Milestone News
Milestone News
The financial and productivity challenges facing the pharmaceutical industry call for a shift away from the traditional, fully-integrated pharmaceutical company toward collaborations that have mutual and measurable benefits for each party.
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In today’s challenging drug development environment, biopharmaceutical companies are seeking new paradigms to help them develop innovative therapies that are both time efficient and cost effective.
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Innovation is a word used liberally in the biotechnology and pharmaceutical sectors, yet we are seeing a new variation on the notion of innovation given both the current global economic pressures and the evolving needs of the industry and those we serve.
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This edition of Aptuit’s Milestones Newsletter explores the role of the qualified person in clinical trials in the EU, electronic solutions and submission, experimental screening methods to address polymorphism, and provides update on Aptuit’s joint venture in India, Aptuit Laurus.
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In this fourth edition of Aptuit's Milestones newsletter, Stephen Byrn, Ph.D., addresses the challenges
associated with FDA’s Critical Path Initiative and Eyal Barash describes the patent implications of new chemical entities and amorphous states. Technologies, facilities, and expertise within Aptuit's business units are also explored.
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In this third edition of Milestones read about the art of working with a VC backed company and Kunal Khattar, Executive Director, Aptuit Laurus, explores the current state of the Indian marketplace and partnering with a CRO in this emerging market.
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In this second edition of Milestones read about the shifting arena of drug development, the critical role of consulting, getting the right form first time and much much more.
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In the inaugural edition of Milestones, read about the changing dynamic of the drug development industry, service offerings at various Aptuit facilities around the world, Aptuit's recent acquisition of EaglePicher Pharmaceutical's API business, and much more.
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Other Publications
Other Publications
- Peter Gaskin, “,” Pharmaceutical Technology Europre, Volume 22, Issue 8, August 2010. Click here to view
- James A. Rogers, Matthew M. Riggs, Monte Coffiner, William R. Gillespie, Robert Burford et al., publish poster reviewing “Clinical Trial Simulation to Compare Adaptive and Fixed Designs for a Phase 3 Clinical Trial of Nacystelyn®,” at American Conference on Pharmacometrics, Mashantucket, CT, October 4–7, 2009. Click here to view
- Peter Gaskin, et al., Tyrosinemia produced by 2-(2-nitro-4-triflouromethylbenzoyl)-cyclohexane -1,3-dione (NTBC) in experimental animals and its relationship to corneal injury Toxicol Appl Pharmacol. 2006
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