This blue-chip guide adds quality to the pharmaceutical clinical development process by detailing the need for, and stressing the importance of, an independent audit of clinical data to protect participants and validate study results. Examines the use of personal computers, the Internet, and third-party organizations to assist in data validation! Positioning the audit as the only reliable tool to verify that a drug has been shown to be safe and effective in clinical trials, The Clinical Audit in Pharmaceutical Development
recommends establishing auditing and quality assurance at the beginning of a clinical study
describes Good Clinical Practices (GCPs) and the role of regulatory agencies in the review, validation, and auditing processes
outlines the clinical process, from trial design through report writing
compares and contrasts United States and international regulatory statutes
identifies monitoring as the key to guaranteeing high-quality data
focuses on the role of the clinical audit in achieving unity in a multinational study
discusses the worldwide influence of the US Food and Drug Administration audit
analyzes findings from previous FDA clinical audits to reveal trends and future directions
provides guidelines for fraud detection and considers the ramifications of falsified data
and more! Confirming that all clinical information has been properly collected and reported, The Clinical Audit in Pharmaceutical Development is a crucial reference for clinical and research pharmacists and pharmacologists; biostatisticians; clinical research associates, coordinators, and investigators; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.
This blue-chip guide adds quality to the pharmaceutical clinical development process by detailing the need for, and stressing the importance of, an independent audit of clinical data to protect participants and validate study results. Examines the use of personal computers, the Internet, and third-party organizations to assist in data validation! Positioning the audit as the only reliable tool to verify that a drug has been shown to be safe and effective in clinical trials, The Clinical Audit in Pharmaceutical Development
recommends establishing auditing and quality assurance at the beginning of a clinical study
describes Good Clinical Practices (GCPs) and the role of regulatory agencies in the review, validation, and auditing processes
outlines the clinical process, from trial design through report writing
compares and contrasts United States and international regulatory statutes
identifies monitoring as the key to guaranteeing high-quality data
focuses on the role of the clinical audit in achieving unity in a multinational study
discusses the worldwide influence of the US Food and Drug Administration audit
analyzes findings from previous FDA clinical audits to reveal trends and future directions
provides guidelines for fraud detection and considers the ramifications of falsified data
and more! Confirming that all clinical information has been properly collected and reported, The Clinical Audit in Pharmaceutical Development is a crucial reference for clinical and research pharmacists and pharmacologists; biostatisticians; clinical research associates, coordinators, and investigators; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.
In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early...
This user-friendly volume presents a basic knowledge on how to perform an audit or inspect a facility and meets all the needs of the audience. It is a key reference source for those training as...
Pharmaceutical and clinical calculations are critical to the delivery of safe, effective, and competent patient care and professional practice. Pharmaceutical and Clinical Calculations, Second...
Discover your next great read at BookLoop, Australiand online bookstore offering a vast selection of titles across various genres and interests. Whether you're curious about what's trending or searching for graphic novels that captivate, thrilling crime and mystery fiction, or exhilarating action and adventure stories, our curated collections have something for every reader. Delve into imaginative fantasy worlds or explore the realms of science fiction that challenge the boundaries of reality. Fans of contemporary narratives will find compelling stories in our contemporary fiction section. Embark on epic journeys with our fantasy and science fiction titles,
Shop Trending Books and New Releases
Explore our new releases for the most recent additions in romance books, fantasy books, graphic novels, crime and mystery books, science fiction books as well as biographies, cookbooks, self help books, tarot cards, fortunetelling and much more. With titles covering current trends, booktok and bookstagram recommendations, and emerging authors, BookLoop remains your go-to local australian bookstore for buying books online across all book genres.
Shop Best Books By Collection
Stay updated with the literary world by browsing our trending books, featuring the latest bestsellers and critically acclaimed works. Explore titles from popular brands like Minecraft, Pokemon, Star Wars, Bluey, Lonely Planet, ABIA award winners, Peppa Pig, and our specialised collection of ADHD books. At BookLoop, we are committed to providing a diverse and enriching reading experience for all.
Sign In
your cart
Your cart is empty
Menu
Search
PRE-SALES
If you have any questions before making a purchase chat with our online operators to get more information.
