Development & Approval Process (Drugs) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm Guidance Documents for Drug Applications http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm090361.htm Laws, Regulations, Policies and Procedures for Drug Applications http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm090410.htm How Drugs are Developed and Approved http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm Conducting Clinical Trials http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ConductingClinicalTrials/default.htm Forms & Submission Requirements http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/default.htm Electronic Regulatory Review http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm085358.htm Electronic Regulatory Submissions http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm085324.htm Electronic Regulatory Submissions and Review Helpful Links http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm085361.htm Supporting CDISC […]
At this link Clinical Trial Listings by Medical Areas – You can get the latest clinical trials going on at different places….Here you can gather the Trial Information such as ” A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability and ” blah…..blah…. and inclusion and exclusion criteria…..An Excellent source of Functional Information on a Company’s drug.
The drug development process is a clinical process that has its own language. It is not required that SAS programmers function as a MD or a regulatory expert, but working knowledge of the terminology is important to be effective. This paper will walk through the drug development process from discovery to Phase IV. It will explain a wide range of acronyms such as IND, NDA, GCP and MedDRA. It will also describe some of the terminologies used within the process of clinical trials as a drug is developed and submitted to the FDA. This will give SAS programmers a larger perspective and context to their work during the analysis and reporting of clinical trials data.
New chemical entities (NCEs) are discovered through screening existing compounds or designing new molecules. Once synthesized, they go through a rigorous testing process. Their pharmacological activity, therapeutic promise, and toxicity are tested using isolated cell cultures and animals, as well as computer models. A promising NCE is then modified to optimize its pharmacological activity with fewer undesirable biological properties.
Once pre-clinical studies are completed and the NCE has been proven safe on animals, the drug sponsor applies for Investigational New Drug (IND) status. If it receives approval, Phase I clinical trials are started to establish the tolerance of healthy human subjects at different doses and to study the effects on humans of anticipated dosage levels. The firm also studies the NCE’s absorption, distribution, metabolism, and excretion patterns. This stage requires careful supervision, as it is not yet certain if the drug is safe for humans. Phase 1 primarily determines how a medicine works in humans and helps to predict the dosage range for the medicine, and involves healthy volunteers. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study.