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Beskrivelse
Drug Discovery, Preclinical, and Clinical Drug Development Volume 1: This is an exceptional book that touches on all aspects of Pharmaceutical and Clinical Research inclusive of drug discovery and preclinical drug development. This book is an all-rounder that covers the scope of the development of medicine and drug research from scratch to finish. This book teaches you all you need to know about drug discovery, the history of drug discovery, preclinical research development, regulatory science, ethics in medicine, and clinical research. This book is exceptional in that it touches on all aspects of drug development with scenario live examples and exercises to help the reader learn how drugs are discovered, screened, synthesized, formulated, pre-clinical, regulatory submission and GCP 2024, Clinical trial preparations, Clinical trial regulatory submission and applications, ethics in clinical research, clinical research design, pharmaceutical medicine, patent laws, and application, etc.
This book is a masterpiece for those trying to enter into clinical research and those professionals like clinical research associates, clinical research physicians, clinical research nurses, clinical research students, clinical research coordinators, and clinical trial assistants who might want to have both the theoretical and practical knowledge of clinical research, drug discovery, and development. The book is tagged as an all-rounder in that you got to learn both the background basics and advanced level topics that will increase and broaden your horizon and knowledge in clinical research with a deep understanding of practical aspects of clinical research, preclinical studies, and overall drug discovery/drug development.
Those new in the industry about to enter or already old in the industry will find this book practically oriented with a deep understanding of the theoretical aspect of clinical research and development. Some of the topics covered in this are drug discovery, pre-clinical drug development, clinical drug development, medical device trials, ICH-GCP R3 2024 Expectation, Common Technical Document, pharmaceutical medicine, combinatorial chemistry, medicinal chemistry, history of the 21st-century regulatory application and submission guideline 2024, clinical trials and different phases of clinical trials, types of monitoring clinical research and how to monitor clinical research, etc.
This is a must-read book that covers all aspects of drug development and clinical drug development from scratch to finish with practical scenario examples, questions and answers, and practice exercises.
In this book, you are going to learn the following topics,The History of Drug Discovery, Preclinical Drug Development and Clinical Drug Development.Regulatory Affairs / Ethics in Clinical ResearchThe Role of Regulatory Affairs ProfessionalsUS Food and Drug AdministrationHistory of 21st-century regulatory/ethicalMedical Device TrialsCommon Technical DocumentsICH-GCP R3 2024 ExpectationIND applications, methods, and submissionDifferent phases of clinical trialsClinical Research monitoring and types of monitoring.How to design a protocol, case report forms, and recruitment formsHow to design clinical researchPharmaceutical MedicinePatenting laws, application, and submission.Clinical Drug Development.
