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Drug development and discovery


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Drug development and discovery

  2. 2. OBJECTIVES Learn the processes involved in drug discovery and development Define the phases involved in FDA drug approval be aware of why/how new drugs are discovered know the processes involved in drug discovery and development see where pharmacologists/bioscientists may contribute know about the difficulties and dangers inherent in the drug development process. WOLYITA UNIVERSITY DEPT. OF PHARMACY
  3. 3. A substance used in the diagnosis, treatment, or prevention of a disease or as a component of a medication recognized or defined by the U.S. Food, Drug, and Cosmetic Act. A drug is any chemical or biological substance, synthetic or non-synthetic that can alter the structure and function of an organism. 09/07/2007 DEPT. OF PHARMACEUTICS 3 drug Introduction
  4. 4. The discovery and development of new medicines is along, complicated process. Each success is built on many, many prior failures. Advances in understanding human biology and disease are opening up exciting new possibilities for break through medicines. At the same time, researchers face great challenges in understanding and applying These advances to the treatment of disease. These possibilities will grow as our scientific knowledge expands and becomes increasingly complex. Research- based pharmaceutical companies are committed to advancing science and bringing in new medicines to patients
  5. 5. THE CHANGED CONTEXT OF DRUG DISCOVERY AND DEVELOPMENT The 1800s: natural sources; limited possibilities; prepared by individuals; small scale; not purified, standardized or tested; limited administration; no controls; no idea of mechanisms. The 1990s: synthetic source; unlimited possibilities; prepared by companies; massive scale; highly purified, standardized and tested; world-wide administration; tight legislative control; mechanisms partly understood.
  6. 6. SOURCES OF DRUGS Animal insulin (pig, cow) growth hormone (man) Plant digitalis (digitalis purpurea - foxglove) morphine (papaver somniferum) Inorganic arsenic mercury lithium Synthetic chemical (propranolol) biological (penicillin) biotechnology (human insulin)
  7. 7. DRUG DISCOVERY/DEVELOPME NT PROCESS discovery; refinement; chemical & biological characterisation safety & toxicity in animals; formulation development volunteer studies; patient studies regulatory process marketing post registration monitoring lessons & development Discovery=find new active structure : Development=convert it to a useful drug
  8. 8. RESEARCH AND DEVELOPMENT PROCESS (R&D) Development of new drugs is a complex and costly process It takes an average of 12 years and about $350 million to get a new drug from the laboratory to the pharmacy shelf R&D involves discovery (preclinical studies) and development (clinical studies) Only one in 1000 compounds which begin laboratory testing will make it to human testing
  9. 9. ROLE OF FDA The Food and Drug Administration (FDA) is required to review and approve all new drugs in the United States The FDA reviews and evaluates new drugs based on the evidence presented from the clinical research studies performed by the drug sponsor-typically a pharmaceutical company
  10. 10. PRECLINICAL STUDIES Synthesis and purification of the new drug Pharmacology of the new drug:  Pharmacokinetics: absorption, distribution, metabolism, excretion, half-life  Pharmacodynamics: mechanism of action and estimates of therapeutic effects  Toxicology including carcinogenicity, mutagenicity, and teratogenicity Efficacy studies on animals
  11. 11. IND Investigational New Drug (IND): Application for permission to administer a new drug to humans Outlines the proposal to use the new drug for human testing in clinical trials Studies in humans can only begin after IND is reviewed and approved by the FDA and an institutional review board (IRB)
  12. 12. CLINICAL STUDIES Phase 1: Efficacy studies on healthy volunteers Phase 2: Clinical studies on a limited scale Phase 3: Comparative studies on large number of patients Phase 4: Continued comparative studies. Registration and market introduction
  13. 13. PHASE 1 Typically involves 20-80 healthy volunteers (no women of childbearing potential) Emphasis is on drug safety Goal is to identify major side effects, metabolism and routes of excretion Lasts about 1 year About 70% of drugs will pass this phase
  14. 14. PHASE 2 Typically involves 100-300 individuals who have the target disease Emphasis is on effectiveness Patients receiving the drug are compared to similar patients receiving a placebo or another drug Lasts about 2 years About 33% of drugs will pass this phase
  15. 15. PHASE 3 Typically involves 1000-3000 patients Emphasis is on safety and effectiveness Investigates through well-controlled studies different populations and different dosages as well as uses new drug in combination with other drugs Lasts about 3 years 25-30% of drugs will pass this phase
  16. 16. NDA Pre-NDA period: FDA and drug sponsors meet Submission of NDA: Formal step asking the FDA to consider approving a drug for marketing FDA has 60 days to decide whether it will file it for approval consideration If filed, a review team is assigned to evaluate the new drug
  17. 17. FDA ROLE The review team evaluates the research on the safety of the drug and its effectiveness The FDA reviews the information to go on the drug label It inspects the facilities where the drug will be manufactured The application will be classified as “approvable” or “not approvable”
  18. 18. FDA ROLE If approvable, the FDA requests additional information from the sponsor The NDA is again reviewed Following drug approval, sponsors of the drug will be required to continually assess the safety of the drug
  19. 19. PHASE 4 Post-market surveillance of the drug to continually assess the safety of the drug May include incidence and severity of rare adverse reactions, cost-effectiveness analyses, comparative trials, and quality of life studies
  21. 21. 22 QUESTIONS?