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Bronchofree

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by

Anjali Patel

on 15 October 2014

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Transcript of Bronchofree

Informed Consent for Medication
Common side effects:
sore throat, joint pain or irregular heartbeat
Less common side effects
: Fatigue, acid of sour stomach and dizziness
Caution:
Narrow-angle glaucoma, liver disease or diabetes
Warning:
Liver disease, asthma or paradoxical bronco spams
Clinical Trials (Cont.)
File an IND
Reviews preclinical testing and plans
Phase 3
Phase 2
Therapeutic index: 4.25

Pharmacodynamics: Cardio Electrophysiology

Mechanism of Action: Anticholinergic/analgesic; effects through inhibition of M3 receptor and inhibition of acetaminophen

Safe Dose Range: 225-325 mg
By: Selma Abdurrahman, Steven Duong, Sarai Doria, and Anjali Patel
Phase 1
Clinical Trials
Incruse Ellipta. (2000). Retrieved September 26, 2014, from Drugs.com website:
http://www.drugs.com/incruse-ellipta.html

Incruse Ellipta (umeclidinium inhalation powder). (n.d.). Retrieved from http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/1323/incruse-ellipta-umeclidinium-inhalation-powder

Drugs. (n.d.). Retrieved from http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm

Kelleher. (n.d.). Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: A randomized crossover trial. Retrieved October 8, 2014, from http://www.ncbi.nlm.nih.gov/pubmed/23284643

A Pharmacologic Overview of Tylenol® (acetaminophen). (n.d.). Retrieved October 8, 2014, from http://www.tylenolprofessional.com/pharmacology.html
Bibliography
Bronchofree
During this phase, we tested 250 volunteers diagnosed with COPD.
Our objective is to determine side effects, the mechanism of action, and the dose strength and schedules for using Bronchofree.
Clinial Trials (Cont.)
Absorbtion
5-10 minutes
Bioavailability: 95%
Lungs to blood
Distribution
Bound to plasma proteins
Transported to muscarinic
receptors and COX-3 enzyme
Biotransformation
Metabolized in the liver by:
conjugation with glucutonide
conjugation with sulfate
oxidation via the cytochrome
Excretion
2.5-4 hours
Through urine
Half-Life
3 hours
We tested our drug, Bronchofree, on 75 healthy volunteers. Our purpose is to determine whether our drug is safe. We tested a variety of doses from 100-500 mg. After the trial was done, we were able to determine the pharmacokinetics of Bronchofree.
Absorption
5-10 minutes
Bioavailability: 70%
Lungs to blood
Distribution
Bound to plasma proteins
Transported to muscarinic receptors and Cox-3 enzymes
Biotransformation
Metabolized in the liver by:
conjugation with glucutonide
conjugation with sulfate
oxidation via the cytochrome
Excretion
2.5-3.5 hours
through urine
Half-Life
3 hours
The purpose of clinical trials is so that the studies may follow strict scientific standards. These standards actually end up protecting patients and they help in producing reliable study results.
Safe Dose Range
Adverse or Toxic
Minimal Effect
Therapeutic Index: 4.25

Safe Dosage:
275 mg

4,000 People

During this phase, the Bronchofree inhaler will be approved by the FDA.
Researchers will make sure that it is safe for use.
We will also make sure that there are no final adverse effects.
Full transcript