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"This book answers the questions about the process and costs of pharmaceutical R & D in a compelling narrative focused on the discovery and development of important new medicines. It gives an insider's account of the pharmaceutical industry drug discovery process, the very real costs of misperceptions about the industry, the high stakes, both economic and scientific, of developing drugs, the triumphs that come when new compounds reach the market and save lives, and the despair that follows when new compounds fail. "

"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."

"ABSTRAKPemerintah Negara Euphoria telah mempertimbangkan untuk mendirikan pengadilannarkoba sebagai dampak dari penyalahgunaan narkoba di masyarakat Euphoria danperadilan pidana yang telah meningkat selama 10 tahun terakhir. Makalah non skripsi iniakan menentukan apakah Euphorian Drug Court Program(EDCP) dapat menguntungkannegara dengan menerapkan analisis biaya manfaat menggunakan pendekatan Brown danCampbell terhadap berbagai aspek negara, seperti Kementrian Hukum (Department ofJustice). Kementrian Hak Asasi Manusia (Department of Human Services), korban,keluarga korban, tamatan dari program tersebut dan masyarakat Euphoria.Kata Kunci: Pengadilan Narkoba, Analisis Biaya Manfaat, pendekatan Brown danCampbell

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ABSTRACTThe government of the State of Euphoria has been considering to establish a drug court asthe impact of drug abuse in the Euphorian community and the criminal justice system hasbeen increasing for the past 10 years. This report will determine if The Euphorian DrugCourt Project (EDCP) can benefit the state by implementing a benefit-cost analysis usingthe Brown and Campbell approach towards numerous aspects of the state, such as theDepartment of Justice (DoJ), the Department of Human Services, the victims and theirfamilies, the graduates of the project and the society."

"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.

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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."

"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."

"ABSTRAKIndustrialisasi dan ekspansi bisnis yang dijalankan dengan sistem pasar bebas di Amerika Serikat pada masa Progresif Era memberikan peluang kepada pebisnis produk makanan untuk melakukan tindak kecurangan. Ketiadaan regulasi dan standarisasi produk makanan membuat produsen makanan di Amerika Serikat leluasa untuk memproduksi dan menjual makanan yang tercemar. Skripsi ini menganalisis peran Kepala Biro Kimia Kementrian Agrikultur, Harvey Washington Wiley, dalam membangun kesadaran masyarakat untuk memperjuangkan undang-undang kemurnian makanan tingkat federal di Amerika Serikat pada kurun waktu 1902-1906. Hasil penelitian ini menunjukkan bahwa Harvey Washington Wiley merupakan agensi dalam perubahan regulasi bisnis produk makanan di Amerika Serikat pada tahun 1906. Dengan mengunakan metode sejarah dan pendekatan teori strukturasi milik Giddens, Penelitian ini akan menyelidiki upaya yang dilakukan oleh Harvey Washington Wiley sebagai agensi perubahan, dalam membentuk kesadaran publik dan merangkul berbagai golongan masyarakat yang terkait, guna melahirkan gerakan sosial yang menuntut keberadaan regulasi bisnis produk makanan pertama di Amerika Serikat.

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ABSTRACTThe industrialization and business expansion that run with free market system in United States during the Progressive Era, gives an opportunity for food manufacturers to commit fraud. The absence of food regulations and standarization gives a chance to food manufacturers in the United States to manufacture and sell adulterated food. This study analyzing the role of Harvey Washington Wiley as Head of Bureau Chemistry Department of Agriculture in building public awareness to fight for federal pure food law in the United States 1902 1906 . The result of this research, indicates that Harvey Washington Wiley is the agency in the pure food movement that fight for food business regulations in the United States. Using historical methods and the giddens 39 theory of structuration, this research investigate the efforts that made by Harvey Washington Wiley as agency, in forming public awareness and embrace various groups to join the pure food movement to deliver pressure to the congress to ratify the first Pure Food and Drug Act in United States."