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Abstrak :
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.

Abstrak :
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.

Abstrak :
This book covers the methods and applications of bioassays in pharmaceutical science to quantify drug activity and evaluate the validity of models. It demonstrates the numerous systems available and that each system interprets the activity of drug molecules in different ways. The authors discuss the various models put forward to link the experimental observations and the events taking place on a cell or molecular level between the drug and experimental object, providing the principal and technological guide for successful research of drug research and clinical therapy.

Abstrak :
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.

Abstrak :
"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.

Abstrak :
All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applicable FDA code(s). Good Clinical Practice (GCP) Audit Preparation provides a step-by-step explanation of the FDA audit procedures for clinical trials and how a pharmaceutical company should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals.

Abstrak :
ExpDesign Studio facilitates more efficient clinical trial design. This book introduces pharmaceutical statisticians, scientists, researchers, and others to ExpDesign Studio software for classical and adaptive designs of clinical trials. It includes the Professional Version 5.0 of ExpDesign Studio software that frees pharmaceutical professionals to focus on drug development and related challenges while the software handles the essential calculations and computations. After a hands-on introduction to the software and an overview of clinical trial designs encompassing numerous variations, Classical and adaptive clinical trial designs using ExpDesign Studio:* Covers both classical and adaptive clinical trial designs, monitoring, and analyses* Explains various classical and adaptive designs including groupsequential, sample-size reestimation, dropping-loser, biomarker-adaptive, and response-adaptive randomization designs* Includes instructions for over 100 design methods that have been implemented in ExpDesign Studio and step-by-step demos as well as real-world examples* Emphasizes applications, yet covers key mathematical formulations* Introduces readers to additional toolkits in ExpDesign Studio that help in designing, monitoring, and analyzing trials, such as the adaptive monitor, graphical calculator, the probability calculator, the confidence interval calculator, and more* Presents comprehensive technique notes for sample-size calculation methods, grouped by the number of arms, the trial endpoint, and the analysis basis Written with practitioners in mind, this is an ideal self-study guide for not only statisticians, but also scientists, researchers, and professionals in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies. It's also a go-to reference for biostatisticians, pharmacokinetic specialists, and principal investigators involved in clinical trials.

Abstrak :
This book guides medicinal chemists in how to implement early ADMET testing in their workflow in order to improve both the speed and efficiency of their efforts. Although many pharmaceutical companies have dedicated groups directly interfacing with drug discovery, the scientific principles and strategies are practiced in a variety of different ways. This book answers the need to regularize the drug discovery interface; it defines and reviews the field of ADME for medicinal chemists. In addition, the scientific principles and the tools utilized by ADME scientists in a discovery setting, as applied to medicinal chemistry and structure modification to improve drug-like properties of drug candidates, are examined.

Abstrak :
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.