Systematic Optimization, In Vitro Drug Release, and Preliminary Nonclinical Toxicity Assessment of Nonphospholipid-Based Topical Ophthalmic Emulsions Containing 0.05 or 0.1% w/w Cyclosporin A for Dry-Eye Syndrome Management

Author:

Rahman Syed Nazrin Ruhina,Pawde Datta Maroti,Katari Oly,Hmingthansanga Victor,Shunmugaperumal TamilvananORCID

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Reference25 articles.

1. . Q8(R2) pharmaceutical development. Part I: pharmaceutical development, and Part II: annex to pharmaceutical development. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf (2009). Accessed date 1 Aug 2019.

2. ICH. Q9 quality risk management. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf (2005). Accessed date1 Aug 2019.

3. ICH. Q10 pharmaceutical quality system. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf (2008). Accessed date 1 Aug 2019.

4. Pflugfelder SC. Antiinflammatory therapy for dry eye. Am J Ophthalmol. 2004;137:337–42.

5. Fruman DA, Klee CB, Bierer BE, Burakoff SJ. Calcineurin phosphatase activity in T lymphocytes is inhibited by FK 506 and cyclosporin A. Proc Natl Acad Sci U S A. 1992;89:3686–90.

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