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Real-World Evidence in Drug Development and Evaluation
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the p...
Only You (Part 1)
Only You (Part 1) PENULIS: Dinara Ayning Tebal : 220 halaman ISBN : 978-623-7477-57-0 www.guepedia.com Sinopsis: Bisa bertemu dengan seorang pria seperti Harry adalah suatu hal yang tidak diinginkan oleh Kendall. Pertemuan pertamanya dengan Harry yang tidak berkesan baik, membuat Kendall menolak mentah-mentah untuk tidak akan mau lagi bertemu dengan pria itu. Lain halnya dengan Harry. Bisa dibilang Harry sudah menyukai Kendall sejak pandangan pertama. Pertemuan pertamanya dengan Kendall merupakan suatu hal yang tidak akan pernah dia tolak untuk terjadi, dan sudah pasti dia tidak akan pernah menolak jika akan bertemu dengan Kendall lagi. Kemudian tanpa diduga, Kendall yang sangat berharap untuk tidak lagi bertemu dengan pria itu, justru semakin sering dipertemukan dengannya. Hal itu terjadi karena kedua orangtua Harry dan juga Kendall sepakat untuk menjodohkan mereka berdua. www.guepedia.com Email : guepedia@gmail.com WA di 081287602508 Happy shopping & reading Enjoy your day, guys
Design and Analysis of Pragmatic Trials
This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage. It discusses the advantages and disadvantages of each type of PCT, and provides sample size formulas, sensitivity analyses, and examples for sample size calculation. The generalized estimating equation (GEE) method will be employed to derive sample size formulas for various types of outcomes from the exponential family, including continuous, binary, and count variables. Experimental designs that have been frequently employed in PCTs will be discussed, including cluster randomized designs, matched-pair cluster ...
Biosimilars
This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for...
Ghostly Muscles, Wrinkled Brains, Heresies and Hobbits
The Leverhulme Trust (UK) required Charles Oxnard to present a series of public lectures during his tenure of a Leverhulme Professorship at University College, London. The lectures had to be understandable not only to undergraduate and graduate students and colleagues, but also to the interested lay public. Furthermore, they were expected to meet and venture beyond present-day thought in the subject. This near-impossible task is reproduced in this unique volume.Each chapter shows what is rarely, if ever, done in scientific papers: how the problems truly arose; how the methods came about; the curious collaborators involved; the twists and turns of thought involved in the stories; the solutions that have so far appeared; and the surprising new ideas that stem from the work. In particular, the part played by serendipity becomes ever more evident. Research is very often a kind of ?Alice-in-Wonderland? task, and both students and the public alike are fascinated by the inside stories of how discoveries are really made. It is precisely this excitement and complexity that is presented in this book.
Assassin's Trap
MI-5 agent John Brock is back in this explosive thriller that pits him against a ruthless enemy from the past. Using his cunning, expertise, and international contacts, Brock, head of counterterrorism for Great Britain's secret service, uncovers a trail of industrial espionage that leads from Beijing to Mumbai and, finally, to an international summit in Vancouver. But Brock's pursuit of the nations' enemies is disrupted by a threat to his own life-and his wife's. Stalked by danger, Brock is ruthlessly pursued across the globe by a band of assassins hired by an unknown adversary. Someone on his long list of enemies wants him dead; Brock seeks clues to his nemesis in India, Norway, and even South Korea. Brock risks everything to protect his beloved wife from the demons of his past. But when she falls victim to his enemy, will Brock be able to save her or will the assassin's trap end it all? From the dark streets of London to the backwater villages of South Korea, Assassin's Trap delivers a fast-paced, gripping story of one man's fight to protect the woman he loves.
Asmara Berujung Petaka (Deadly Affair)
A Deadly Affair menyajikan sisi-sisi gelap cintaÑpermainan hati, kemarahan yang membabi buta, dan asmara yang mematikanÑyang melibatkan tokoh-tokoh detektif kecintaan para pembaca Agatha Christie, seperti Hercule Poirot, Miss Marple, Parker Pyne, Harley Quin, serta Tommy dan Tuppence. Dalam cerita pendek ÒWajah HelenÓ, seorang wanita ketahuan terlibat cinta segitiga di Royal Opera; dalam ÒMenyiasati RajaÓ sebuah iklan di rubrik personal menjadi topeng untuk tujuan yang keji; siapa yang berisiko tersengat dalam ÒSarang LebahÓ tergantung pada kemampuan sang detektif mengumpulkan para tersangka dan memecahkan kasus pembunuhan yang belum terjadi; dan masih banyak lagi kisah-kisah misteri kriminal bertema cinta yang bisa memuaskan kerinduan para pembaca Agatha Christie.
Imaji
Selamat datang di dunia imaji! Ini adalah dunia yang akan membawamu menembus batas realitas. Di sini, ilusi hadir untuk menghidupkan fakta. Di sini pula, kau akan menyaksikan pertempuran akbar dengan tangan hampa, mendengar apa yang bisa dikisahkan sebuah cermin, mencecap magis yang menentang logika. Kumpulan kisah dalam Imaji akan mengantarmu menuju gerbang kisah tak terbayangkan.
Alinea Media Pustaka; Life of Joy
Ya Tuhan, kenapa aku harus bertemu dengannya? Kenapa aku harus mengenalnya dan jatuh untuk mencintainya begitu dalam? “Aku nggak punya masa depan sama kamu, Harry. Apa yang menjadi impianku adalah mimpi buruk bagimu. Aku ingin menikah dan memiliki sebuah keluarga dan semua itu tidak akan pernah terwujud bersamamu.” -Joy Collins- “Maafkan aku, Sun ... tolong, bertahan. Aku mencintaimu. Aku akan memperbaiki semuanya, memperbaiki hubungan kita. Aku mencintaimu dengan cara yang salah, maafkan aku, Sun. Bertahan, Sayang ....” -Harry Steels-
