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MeSH Review

Drug Approval

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Disease relevance of Drug Approval


High impact information on Drug Approval


Biological context of Drug Approval


Associations of Drug Approval with chemical compounds


Gene context of Drug Approval

  • The OTC drug monograph process and the NDA route of OTC drug approval are two different methods that reach the same result, the approval of safe and effective drugs [8].
  • Postmarketing surveillance: curriculum for the clinical pharmacologist. Part I: Postmarketing surveillance within the continuum of the drug approval process [14].
  • Drug approval often depends on a 75% improvement in the baseline PASI score, also known as a PASI 75 or Delta PASI 75 [15].
  • Based on mechanistic approaches to the drug absorption and dissolution processes, the BCS enables the regulatory bodies to simplify and improve the drug approval process [16].
  • Surrogate markers, such as CD4 counts and viral RNA levels, have been used recently in the anti-human immunodeficiency virus drug approval process with success [17].

Analytical, diagnostic and therapeutic context of Drug Approval


  1. Food and Drug Administration Drug approval summary: temozolomide plus radiation therapy for the treatment of newly diagnosed glioblastoma multiforme. Cohen, M.H., Johnson, J.R., Pazdur, R. Clin. Cancer Res. (2005) [Pubmed]
  2. FDA drug approval summary: pemetrexed for injection (Alimta) for the treatment of non-small cell lung cancer. Cohen, M.H., Johnson, J.R., Wang, Y.C., Sridhara, R., Pazdur, R. Oncologist (2005) [Pubmed]
  3. The TPA controversy and the drug approval process. The view of the Cardiovascular and Renal Drugs Advisory Committee. Kowey, P.R., Fisher, L., Giardina, E.G., Leier, C.V., Lowenthal, D.T., Messerli, F.H., Pratt, C.M. JAMA (1988) [Pubmed]
  4. Mitoxantrone and the new drug approval process. Abeloff, M.D. J. Clin. Oncol. (1989) [Pubmed]
  5. U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval. Cohen, M.H., Johnson, J.R., Pazdur, R. Clin. Cancer Res. (2005) [Pubmed]
  6. United States Food and Drug Administration Drug Approval summary: Gefitinib (ZD1839; Iressa) tablets. Cohen, M.H., Williams, G.A., Sridhara, R., Chen, G., McGuinn, W.D., Morse, D., Abraham, S., Rahman, A., Liang, C., Lostritto, R., Baird, A., Pazdur, R. Clin. Cancer Res. (2004) [Pubmed]
  7. Zalcitabine. Clinical pharmacokinetics and efficacy. Devineni, D., Gallo, J.M. Clinical pharmacokinetics. (1995) [Pubmed]
  8. The OTC drug approval process. The ACG Committee on FDA-Related Matters. American College of Gastroenterology. Fredd, S.B. Am. J. Gastroenterol. (1990) [Pubmed]
  9. Impact of the Food and Drug Administration approval of flecainide and encainide on coronary artery disease mortality: putting "Deadly Medicine" to the test. Anderson, J.L., Pratt, C.M., Waldo, A.L., Karagounis, L.A. Am. J. Cardiol. (1997) [Pubmed]
  10. Development and validation of a gas chromatography/mass spectrometry procedure for confirmation of para-toluenesulfonamide in edible fish fillet tissue. Idowu, O.R., Kijak, P.J., Meinertz, J.R., Schmidt, L.J. Journal of AOAC International. (2004) [Pubmed]
  11. The liposomal formulation of doxorubicin. Abraham, S.A., Waterhouse, D.N., Mayer, L.D., Cullis, P.R., Madden, T.D., Bally, M.B. Meth. Enzymol. (2005) [Pubmed]
  12. FDA drug approval summaries: pemetrexed (Alimta). Hazarika, M., White, R.M., Johnson, J.R., Pazdur, R. Oncologist (2004) [Pubmed]
  13. U.S. Food and Drug Administration drug approval summaries: imatinib mesylate, mesna tablets, and zoledronic acid. Cohen, M.H., Dagher, R., Griebel, D.J., Ibrahim, A., Martin, A., Scher, N.S., Sokol, G.H., Williams, G.A., Pazdur, R. Oncologist (2002) [Pubmed]
  14. Postmarketing surveillance: curriculum for the clinical pharmacologist. Part I: Postmarketing surveillance within the continuum of the drug approval process. Johnson, J., Tanner, L.A. Journal of clinical pharmacology. (1993) [Pubmed]
  15. Rethinking the Psoriasis Area and Severity Index: the impact of area should be increased. Jacobson, C.C., Kimball, A.B. Br. J. Dermatol. (2004) [Pubmed]
  16. Modern bioavailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards. Löbenberg, R., Amidon, G.L. European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V. (2000) [Pubmed]
  17. Use of surrogate markers for drugs of military importance. Marino, M.T. Military medicine. (1998) [Pubmed]
  18. FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension. Kaminskas, E., Farrell, A.T., Wang, Y.C., Sridhara, R., Pazdur, R. Oncologist (2005) [Pubmed]
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