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Items: 1 to 20 of 86

1.

How Many Batches Are Needed for Process Validation under the New FDA Guidance?

Yang H.

PDA J Pharm Sci Technol. 2013 Jan-Feb;67(1):53-62. doi: 10.5731/pdajpst.2013.00902.

PMID:
23385564
2.

Risk-based Methodology for Validation of Pharmaceutical Batch Processes.

Wiles F.

PDA J Pharm Sci Technol. 2013 Jul-Aug;67(4):387-98. doi: 10.5731/pdajpst.2013.00923.

PMID:
23872447
3.

Stage 2 Process Performance Qualification (PPQ): a Scientific Approach to Determine the Number of PPQ Batches.

Pazhayattil A, Alsmeyer D, Chen S, Hye M, Ingram M, Sanghvi P.

AAPS PharmSciTech. 2016 Aug;17(4):829-33. doi: 10.1208/s12249-015-0409-7. Epub 2015 Sep 8. Review.

PMID:
26349690
4.

Bayesian assurance and sample size determination in the process validation life-cycle.

Faya P, Seaman JW Jr, Stamey JD.

J Biopharm Stat. 2017;27(1):159-174. doi: 10.1080/10543406.2016.1148717. Epub 2016 Feb 18.

PMID:
26891342
5.

Assessment Methodology for Process Validation Lifecycle Stage 3A.

Sayeed-Desta N, Pazhayattil AB, Collins J, Chen S, Ingram M, Spes J.

AAPS PharmSciTech. 2017 Jul;18(5):1881-1886. doi: 10.1208/s12249-016-0641-9. Epub 2016 Oct 6.

PMID:
27714700
6.

FDA 2011 process validation guidance: lifecycle compliance model.

Campbell C.

PDA J Pharm Sci Technol. 2014 Mar-Apr;68(2):185-91. doi: 10.5731/pdajpst.2014.00972.

PMID:
24668605
7.
8.

A Bayesian Approach to Determination of F, D, and Z Values Used in Steam Sterilization Validation.

Faya P, Stamey JD, Seaman JW Jr.

PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):88-98. doi: 10.5731/pdajpst.2016.006981. Epub 2016 Oct 27.

PMID:
27789802
9.

FDA use of international standards in the premarket review process.

Rechen E, Barth DJ, Marlowe D, Kroger L.

Biomed Instrum Technol. 1998 Sep-Oct;32(5):518-26.

PMID:
9800008
11.

Challenges and opportunities in implementing the FDA default parametric tolerance interval two one-sided test for delivered dose uniformity of orally inhaled products.

Larner G, Cooper A, Lyapustina S, Leiner S, Christopher D, Strickland H, Golden M, Delzeit HJ, Friedman EM.

AAPS PharmSciTech. 2011 Dec;12(4):1144-56. doi: 10.1208/s12249-011-9683-1. Epub 2011 Sep 8.

12.

Bayesian hierarchical modeling of drug stability data.

Chen J, Zhong J, Nie L.

Stat Med. 2008 Jun 15;27(13):2361-80. doi: 10.1002/sim.3220.

PMID:
18338325
13.

A Bayesian approach to the ICH Q8 definition of design space.

Peterson JJ.

J Biopharm Stat. 2008;18(5):959-75. doi: 10.1080/10543400802278197.

PMID:
18781528
14.

Sterilizing filtration of liposome and related lipid-containing solutions: enhancing successful filter qualification.

Folmsbee M, Moussourakis M.

PDA J Pharm Sci Technol. 2012 Mar-Apr;66(2):161-7. doi: 10.5731/pdajpst.2012.00771.

PMID:
22492601
15.

[A proposal for reforming psychologists' training in France and in the European Union].

Bouchard JP.

Encephale. 2009 Feb;35(1):18-24. doi: 10.1016/j.encep.2007.11.008. Epub 2008 Apr 2. French.

PMID:
19250989
16.

Quality Risk Management: Putting GMP Controls First.

O'Donnell K, Greene A, Zwitkovits M, Calnan N.

PDA J Pharm Sci Technol. 2012 May-Jun;66(3):243-61. doi: 10.5731/pdajpst.2012.00859.

PMID:
22634590
17.

Risk analysis of sterile production plants: a new and simple, workable approach.

Gapp G, Holzknecht P.

PDA J Pharm Sci Technol. 2011 May-Jun;65(3):217-26. doi: 10.5731/pdajpst.2011.00693.

PMID:
22293233
18.

Setting Specifications of Correlated Quality Attributes through Multivariate Statistical Modelling.

Yang H.

PDA J Pharm Sci Technol. 2013 Sep-Oct;67(5):533-43. doi: 10.5731/pdajpst.2013.00935.

PMID:
24084662
19.

Application of quality by design principles to the development and technology transfer of a major process improvement for the manufacture of a recombinant protein.

Looby M, Ibarra N, Pierce JJ, Buckley K, O'Donovan E, Heenan M, Moran E, Farid SS, Baganz F.

Biotechnol Prog. 2011 Nov-Dec;27(6):1718-29. doi: 10.1002/btpr.672. Epub 2011 Sep 21.

PMID:
21948302
20.

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