticians in the pharmaceutical industry, biologists, and biostatistics/bioinformatics graduate students.Part I of the book is an introduction, in which we discuss the dose-response setting and the problem of estimating normal means under order restrictions. In particular, we discuss the pooled-adjacent-violator (PAV) algorithm and isotonic regression, as well as inference under order restrictions and non-linear parametric models, which are used in the second part of the book. Part II is the core of the book, in which we focus on the analysis of dose-response microarray data. All methodological issues in the book are illustrated using real-world examples of dose-response microarray datasets from early drug development experiments."

"Rebamipid tergolong suatu obat antiulkus yang masuk dalam kategori obat wajib uji Bioekivalensi (BE) menurut Food and Drug Administration (FDA). Penelitian ini bertujuan untuk memperoleh kondisi optimum untuk analisis rebamipid dalam plasma in vitro menggunakan Kromatografi Cair Kinerja Tinggi (KCKT) detektor ultraviolet dan melakukan validasi metode analisis tersebut. Kromatografi dilaksanakan dengan teknik isokratik pada kolom fase terbalik Kromasil® C18 (5 μm, Akzo Nobel) panjang kolom 250 x 4,6 mm, fase gerak asetonitril-dapar fosfat pH 3,0 (40:60), dengan kecepatan alir 1,0 ml/menit, dan dideteksi pada panjang gelombang 230 nm. Teknik penyiapan sampel dilakukan dengan cara ekstraksi cair-cair menggunakan asam fosfat dan etil asetat. Karbamazepin digunakan sebagai baku dalam. Metode ini valid menurut FDA dalam Bioanalytical Method Validation, dengan nilai koefisien korelasi r = 0,9993 dan linier pada kisaran konsentrasi 0,04 ? 1,2 ìg/ml, batas terendah kuantitasi (LLOQ) 42,0 ng/ml, presisi kurang dari 6%, dan nilai perolehan kembali antara 90,32 sampai 113,45%. Rebamipid stabil dalam plasma selama 14 hari penyimpanan pada suhu -200C.

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Rebamipide is antiulcer agent and it is one of the drug that have to be evaluated with bioequivalency test according to Food and Drug Administration (FDA). The objective of this research is to find out the optimum condition of rebamipide in human plasma in vitro analysis by High Performance Liquid Chromatography (HPLC) with ultraviolet detector, and then the method was validated. The chromatography was carried out by isocratic technique on a reversed-phase Kromasil® C18 (5 μm, Akzo Nobel), column length was 250 x 4.6 mm, with mobile phase consisted of acetonitrile - phosphate buffer pH 3.0 (40:60) at flow rate of 1.0 ml/min, and detection was performed at wavelength of 230 nm. The sample preparation technique was liquidliquid extraction by phosphoric acid and ethyl acetate. Carbamazepine was used as the internal standard. The method was valid according to FDA in Bioanalitycal Method Validation, with coefficient correlation of 0.9993 and linear in the range concentration of 0.04 ? 1.2 μg/ml, the lower limit of quantitation was 42.0 ng/ml, precision less than 6% and recovery percentage was 90.32 to 113.45%. Rebamipide in plasma was stable for 14 days storage in -200C."

"Immunotoxicology is a highly specialized discipline that addresses potential adverse effects on the immune system, including immunosuppression, immunogenicity, hypersensitivity and other immune system functional disorders. A broad spectrum of xenobiotics, including agents present in our environment as well as pharmaceutical molecules may adversely affect the immune system."

"Human interaction with the environment remains one of the most pervasive facets of modern society. In a world characterized by rapid population growth, unprecedented global trade and digital communications, energy security, natural resource scarcities, climatic changes and environmental quality, emerging diseases and public health, biodiversity and habitat modifications are routinely touted by the popular press as they canvas global political agendas and scholarly endeavors."