Diaa Shakleya
Senior Pharmacologist & Principal Investigator at U.S. Food and Drug Administration, Silver Spring, Maryland.
- Role
- Principal Investigator, Biopharmaceutics and Drug Delivery System Programs at FDA
- Location
- Germantown, MD, US
- LinkedIn followers
- 500 followers
Experience
Principal Investigator, Biopharmaceutics and Drug Delivery System Programs
Oct 2014 — Present · Silver Spring, MD, US
My current position will be integrated within the Division of Product Quality Research (DPQR), Office of Testing and Research-OPS/CDER, which is responsible for strengthening the scientific foundation of regulatory policies that define the quality of dtug products during the pre and post approval process. I will also serve as a pharmacologist expert in the fields of pharmacology, pharmaceutical sciences and is proficient in the performance of a variety of methods and techniques that represent the modern scientific technology that is applied to the solution of the problems associated with the tasks and goals of the division.I will guide and collaborate with scientists and engage in developing advanced techniques designed to ensure drug quality, safety and efficacy; provide expert guidance and assistance to analysts and scientists from regulated industries on matters related to bioavailability and bioequivalence issues.
Education
University of Mumbai
Ph.D
1999 — 2002
West Virginia University
Postdcotoral Fellow
2003 — 2004
Skills
- Hplc
- Drug Discovery
- Biotechnology
- Molecular Biology
- In Vitro
- Analytical Chemistry
- Chemistry
- Protein Chemistry
- Drug Delivery
- Pharmacology
- Toxicology
- Pharmaceutical Research
- Purification
- Nmr
- Chromatography
- Gmp
- Clinical Development
- Validation
- Drug Metabolism
- Method Development
- Cell Culture
- Assay Development
- Sds-Page
- In Vivo
- Biopharmaceuticals
- Lc-Ms
- Dna
- Bioanalysis
- Pharmacokinetics
- Formulation
- Lifesciences
- Uv/Vis
- Mass Spectrometry
- Drug Development
- Laboratory
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