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Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualized" protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design. Considers multiple digital and virtual strategies. Explores best practices, including the use of reduced patient involvement. Brings together expert, trusted information to increase the efficiency and effectiveness of clinical trials.

Drugs --- Drug development --- Clinical trials. --- Clinical Trials as Topic. --- Drug Design. --- Drug Approval. --- SARS-CoV-2. --- 2019-nCoV --- 2019 Novel Coronavirus --- COVID-19 Virus --- Coronavirus Disease 2019 Virus --- SARS Coronavirus 2 --- SARS-CoV-2 Virus --- Severe Acute Respiratory Syndrome Coronavirus 2 --- Wuhan Coronavirus --- Wuhan Seafood Market Pneumonia Virus --- 2019 Novel Coronaviruses --- COVID 19 Virus --- COVID-19 Viruses --- Coronavirus 2, SARS --- Coronavirus, 2019 Novel --- Coronavirus, Wuhan --- Novel Coronavirus, 2019 --- SARS CoV 2 Virus --- SARS-CoV-2 Viruses --- Virus, COVID-19 --- Virus, SARS-CoV-2 --- Food and Drug Administration Drug Approval --- Food and Drug Administration Drug Approval Process --- New Drug Approval Process --- Drug Approval Process --- New Drug Approval --- Approval Process, Drug --- Approval Processes, Drug --- Approval, Drug --- Approval, New Drug --- Approvals, Drug --- Approvals, New Drug --- Drug Approval Processes --- Drug Approval, New --- Drug Approvals --- Drug Approvals, New --- New Drug Approvals --- Process, Drug Approval --- Processes, Drug Approval --- Clinical Trials as Topic --- Off-Label Use --- Computer-Aided Drug Design --- Computerized Drug Design --- Drug Modeling --- Pharmaceutical Design --- Computer Aided Drug Design --- Computer-Aided Drug Designs --- Computerized Drug Designs --- Design, Computer-Aided Drug --- Design, Computerized Drug --- Design, Drug --- Design, Pharmaceutical --- Designs, Computer-Aided Drug --- Designs, Computerized Drug --- Designs, Drug --- Designs, Pharmaceutical --- Drug Design, Computer-Aided --- Drug Design, Computerized --- Drug Designs --- Drug Designs, Computer-Aided --- Drug Designs, Computerized --- Drug Modelings --- Modeling, Drug --- Modelings, Drug --- Pharmaceutical Designs --- Clinical Trial as Topic --- Clinical Protocols --- Drug Evaluation --- Drugs, Investigational --- Clinical Trials Data Monitoring Committees --- Therapies, Investigational --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical medicine --- Human experimentation in medicine --- Development of drugs --- New drug development --- Pharmacology --- Pharmacy --- Clinical drug trials --- Clinical trials of drugs --- Drug bioscreening --- Drug trials --- Clinical pharmacology --- Testing. --- Safety measures. --- Research --- Development --- Clinical trials --- Effectiveness --- Testing --- Evaluation

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FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label --

Drug approval --- Safety regulations --- United States. --- Approval of drugs --- Approval of new drugs --- Drug approval process --- New drug approval --- Pharmaceutical policy --- FDA --- F.D.A. --- U.S. Food & Drug Administration --- AB --- ABSh --- Ameerika Ühendriigid --- America (Republic) --- Amerika Birlăshmish Shtatlary --- Amerika Birlăşmi Ştatları --- Amerika Birlăşmiş Ştatları --- Amerika ka Kelenyalen Jamanaw --- Amerika Qūrama Shtattary --- Amerika Qŭshma Shtatlari --- Amerika Qushma Shtattary --- Amerika (Republic) --- Amerikai Egyesült Államok --- Amerikanʹ Veĭtʹsėndi͡avks Shtattn --- Amerikări Pĕrleshu̇llĕ Shtatsem --- Amerikas Forenede Stater --- Amerikayi Miatsʻyal Nahangner --- Ameriketako Estatu Batuak --- Amirika Carékat --- AQSh --- Ar. ha-B. --- Arhab --- Artsot ha-Berit --- Artzois Ha'bris --- Bí-kok --- Ē.P.A. --- EE.UU. --- Egyesült Államok --- ĒPA --- Estados Unidos --- Estados Unidos da América do Norte --- Estados Unidos de América --- Estaos Xuníos --- Estaos Xuníos d'América --- Estatos Unitos --- Estatos Unitos d'America --- Estats Units d'Amèrica --- Ètats-Unis d'Amèrica --- États-Unis d'Amérique --- Fareyniḳṭe Shṭaṭn --- Feriene Steaten --- Feriene Steaten fan Amearika --- Forente stater --- FS --- Hēnomenai Politeiai Amerikēs --- Hēnōmenes Politeies tēs Amerikēs --- Hiwsisayin Amerikayi Miatsʻeal Tērutʻiwnkʻ --- Istadus Unidus --- Jungtinės Amerikos valstybės --- Mei guo --- Mei-kuo --- Meiguo --- Mî-koet --- Miatsʻyal Nahangner --- Miguk --- Na Stàitean Aonaichte --- NSA --- S.U.A. --- SAD --- Saharat ʻAmērik --- SASht --- Severo-Amerikanskie Shtaty --- Severo-Amerikanskie Soedinennye Shtaty --- Si͡evero-Amerikanskīe Soedinennye Shtaty --- Sjedinjene Američke Države --- Soedinennye Shtaty Ameriki --- Soedinennye Shtaty Severnoĭ Ameriki --- Soedinennye Shtaty Si͡evernoĭ Ameriki --- Spojené obce severoamerick --- Spojené staty americk --- SShA --- Stadoù-Unanet Amerika --- Stáit Aontaithe Mheirice --- Stany Zjednoczone --- Stati Uniti --- Stati Uniti d'America --- Stâts Unîts --- Stâts Unîts di Americhe --- Steatyn Unnaneysit --- Steatyn Unnaneysit America --- SUA --- Sŭedineni amerikanski shtati --- Sŭedinenite shtati --- Tetã peteĩ reko Amérikagua --- U.S. --- U.S.A. --- United States of America --- Unol Daleithiau --- Unol Daleithiau America --- Unuiĝintaj Ŝtatoj de Ameriko --- US --- USA --- Usono --- Vaeinigte Staatn --- Vaeinigte Staatn vo Amerika --- Vereinigte Staaten --- Vereinigte Staaten von Amerika --- Verenigde State van Amerika --- Verenigde Staten --- VS --- VSA --- Wááshindoon Bikéyah Ałhidadiidzooígí --- Wilāyāt al-Muttaḥidah --- Wilāyāt al-Muttaḥidah al-Amirīkīyah --- Wilāyāt al-Muttaḥidah al-Amrīkīyah --- Yhdysvallat --- Yunaeted Stet --- Yunaeted Stet blong Amerika --- ZDA --- Združene države Amerike --- Zʹi͡ednani Derz͡havy Ameryky --- Zjadnośone staty Ameriki --- Zluchanyi͡a Shtaty Ameryki --- Zlucheni Derz͡havy --- ZSA --- ABŞ --- Amerikanʹ Veĭtʹsėndi͡avks Shtattnė --- É.-U. --- ÉU --- Saharat ʻAmērikā --- Spojené obce severoamerické --- Spojené staty americké --- Stáit Aontaithe Mheiriceá --- Wááshindoon Bikéyah Ałhidadiidzooígíí