Búsqueda de LIBROS DEL AUTOR: shein

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  • INNOVATIVE METHODS FOR RARE DISEASE DRUG DEVELOPMENT
    ebook
    INNOVATIVE METHODS FOR RARE DISEASE DRUG DEVELOPMENT
    SHEIN-CHUNG CHOW
    In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because there are only limited number of subjects available for clinical trials. In this cas...

    $1,360.00

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  • INNOVATIVE STATISTICS IN REGULATORY SCIENCE
    ebook
    INNOVATIVE STATISTICS IN REGULATORY SCIENCE
    SHEIN-CHUNG CHOW
    Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical produ...

    $1,380.00

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  • ANALYTICAL SIMILARITY ASSESSMENT IN BIOSIMILAR PRODUCT DEVELOPMENT
    ebook
    ANALYTICAL SIMILARITY ASSESSMENT IN BIOSIMILAR PRODUCT DEVELOPMENT
    SHEIN-CHUNG CHOW
    This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models...

    $1,480.00

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  • ENCYCLOPEDIA OF BIOPHARMACEUTICAL STATISTICS - FOUR VOLUME SET
    ebook
    ENCYCLOPEDIA OF BIOPHARMACEUTICAL STATISTICS - FOUR VOLUME SET
    SHEIN-CHUNG CHOW
    Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requi...

    $30,000.00

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  • ADVANCED LINEAR MODELS
    ebook
    ADVANCED LINEAR MODELS
    SHEIN-CHUNG CHOW / SONG-GUI WANG
    This work details the statistical inference of linear models including parameter estimation, hypothesis testing, confidence intervals, and prediction. The authors discuss the application of statistical theories and methodologies to various linear models such as the linear regression model, the analysis of variance model, the analysis of covariance model, and the variance compon...

    $4,000.00

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  • SAMPLE SIZE CALCULATIONS IN CLINICAL RESEARCH
    ebook
    SAMPLE SIZE CALCULATIONS IN CLINICAL RESEARCH
    SHEIN-CHUNG CHOW / JUN SHAO / HANSHENG WANG / YULIYA LOKHNYGINA
    Praise for the Second Edition: "… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for q...

    $1,200.00

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  • CONTROVERSIAL STATISTICAL ISSUES IN CLINICAL TRIALS
    ebook
    CONTROVERSIAL STATISTICAL ISSUES IN CLINICAL TRIALS
    SHEIN-CHUNG CHOW
    In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials cov ...

    $1,360.00

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  • QUANTITATIVE METHODS FOR TRADITIONAL CHINESE MEDICINE DEVELOPMENT
    ebook
    QUANTITATIVE METHODS FOR TRADITIONAL CHINESE MEDICINE DEVELOPMENT
    SHEIN-CHUNG CHOW
    In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine. Quantitative Methods for Traditional Chinese Medicine Development is the first book entirely devoted t...

    $1,800.00

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  • DESIGN AND ANALYSIS OF CLINICAL TRIALS
    ebook
    DESIGN AND ANALYSIS OF CLINICAL TRIALS
    SHEIN-CHUNG CHOW / JEN-PEI LIU
    Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and in...

    $1,903.00

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  • DESIGN AND ANALYSIS OF CLINICAL TRIALS
    ebook
    DESIGN AND ANALYSIS OF CLINICAL TRIALS
    SHEIN-CHUNG CHOW
    Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and in...

    $1,903.00

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  • BIOSIMILARS
    ebook
    BIOSIMILARS
    SHEIN-CHUNG CHOW
    As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manuf ...

    $1,800.00

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  • ADAPTIVE DESIGN METHODS IN CLINICAL TRIALS
    ebook
    ADAPTIVE DESIGN METHODS IN CLINICAL TRIALS
    SHEIN-CHUNG CHOW / MARK CHANG
    With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clini ...

    $1,320.00

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  • DESIGN AND ANALYSIS OF BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES
    ebook
    DESIGN AND ANALYSIS OF BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES
    SHEIN-CHUNG CHOW / JEN-PEI LIU
    Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequiva ...

    $1,320.00

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  • STATISTICAL DESIGN AND ANALYSIS OF STABILITY STUDIES
    ebook
    STATISTICAL DESIGN AND ANALYSIS OF STABILITY STUDIES
    SHEIN-CHUNG CHOW
    The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta ...

    $1,360.00

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  • DESIGN AND ANALYSIS OF ANIMAL STUDIES IN PHARMACEUTICAL DEVELOPMENT
    ebook
    DESIGN AND ANALYSIS OF ANIMAL STUDIES IN PHARMACEUTICAL DEVELOPMENT
    SHEIN-CHUNG CHOW
    "Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examp ...

    $1,360.00

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  • WORLD OF TANKS - THE T-34 GOES TO WAR
    ebook
    WORLD OF TANKS - THE T-34 GOES TO WAR
    D. SHEIN / A. ULANOV
    In 2012, the company that created World of Tanks, the phenomenal worldwide massive, multi-player online game, started publishing a series of books in Russian that utilized Soviet documents and archival materials that had never before been seen by outsiders or published in any language about the design, procurement, development, manufacturing, and combat employment of Soviet arm...

    $307.05

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  • ZERO-DAY EXPLOIT:: COUNTDOWN TO DARKNESS
    ebook
    ZERO-DAY EXPLOIT:: COUNTDOWN TO DARKNESS
    SHEIN, ROB
    The realistic portrayals of researching, developing, and ultimately defending the Internet from a malicious "Zero-Day" attack will appeal to every corner of the IT community. Although finctional, the numerous accounts of real events and references to real people will ring true with every member of the security community. This book will also satisfy those not on the "inside" of ...

    $661.00

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  • PEGADAS NA AREIA
    ebook
    PEGADAS NA AREIA
    ERIK DANIEL SHEIN
    Um pequeno elefante, uma enorme aventura...   A busca por aventura pode fazer com que Thunder encontre mais do que buscava. Ele não espera ficar sozinho novamente, mas as pegadas deixadas por sua mãe irão lhe guiar para a sua cura e para encontrar seu caminho. Em sua jornada, ele acaba fazendo alguns novos amigos: Razor, um leão rabugento; Dash, um geneta ágil; Archie, um lagar...

    $76.00

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  • LE AVVENTURE DI THUNDER
    ebook
    LE AVVENTURE DI THUNDER
    ERIK DANIEL SHEIN
    Thunder è un cucciolo di elefante pigmeo che vive una vita spensierata nella giungla africana. Un giorno tutto viene sconvolto dall'arrivo degli esseri umani, che lo separano dal suo branco e dalla sua famiglia. Per ritrovarli, Thunder dovrà intraprendere un viaggio attraverso i meravigliosi paesaggi africani, incontrando animali di tutte le specie e imparando a conoscere sé st...

    $76.00

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  • LE VOYAGE D’UN ÉLÉPHANT, TONNERRE
    ebook
    LE VOYAGE D’UN ÉLÉPHANT, TONNERRE
    ERIK DANIEL SHEIN ET MELISSA DAVIS
    Un petit éléphant, une aventure grandiose... A force de chercher l'aventure, Tonnerre vit un évènement terrible. Il ne s'attendait pas du tout à se retrouver à nouveau seul, mais les empreintes laissées par sa mère le guideront pour guérir ses douleurs et retrouver son chemin. Au cours de son voyage, il se fera de nouveaux amis : Rasoir, un lion grincheux ; Dash, un genet rapid...

    $76.00

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  • AVENTURAS DO ELEFANTE THUNDER TUSKER
    ebook
    AVENTURAS DO ELEFANTE THUNDER TUSKER
    ERIK DANIEL SHEIN E MELISSA DAVIS
    Segue-se abaixo a descrição com base no texto traduzido. Capítulo 02, página 08, linha 3 – A palavra “splash” não foi traduzida, sendo melhor empregada na forma original; Capítulo 04, página 17, linha 13-14 – As palavras “high above” estão escritas juntas no original; Capítulo 06, página 25, linha 38 – Nota de rodapé seria bem empregada para uma melhor compreensão do leitor. A ...

    $76.00

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  • AVENTURAS DO ELEFANTE THUNDER
    ebook
    AVENTURAS DO ELEFANTE THUNDER
    ERIK DANIEL SHEIN
    Baseado em fatos reais, este livro é uma obra de ficção. As personagens, os acontecimentos, os diálogos são frutos da imaginação do autor e não devem ser interpretados como na vida real. Qualquer semelhança a casos reais ou pessoas, vivas ou mortas, é inteiramente mera coincidência. ...

    $76.00

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  • REFÚGIO DA ESPERANÇA
    ebook
    REFÚGIO DA ESPERANÇA
    ERIK DANIEL SHEIN AND MELISSA DAVIS
    Uma história de perseverança e coragem... Thunder está na busca final para cumprir o seu destino. Encarregado de encontrar o Refúgio da Esperança, Thunder parte para descobrir o mistério do Refúgio da Esperança com seus amigos Razor, um leão solitário; Dash, uma gineta manchada; e Archie, um lagarto negro. Quando descobrem que o Refúgio da Esperança é um santuário para animais ...

    $76.00

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  • THUNDER: L'ELEFANTE VIAGGIATORE - L'OASI DELLA SPERANZA
    ebook
    THUNDER: L'ELEFANTE VIAGGIATORE - L'OASI DELLA SPERANZA
    ERIK DANIEL SHEIN
    Il tuono è alla ricerca definitiva per compiere il suo destino. Incaricato di trovare Hope Haven, Thunder inizia a scoprire il mistero di Hope Haven con i suoi amici Razor, un leone solitario; Dash, un genet maculato; e Archie, una lucertola monitor nera fasciata. Quando scoprono che Hope Haven è un santuario per animali abbandonati e feriti, Thunder si imbatte in più di quanto...

    $89.00

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  • TONNERRE
    ebook
    TONNERRE
    ERIK DANIEL SHEIN
    Dès le moment où Tonnerre fit ses premiers pas, il était clair que ses pas marqueraient le monde qui l'entoure. La vie de ce petit éléphant était quasiment parfaite jusqu’à ce que des braconniers la chamboulent. Pendant une nuit fatidique dans la forêt tropicale africaine, ils surprirent son troupeau et le séparèrent de sa mère et du reste de son troupeau. Après une évasion pén...

    $77.00

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  • IMPRONTE SULLA SABBIA
    ebook
    IMPRONTE SULLA SABBIA
    ERIK DANIEL SHEIN / MELISSA DAVIS
    Un piccolo elefante, una gigantesca avventura… La ricerca dell’avventura offrirà a Thunder più occasioni di quante potesse aspettarsi. Non avrebbe mai immaginato di ritrovarsi ancora una volta solo, ma le impronte lasciate da sua madre sulla sabbia gli faranno da guida per trovare la sua strada e cominciare una nuova vita. Durante il viaggio stringerà nuove amicizie: Razor, un ...

    $59.00

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  • BRAZALETE CAPIBARA DE PELUCHE
    BRAZALETE CAPIBARA DE PELUCHE
    SHEIN
    Muñeco de peluche de Capibara acostado con diseño de patas adorables, lindo muñeco de peluche para adolescentes, peluche de Capibara, patas, muñeco, Capibara, peluche de Capibara, Capibara de peluche ...
    Agotado

    $140.00

  • CAPIBARA DE PELUCHE CON MOCHILA DE TORTUGA EN ESPALDA
    CAPIBARA DE PELUCHE CON MOCHILA DE TORTUGA EN ESPALDA
    SHEIN
    Un capibara muy lindo y divertido. El capibara lleva una tortuga en su espalda. Perfecto para regalar a amigos durante las fiestas. Un capibara. Perezoso. Un regalo de Navidad. Un regalo de cumpleaños. Un regalo de fiesta. Varios regalos festivos ...
    Agotado

    $250.00

  • MOCHILA DE DIBUJOS DE CAPIBARA
    MOCHILA DE DIBUJOS DE CAPIBARA "HAPPY DAYS"
    SHEIN
    Mochila de dibujos animados de Capibara, mochila ligera de moda para niños, mochila escolar elegante para niñas, mochila de jardín de infantes para niños pequeños ...
    Agotado

    $280.00

  • PELUCHE DE CAPIBARA CON TURBANTE DE FRESA
    PELUCHE DE CAPIBARA CON TURBANTE DE FRESA
    SHEIN
    Muñeco de peluche lindo de capibara. Un animal de peluche de capibara con un turbante de fresa. Muñeco de peluche suave de capibara para que los niños tengan compañía. Perfecto para tus amigos y niños. Regalos de Navidad. Regalos de Halloween. Regalo del Día del Niño. Regalo de fiesta ...
    Agotado

    $250.00


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