Review of New Medications

Review of New Medications
Student’s Name
Institutional Affiliation
Abstract
The Food and Drug Administration, through the Centre for Drug Evaluation and Research, has always made efforts to ensure the safety and effectiveness of drugs brought into the United States’ market. However, CDER is not liable for testing drugs but has the Office of Testing and Research conducting significant research focusing on drug quality, safety, and effectiveness (FDA, 2015). Resolutely, for a drug to receive approval from the FDA and CDER, the researchers and organizations involved in its development and production have to provide credible and comprehensive results alluding to the six factors that CDER considers essential, for example, performance of drug review, risk assessment, and relative tests that highlight the safety and effectiveness. Resolutely, this paper is comprehensive research on Rituximab (also known as Rituxan or Mabthera) and Humira (also known as Adalimumab). The primary factor of focus is the development of these drugs with the information being presented in the FDA chart.
Review of New Medications
Rituximab, also known as Rituxan or Mabthera, and Humira, also known as Adalimumab, are popular drugs as indicated by their prevalence through different advertisements and dominance as two of the best-selling drug products today.
Rituximab (Rituxan/Mabthera)
Phase Purpose Subjects
(How many and how selected) Type(s) of Study Design Used
Phase I The first studies in animals and humans
 
 
 
  One subject
Selection Criteria: A patient with Non-Hodgkin Lymphoma (NHL) The study was in the form of a treatment where researchers attempted to treat a patient with Non-Hodgkin Lymphoma (NHL) (NCI, 2014)
Phase II To determine dosage, pharmaco-dynamics, short-term safety, effects
 
 
 
  N/A
Selection Criteria: Patients with Non-Hodgkin Lymphoma (NHL) It contained monoclonal antibodies that would utilize the body’s immune system to destroy cancer cells
Treatment using Rituximab would bind the antibodies to CD20 (a protein found on both healthy and cancerous B cells) to eliminate the cancerous B cells (NCI, 2014)
Phase III To provide much of the information on which licensure is based.

 
 
 
   N/A
Selection Criteria: Patients with Non-Hodgkin Lymphoma (NHL) Treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-Hodgkins Lymphoma
An evaluation study on the time and temperature specification for transport of Rituximab Formulated Bulk
Environmental monitoring survey (NCI, 2014)
Phase IV Studies in large populations conducted during the first few years post-licensure.
 
 
 
   N/A
Selection Criteria: Patients with Non-Hodgkin Lymphoma (NHL) Combination of Rituximab and traditional chemotherapy for prolonged survival for NHL patients
Phase V Long-Term follow-up of licensed agents.
 
 
 
   
Selection Criteria: Patients with breast and gastric cancer, melanoma, and colon cancer (NCI, 2014)  Monoclonal antibody treatments, that is, trastzumab, ipilimumab, and bevacizumab
Humira (Adalimumab)
Phase Purpose Subjects
(How many and how selected) Type(s) of Study Design Used
Phase I The first studies in animals and humans
 
 
 
  Rat subjects Use of experimental systems to prevent polyarthritis using a rat model that mimicked the clinical and histopathological progression of human rheumatoid arthritis
Phase II To determine dosage, pharmaco-dynamics, short-term safety, effects
 
 
 
  Selection Criteria: Patients with moderate to severe RA Combination of adalimumab and methotrexate (MTX) for the treatment of patients with moderate to severe RA (Azevedo et al., 2016)
Phase III To provide much of the information on which licensure is based.
 
 
 
  3000 subjects
Selection Criteria: Patients with RA older than 18 years (Azevedo et al., 2016) Efficacy and safety assessment of adalimumab
Phase IV Studies in large populations conducted during the first few years post-licensure.
 
 
 
  271 subjects
Selection Criteria: Patients with moderate to severe RA Clinical trial where the patients were given 20mg, 40mg, and 80mg doses of adalimumab (Azevedo et al., 2016)
Phase V Long-Term follow-up of licensed agents.
 
 
 
  54 subjects
Selection Criteria: Volunteers with RA (Azevedo et al., 2016) Adalimumab monotherapy meant to investigate the efficacy of this type of treatment
References
National Cancer Institute (NCI). (2014). Using the Immune System in the Fight against Cancer: Discovery of Rituximab. Retrieved from https://www.cancer.gov/research/progress/discovery/blood-cancerAzevedo, V. F., Troiano, L. D. C., Galli, N. B., Kleinfelder, A., Catolino, N. M., & Martins, P. C. U. (2016). Adalimumab: a review of the reference product and biosimilars. Biosimilars, 2016(1), 29-44.
US Food and Drug Administration (FDA). (2015). How Drugs are Developed and Approved. US Department of Health and Human Services. Retrieved from https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm