Drug, Discovery and Development Article

Drug, Discovery and Development Article - Phase 3 Large...

Info icon This preview shows page 1. Sign up to view the full content.

View Full Document Right Arrow Icon
Drug Process 3 to 6 Years 5000 6 to 7 years 2 years 10000 Pre-Discovery -> Drug Discovery -> Preclinical -> Clinical Trials (Phase 1,2,3) -> NDA -> FDA Review -> MFG -> Phase 4 (Optional, Post Market Surveillance) -FDA must approve clinical trials -Patent submission is usually started before pre-clinical trials, patent last 20 years from submission, but the patent will probably only protect the drug for 9-12 years while it is sold due to R&D length Hatch Waxman Act - Governs what happens at the end of a patent Development First Part of Development - What is wrong with the body? 2 nd - Target it 3 rd - Deliver a chemical or molecule to fix the thing that went wrong Active Ingredients- Naturally occurring substances, chemically constructed small molecule, biologics/large molecules (essentially live organism) Clinical Trials Phase 1- Healthy volunteers Phase 2- Small group of patients
Image of page 1
This is the end of the preview. Sign up to access the rest of the document.

Unformatted text preview: Phase 3- Large group of patients 3 Factors to do these trials- Placebo Trial, Double-Blind, Completely Randomized-It is more expensive to conduct clinical trials where you cannot use a placebo (if there’s already a cure/medication for what you’re trying to fix)-If during a trial it is clear that a drug is working, you have to stop the placebo trials and give them the actual drug-Black Box warning, reserved for serious side effects You cannot sell a drug until the FDA says it is safe and effective, and they will not do this without these clinical trials Phase 4 Trial- Additional, loads of data from millions using it CEO of Lilly-There is a war on innovation; drug companies won’t innovate without profits, denying patents denies profits-If we push to hard on the access we will eliminate incentives to create new drugs for other conditions...
View Full Document

{[ snackBarMessage ]}

What students are saying

  • Left Quote Icon

    As a current student on this bumpy collegiate pathway, I stumbled upon Course Hero, where I can find study resources for nearly all my courses, get online help from tutors 24/7, and even share my old projects, papers, and lecture notes with other students.

    Student Picture

    Kiran Temple University Fox School of Business ‘17, Course Hero Intern

  • Left Quote Icon

    I cannot even describe how much Course Hero helped me this summer. It’s truly become something I can always rely on and help me. In the end, I was not only able to survive summer classes, but I was able to thrive thanks to Course Hero.

    Student Picture

    Dana University of Pennsylvania ‘17, Course Hero Intern

  • Left Quote Icon

    The ability to access any university’s resources through Course Hero proved invaluable in my case. I was behind on Tulane coursework and actually used UCLA’s materials to help me move forward and get everything together on time.

    Student Picture

    Jill Tulane University ‘16, Course Hero Intern