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The Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)
The drug pipeline is also sometimes restricted to a particular drug class or extended to mean the process of discovering drugs (the research and development pipeline). [3] The R&D pipeline involves various phases that can broadly be grouped in 4 stages: discovery, pre-clinical, clinical trials and marketing (or post-approval).
Drug Development and Industrial Pharmacy is an academic journal that publishes research on aspects of drug development and production, as well as the evaluation of drugs and pharmaceutical products. Core areas
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
Pharmaceutical Development and Technology is a peer-reviewed pharmaceutical journal that is published by Taylor & Francis. It covers research on the design, development, manufacture, and evaluation of conventional and novel drug delivery systems , emphasizing practical solutions and applications to theoretical and research-based problems.
In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.
PPD was founded by Fred Eshelman, Pharm.D., as a one-person consulting firm in 1985. The following year, he expanded the company's scope to include development services and relocated operations from Maryland to North Carolina. July 1985: Fred Eshelman, Pharm.D., founds PPD as a one-person consulting firm based in his home in Maryland.