New Drug Development . Compound centered. Target centered. Compound centered approach. Natural products: isolated from plants, animals and microorganisms. Morphine, Quinine, Atropine. Adrenaline, Thyroxine.
Penicillin Natural ligands : Natural ligands Examples. Dopamine- Parkinson- L- dopa. Insulin . Histamine blockers. Based on enantiomers - ex. Proton Pump Inhibitors. COX 2 inhibitors.
Combinatorial chemistry. Growth factors, cytokines. Their job is to ensure that the risks of being in the study are not greater than the potential benefit.
HIV perinatal transmission. AZT. Various cancer treatments. Development of other HIV related medications like PIs NY/VI AETC The Impact of Clinical Trials- Unsuccessful : The Impact of Clinical Trials- Unsuccessful Medications did not work as in pre clinical study.
Loss of Follow- Up. Harmful substance. Unethical & poorly conducted study (Ex: Gene Replacement Study) NY/VI AETC APPROVAL : APPROVAL Once all clinical data has been submitted, reviewed and approval is granted to license in market. Post marketing surveillance. Approval takes 6 months to 2 years Slide 4.
- Course Agenda First Day Drug Development and Project Management Overview of the Drug Development Process The History of Project Management Overview of Clinical Phases – What are they? Phase 0 or Exploratory INDs Phase 1 Phase 2 (a/b) Phase 3 (a/b).
- New Drug Development Process At one time or another everyone has relied on prescription drugs to help treat or cure a symptom or illness. In fact, approximately 2 billion prescriptions are filled each year in the United States, but few know of the.
- Drug Discovery and Drug Development I. RATIONALE The infectious disease burden inflicted by tropical diseases continues to exact a huge price both in human.
- Of clinical research and drug development, coupled with the critical issue of time to market, can capitalize on project management techniques to effectively apply scheduling, risk management, and comprehensive quality assurance and control to.
- Drug Development Projects are not grant funding awards. Approved projects are sponsored, funded and managed by our Centre for Drug Development (CDD), and a project team is allocated to work in partnership with you. The CDD fund and manage the project for as.
Project Plan Template Updated; Helps Facilitate Interdepartment Function and Communication. Eriban Research (Kansas City, MO) released the 2007 version of its comprehensive drug development template. The new version incorporates over 8300 tasks. Overview of Drug Development Namrata Bahadur Head of Clinical Development & Medical Affairs Emerging Growth Markets 17th –21st March, Bangkok. Project Management plan Version <1.0> <mm/dd/yyyy> VERSION HISTORY . Use the table below to provide the version number, the author.