Hasil Pencarian  ::  Simpan CSV :: Kembali

"A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval. The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are: The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products Approaches to clinical trial protocol design and execution Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products Key sponsor/FDA meetings and negotiations essential for approval and commercialization Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes. "

"Guidebook for drug regulatory submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines.As well, vital information is provided on the most common types of submissions, including:- Meeting Requests- Orphan Drug Applications- Investigatory New Drug Applications (INDAs)- New Drug Applications (NDAs)- 505(b)2 NDAs- Abbreviated New Drug Applications (ANDAs)- Annual ReportThis reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia."

"This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries."

"Tesis ini membahas tentang strategis pembangunan sistem informasi pecandu narkotika yang merupakan usaha dalam pemutusan jaringan peredaran gelap narkoba,hal ini dapat diperoleh dari informasi yang diberikan oleh pecandu narkoba pada institusi penerima wajib lapor. Tujuan dari penelitian ini adalah untuk menganalisis pembangunan sistem informasi pecandu narkotika dengan mengeksplorasi faktor penghambat atau kendala yang dihadapi dalam pembangunan sistem informasi pecandu di BNN dan menganalisis prioritas strategi dalam menghadapi permasalahan yang ditemukan dalam proses pelaksanaannya. Pendekatan penelitian yang digunakan adalah pendekatan kuantitatif denganmetode analisis AHP (Analytic Hierarchy Process). Berdasarkan hasil analisis AHP, prioritas faktor penghambat atau kendala yang ditemukan dalam pembangunan sistem informasi pecandu narkotika adalah kriteria sumber daya manusia, kemudian arogansi antar instansi terkait, diikuti dengan stigma pecandu dan yang terakhir adalah anggaran/dana. Aktor yang berperan dalam pembentukan atau pembangunan sistem informasi pecandu narkotika adalah Badan Narkotika Nasional, diikuti dengan instansi terkait, dan faktor yang terakhir adalah pecandu narkotika. Perekrutan sdm yang ahli dan handal dalam pembangunan sistem informasi pecandu narkotika di BNN ini bukan berarti menyatakan bahwa strategi yang pertamadiperlukan dan strategi yang lain tidak diperlukan, tetapi penentuan prioritas ini hanya sebagai bantuan untuk menentukan strategi yang perlu didahulukan apabila untuk melakukan seluruh strategi secara simultan mengalami kendala. Bagaimanapun, pelaksanaan seluruh strategi secara simultan akan menghasilkan pencapaian tujuan yang lebih optimal.

---

This thesis discusses the development of strategic information system drug addict who is a business in illicit drug trafficking network disconnection, this can be obtained from the information provided by drug addicts at the recipient institution shall report. The goal of this study is to analyze development of strategic information system, explore the inhibiting factors or obstacles encountered in the development of information system in National Narcotics Board and analyze strategic priorty in dealing with problems that found in the implementation process. This study used a quantitative approach with Analytic Hierarchy Process (AHP) methode.

Based on AHP analysis, the priorityof inhibiting factors or constraints that are found in the construction of information systems is a drug addict human resource criteria, then arrogance among related institution, followed by stigma addicts and the last one is the budget. The actor who plays a role in the implementation of information systems development is a drug addict is a drug addict addict National Narcotics Board, followed by agencies, drug addicts.

Recruitmenr of human resourcers expert and reliable in drug addicts? information system developing strategic in BNN doesn?t mean that one strategy is more important than the other. It is only as a guidance to determine which strategy to do first when simultaneous implementation can not be done. However, implementation of all strategies simultaneously will make a better achievement."

"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."

"With its coverage of food and drug administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing."