Overcoming Disincentives to Process Understanding in the Pharmaceutical CMC Environment - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Overcoming Disincentives to Process Understanding in the Pharmaceutical CMC Environment
Larger and strategic sampling and testing plans can improve process understanding and characterization.

Pharmaceutical Technology

17. S. Ruberg and J. Hsu, "Multiple Comparison Procedures for Pooling Batches in Stability Studies," Technometrics 34 (4), 465–472 (1992).

18. IPAC–RS, "A Parametric Tolerance Interval Test for Improved Control of Delivered Dose Uniformity of Orally Inhaled and Nasal Drug Products" (2001), http:// http://ipacrs.com/PDFs/IPAC-RS_DDU_Proposal.PDF.

19. PQRI BUWG, "The Use of Stratified Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for Powder Blends," PDA J. Pharm. Sci. Technol. 57 (2), 64 –74 (2003).

20. W. Hauck et al., "Oral Dosage Form Performance Tests: New Dissolution Approaches," Pharm. Res. 22 (2), 182–187 (2005).

21. R. Williams et al., "Content Uniformity and Dose Uniformity: Current Approaches, Statistical Approaches, and Presentation of an Alternative Approach, with Special Reference to Oral Inhalation and Nasal Drug Products," Pharm. Res. 19 (4), 359–366 (2002).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here