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Book
Innovation in clinical trial methodologies
Author:
ISBN: 0323860060 0128244909 9780128244906 9780323860062 Year: 2021 Publisher: Amsterdam

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Abstract

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.

Keywords

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


Periodical
Center for Drug Evaluation and Research update.
Author:
ISSN: 21502390 Year: 2007 Publisher: [Silver Spring, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Abstract

Keywords

Drugs --- Pharmaceutical policy --- Drug approval --- Drug approval. --- Pharmaceutical policy. --- Drug Approval --- Drug Industry --- Testing --- Testing. --- Center for Drug Evaluation and Research (U.S.) --- United States. --- United States --- Industries, Pharmaceutic --- Industry, Drug --- Industry, Pharmaceutic --- Industry, Pharmaceutical --- Pharmaceutical Industry --- Drug Industries --- Industries, Drug --- Industries, Pharmaceutical --- Pharmaceutic Industries --- Pharmaceutic Industry --- Pharmaceutical Industries --- 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 --- Drug policy --- Drugs and state --- Pharmacy and state --- Pharmacy --- State and drugs --- State and pharmacy --- Medical policy --- Clinical drug trials --- Clinical trials of drugs --- Drug bioscreening --- Drug trials --- Clinical pharmacology --- Drug development --- Approval of drugs --- Approval of new drugs --- Drug approval process --- New drug approval --- Medicaments --- Medications --- Medicine (Drugs) --- Medicines (Drugs) --- Pharmaceuticals --- Prescription drugs --- Bioactive compounds --- Medical supplies --- Pharmacopoeias --- Chemotherapy --- Materia medica --- Pharmacology --- Government policy --- Clinical trials --- Effectiveness --- Evaluation --- C.D.E.R. --- CDER --- Center for Drugs and Biologics (U.S.) --- ABŞ --- 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 Shtattnė --- 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. --- É.-U. --- 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 --- ÉU --- 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 ʻAmērikā --- 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 severoamerické --- Spojené staty americké --- SShA --- Stadoù-Unanet Amerika --- Stáit Aontaithe Mheiriceá --- 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 Ałhidadiidzooígíí --- 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

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