IPS Technologies Tours at INTERPHEX 2014, February 2014
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Sam Halaby, Russ Somma, PhD, Mike Vileikis, Pharmaceutical Processing, Volume 29, Number 1, January/February 2014
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Pharmaceutical Processing, IPS Technologies Tours Supplement, April 2013
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Pharmaceutical Processing, March 2012, INTERPHEX 2012 Supplement
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Contract Pharma, October 2008
THE PHARMACEUTICAL INDUSTRY is buzzing about Quality by Design (QbD). To date, most contract manufacturers have stayed out of the discussion, assuming that the phrase has little to do with their role.
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PharmAsia news, January 2008
Wyeth has acquired global rights to Mochida Pharmaceutical's preclinical transient receptor potential vanilloid sub-family 1 (TRPV-1) antagonist molecule for treating pain, the companies announced Jan 9. In retum , Tokyo-based Mochida will be paid developmental milestones, an up-front fee and royalties on future sales.
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Russ Somma, Ph.D - Journal of Pharmaceutical Innovation, December 2007
This article explores the processes used in developing a market formulation and requisite supportive data, particularly in light of the industry’s current movement toward submissions based on quality by design (QbD).
http://springerlink.com
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Russ Somma, Ph.D - Pharmaceutical Executive, November 2007
Approval letters delay NDAs, cost pharma plenty, and are at an all-time high.
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Using Technology Transfer to Maximize Business Efficiency
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Aspects of Non-Invasive Drug Therapy – a Technology Viewpoint
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Early Career Forum with an Industry Focus Held at the International Design Engineering Technical Conferences
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Developing and Implementing a Certification Program to Drive Change in the Pharmaceutical Industry;
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L. Lee, R. Somma, et al.," In vitro dissolution and in vivo oral absorption of methylphenidate from
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"Novartis using PAT with aid of IVIVC; exec. Sees continued three batch validation", Validation Time
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"FDA/ISPE guidelines ease regulatory burdens", CleanRooms, November 1998
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Development of the Pharmaceutical Technology Technical Training Module, March 20, 1998
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"ISPE Honored with Hammer Award", ISPE iSpeak, January 1998
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"FDA-Industry Partnership Wins Hammer", CDER News Along the Pike, November 1997
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Center for Drug Evaluation and Research's Fall Honor Awards 1997
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Department of Health & Human Services, April 7, 1997
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J.Bara and R.Somma "Influence of the Physicochemical Variability of Magnesium Stearate on Its Lubric
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FDA Field Investigator Training Program "Time Release Technology, Matrix Tablets" (1991, 1992, 1994,
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Embracing Quality by Design: Applying QbD concepts can help CMOs create value
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Arden House 1989, "Solids Unit Processes: Theory, Practice and Optimization, Case Studies in Granula
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