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"This book examines genotoxic impurities and their impact on the pharmaceutical industry.Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed byasection on safety aspects, including safety tests in vivo and vitro, and data interpretation.The second section addresses the risk posed by genotoxic impurities fromoutside sources and from mutagenswithin DNA.In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities."

"The essentials of drug metabolism vital to developing new therapeutic entities.Information on the metabolism and disposition of candidate drugs is a critical part of all aspects of the drug discovery and development process. Drug metabolism, as practiced in the pharmaceutical industry today, is a complex, multidisciplinary field that requires knowledge of sophisticated analytical technologies and expertise in mechanistic and kinetic enzymology, organic reaction mechanism, pharmacokinetic analysis, animal physiology, basic chemical toxicology, preclinical pharmacology, and molecular biology. With chapters contributed by experts in their specific areas, this reference covers :- Basic concepts of drug metabolism- The role of drug metabolism in the pharmaceutical industry- Analytical techniques in drug metabolism- Common experimental approaches and protocolsDrug metabolism in drug design and development emphasizes practical considerations such as the data needed, the experiments and analytical methods typically employed, and the interpretation and application of data. Chapters highlight facts, common protocols, detailed experimental designs, applications, and limitations of techniques."

"Praktek klinik lanjut selama praktek residensi keperawatan pada sistem imunologi dimaksudkan untuk mampu memberikan asuhan keperawatan, menerapkan Evidence Based Nursing (EBN) serta mampu berperan sebagai inovator di ruang perawatan. Residen melakukan asuhan keperawatan dengan kasus kelolaan utama menggunakan pendekatan teori adaptasi Roy dan 30 kasus resume menggunakan pendekatan teori Bandura. Dari hasil kasus kelolaan utama, diagnosa keperawatan utama yang muncul adalah defisit nutrisi sehingga intervensi utama keperawatan fokus pada manajemen nutrisi. Dari kasus resume masalah keperawatan yang paling banyak ditemukan yaitu ketidakpatuhan pengobatan. Intervensi keperawatan dukungan kepatuhan program pengobatan ditujukkan untuk meningkatkan kepatuhan pengobatan. Selain itu, intervensi yang dilakukan adalah melakukan proyek inovasi keperawatan berupa penerapan konseling pengobatan ART terstruktur dalam meningkatkan kepercayaan diri perawat serta kepatuhan pengobatan pasien. Evidence Based Nursing yang telag dilakukan residen adalah melakukan uji validitas dan reliabilitas PHQ-9 untuk skrining depresi yang menunjukkan bahwa PHQ-9 valid dan reliabel dalam mendeteksi depresi pada pasien dengan HIV.

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Advanced clinical practice during nursing residency practice in the immunology system is intended to be able to provide nursing care, implement Evidence Based Nursing (EBN) and as an innovator. Resident conducts nursing care with main cases using Roy's adaptation theory approach and 30 cases resumes using Bandura theory approach. From the results of the main case, the main nursing diagnosis was nutritional deficit so nursing interventions focused on nutritional management. From the case of resume, the most common nursing problem found was non-adherence. Nursing interventions is adherence support are aimed to improve treatment adherence. In addition, the nursing intervention was innovation project structured ART treatment counseling to increase nurse confidence and patient treatment compliance. Evidence Based Nursing that has been done by residents is to test the validity and reliability of PHQ-9 for depression screening which shows that PHQ-9 is valid and reliable in detecting depression in patients with HIV."

"The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research. The integrated approach to cardiac safety presented by Turner and Durham should be of interest and value to all concerned with the drug discovery, development, marketing, and surveillance phases of the pharmaceutical endeavor. During the past two to three decades, the pharmaceutical industry has adopted a progressively more integrated approach to the drug discovery process"

"Polifarmasi merupakan penggunaan bersamaan enam obat atau lebih oleh seorang pasien. Semakin banyak obat yang digunakan maka semakin tinggi potensi interaksi yang terjadi dan dapat menyebabkan efek samping yang berbahaya. Tujuan dari penelitian ini adalah mengetahui resiko efek samping dan potensi interaksi obat pada resep polifarmasi nonracikan. Identifikasi terkait potensi efek samping dan interaksi obat dinilai berdasarkan database dari Medscape Drug Interaction Checker, RxList Drug Interaction Checker, drugs.com Drug Interaction Checker, dan WebMD Drug Interaction Checker. Pada resep polifarmasi nonracik pertama ditemukan potensi efek samping berupa ketidakseimbangan elektrolit, hipotensi, hiperurisemia, asam urat, sakit kepala, dan mual/muntah serta terdapat dua potensi interaksi major dan empat potensi interaksi moderate. Sementara pada resep polifarmasi nonracik kedua ditemukan potensi efek samping berupa pencernaan yang terganggu, mengantuk, tremor otot rangka, peningkatan BUN atau kreatinin, dan bronkospasme serta terdapat lima potensi interaksi moderate. Berdasarkan mekansimenya, mayoritas potensi interaksi obat yang ditemukan adalah interaksi farmakodinamik (45.4%). Sementara berdasarkan tingkatannya, mayoritas potensi interaksi obat yang ditemukan adalah interaksi moderate (81.8%).

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Polypharmacy is the concomitant use of six or more drugs by a patient. The more drugs used, the higher the potential for interactions that occur and can cause dangerous side effects. The purpose of this study was to determine the risk of side effects and potential drug interactions in nonconcocted polypharmacy prescriptions. Identification of potential side effects and drug interactions is assessed based on databases from Medscape Drug Interaction Checker, RxList Drug Interaction Checker, drugs.com Drug Interaction Checker, and WebMD Drug Interaction Checker. In the first non-mixed polypharmacy prescription, potential side effects were found in the form of electrolyte imbalance, hypotension, hyperuricemia, gout, headache, nausea, and vomiting, and there were two potential major interactions and four potential moderate interactions. While the second non-mixed polypharmaceutical prescription found potential side effects in the form of disturbed digestion, drowsiness, skeletal muscle tremors, increased BUN or creatinine, and bronchospasm, there were five potential moderate interactions. Based on the mechanism, the majority of potential drug interactions found were pharmacodynamic interactions (45.4%). Based on the level, the majority of potential drug interactions found were moderate (81.8%)."