Hasil Pencarian  ::  Simpan CSV :: Kembali

"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"

"By covering the full spectrum of topics relevant to peptidic drugs, this timely handbook serves as an introductory reference for both drug developers and biomedical researchers interested in pharmaceutically active peptides, presenting both the advantages and challenges associated with this molecular class.The first part discusses current approaches to developing pharmaceutically active peptides, including case studies of the use of peptidic drugs in cancer and AIDS therapy. The second part surveys strategies for the development and targeting of peptidic drugs.With its integration of biochemical, pharmaceutical and clinical research, this work reveals the full picture of modern peptide drug research in a single volume, making it an invaluable reference for medicinal chemists, biochemists, biotechnologists, and those in the pharmaceutical and biotechnological industries."

"The book introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter. This second edition has been completely revised to include the latest advances in drug discovery, development, clinical trials, manufacturing, and regulatory processes. At the end of each chapter is a case study to provide more in-depth perspectives and current issues facing the pharmaceutical industry.Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. "

"Contents : Drug discovery : targets and receptors -- Drug discovery : small molecule drugs -- Drug discovery : large molecule drugs -- Drug development and preclinical studies -- Clinical trial -- Regulatory authorities -- Regulatory applications -- Good manufacturing practice : regulatory requirements -- Good manufacturing practice : drug manufacturing -- Future perspectives."

"Tablet fluvastatin XL 80 mg telah dipasarkan di Indonesia sejak Desember 2002. Survei pasca pemasaran ini dilaksanakan antara Mei 2004 dan April 2005 dengan melibatkan 98 dokter umum untuk melihat keamanan dan tolerabilitas fluvastatin XL 80 mg sekali sehari sebelum tidur selama 8 minggu untuk pengobatan pasien rawat jalan dengan hiperkolesterolemia. Efikasi obat dalam menurunkan kolesterol LDL dan parameter lipid lainnya juga dilihat dalam praktek klinik sehari-hari pada survei ini. Seluruhnya ada 740 pasien yang dapat dievaluasi keamanannya. Sebanyak 32 pasien (4,32%) melaporkan 39 efek samping yang dianggap berhubungan dengan terapi fluvastatin XL. Efek samping yang paling sering adalah pusing kepala (2,03%), nausea (1,22%), dan mialgia (0,68%). Tidak ditemukan efek samping serius pada survei ini dan tidak ada pasien yang menghentikan pengobatan akibat efek samping. Menurut penilaian global dokter, keamanan dan tolerabilitas pengobatan baik pada 91,9% pasien. Evaluasi efikasi hanya dapat dilakukan pada 566 pasien. Pada minggu 8, fluvastatin XL menurunkan kadar kolesterol LDL (LDL-C), kolesterol total (TC) dan trigliserida (TG) berturut-turut sebanyak 28,6%, 30,2%, dan 24,5%, dan meningkatkan kadar kolesterol HDL (HDL-C) sebanyak 14,3%. Pada 74 pasien dengan TG awal > 300 mg/dL, penurunan TG 38,1% dan peningkatan HDL-C 18,1%. Penurunan LDL-C sebanyak > 40% terjadi pada 19,6% pasien. Sebagai kesimpulan, survei pasca pemasaran ini menunjukkan bahwa pengobatan dengan fluvastatin XL 80 mg sekali sehari selama 8 minggu aman dan dapat ditoleransi dengan baik, dan juga efektif dalam menurunkan LDL-C, TC dan TG, dan menaikkan HDL-C dalam praktek klinik sehari-hari.

---

AbstractFluvastatin XL 80 mg tablet has been marketed in Indonesia since December 2002. This post-marketing surveillance (PMS) was conducted between May 2004 and April 2005 involving 98 general physicians to observe the safety and tolerability of fluvastatin XL 80 mg once daily at bedtime for 8 weeks in the treatment of outpatients with hypercholesterolemia. The efficacy of the drug in lowering LDL-cholesterol and other lipid parameters was also observed in daily clinical practice in this PMS. A total of 740 patients were eligible for safety analyses. There were 32 patients (4.32%) with 39 adverse events that were considered related to fluvastatin XL therapy. The most common adverse reactions were dizziness (2.03%), nausea (1.22%), and myalgia (0.68%). No serious adverse event (SAE) was found in this PMS, and no patient discontinued due to adverse event. According to physician?s global evaluation, the safety and tolerability of treatment was good in 91.9% of patients. For efficacy analyses, only 566 patients were eligible. At week 8, fluvastatin XL caused decreases in LDL-cholesterol (LDL-C), total cholesterol (TC) and triglyceride (TG) levels by 28.6%, 30.2% and 24.5%, respectively, and an increase in HDL-cholesterol (HDL-C) by 14.3%. In 74 patients with baseline TG > 300 mg/dL, the decrease in TG was 38.1% and the increase in HDL-C was 18.1%. Reduction in LDL-C of > 40% occurred in 19.6% of the patients. In conclusion, treatment with fluvastatin XL 80 mg once daily for 8 weeks in this PMS was shown to be safe and well tolerated, and also effective in reducing LDL-C, TC and TG, and raising HDL-C in daily clinical practice."

"This volume covers all aspects of the antibiotic discovery and development process through Phase II/III. The contributors, a group of highly experienced individuals in both academics and industry, include chapters on the need for new antibiotic compounds, strategies for screening for new antibiotics, sources of novel synthetic and natural antibiotics, discovery phases of lead development and optimization, and candidate compound nominations into development. Beyond discovery , the handbook will cover all of the studies to prepare for IND submission : phase I (safety and dose ranging), progression to phase II (efficacy), and phase III (capturing desired initial indications). This book walks the reader through all aspects of the process, which has never been done before in a single reference. With the rise of antibiotic resistance and the increasing view that a crisis may be looming in infectious diseases, there are strong signs of renewed emphasis in antibiotic research. The purpose of the handbook is to offer a detailed overview of all aspects of the problem posed by antibiotic discovery and development."

"This book contains case studies of the discovery of erythromycin analogs (antibiotics), Tagamet, and Ultiva (remifentanil). Discusses the discovery of agents for the treatment and management of bacterial infections, Parkinson's disease, psoriasis, ulcers and stomach pain, atopic dermatitis, asthma, and cancer. Contains chapters on combinatorial chemistry, molecular biology-based drug discovery, genomics, and chemogenomics.The first volume of this set thoroughly describes conceptualizing a drug, creating a library of candidates for testing, screening those candidates for in vitro and in vivo activity, conducting and analyzing the results of clinical trials, and revising the drug as necessary."

"Summary:Covers Information Systems Development Context, the Systems Development Lifecycle, Themes of Systems Development, Techniques, Methodologies, Tools and Toolsets and Issues and Frameworks. This title analyzes context, issues and real-world problems associated with information systems developmen"