Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm

Glenn A. Van Buskirk, Satish Asotra, Christopher Balducci, Prabir Basu, Gerald DiDonato, Angelica Dorantes, W. Mark Eickhoff, Tapash Ghosh, Mario A. González, Theresa Henry, Matthew Howard, Jason Kamm, Steven Laurenz, Ryan MacKenzie, Richard Mannion, Patrick K. Noonan, Terrance Ocheltree, Umesh Pai, Richard P. Poska, Michael L. Putnam & 12 others Ramani R. Raghavan, Colleen Ruegger, Eric Sánchez, Vinod P. Shah, Zezhi Jesse Shao, Russell Somma, Vijay Tammara, Avinash G. Thombre, Bruce Thompson, Robert J. Timko, Satyam Upadrashta, Sivakumar Vaithiyalingam

Research output: Contribution to journalReview article

11 Citations (Scopus)

Abstract

In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro-in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies.

Original languageEnglish
Pages (from-to)665-693
Number of pages29
JournalAAPS PharmSciTech
Volume15
Issue number3
DOIs
Publication statusPublished - 01-01-2014

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Dosage Forms
Drug Industry
Practice Guidelines
Documentation
manufacturing
Technology
process control
dosage
committees
product quality
chemistry
In Vitro Techniques
pharmaceutical industry

All Science Journal Classification (ASJC) codes

  • Agronomy and Crop Science
  • Pharmaceutical Science
  • Drug Discovery

Cite this

Van Buskirk, Glenn A. ; Asotra, Satish ; Balducci, Christopher ; Basu, Prabir ; DiDonato, Gerald ; Dorantes, Angelica ; Eickhoff, W. Mark ; Ghosh, Tapash ; González, Mario A. ; Henry, Theresa ; Howard, Matthew ; Kamm, Jason ; Laurenz, Steven ; MacKenzie, Ryan ; Mannion, Richard ; Noonan, Patrick K. ; Ocheltree, Terrance ; Pai, Umesh ; Poska, Richard P. ; Putnam, Michael L. ; Raghavan, Ramani R. ; Ruegger, Colleen ; Sánchez, Eric ; Shah, Vinod P. ; Shao, Zezhi Jesse ; Somma, Russell ; Tammara, Vijay ; Thombre, Avinash G. ; Thompson, Bruce ; Timko, Robert J. ; Upadrashta, Satyam ; Vaithiyalingam, Sivakumar. / Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm. In: AAPS PharmSciTech. 2014 ; Vol. 15, No. 3. pp. 665-693.
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abstract = "In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro-in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies.",
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Van Buskirk, GA, Asotra, S, Balducci, C, Basu, P, DiDonato, G, Dorantes, A, Eickhoff, WM, Ghosh, T, González, MA, Henry, T, Howard, M, Kamm, J, Laurenz, S, MacKenzie, R, Mannion, R, Noonan, PK, Ocheltree, T, Pai, U, Poska, RP, Putnam, ML, Raghavan, RR, Ruegger, C, Sánchez, E, Shah, VP, Shao, ZJ, Somma, R, Tammara, V, Thombre, AG, Thompson, B, Timko, RJ, Upadrashta, S & Vaithiyalingam, S 2014, 'Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm', AAPS PharmSciTech, vol. 15, no. 3, pp. 665-693. https://doi.org/10.1208/s12249-014-0087-x

Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm. / Van Buskirk, Glenn A.; Asotra, Satish; Balducci, Christopher; Basu, Prabir; DiDonato, Gerald; Dorantes, Angelica; Eickhoff, W. Mark; Ghosh, Tapash; González, Mario A.; Henry, Theresa; Howard, Matthew; Kamm, Jason; Laurenz, Steven; MacKenzie, Ryan; Mannion, Richard; Noonan, Patrick K.; Ocheltree, Terrance; Pai, Umesh; Poska, Richard P.; Putnam, Michael L.; Raghavan, Ramani R.; Ruegger, Colleen; Sánchez, Eric; Shah, Vinod P.; Shao, Zezhi Jesse; Somma, Russell; Tammara, Vijay; Thombre, Avinash G.; Thompson, Bruce; Timko, Robert J.; Upadrashta, Satyam; Vaithiyalingam, Sivakumar.

In: AAPS PharmSciTech, Vol. 15, No. 3, 01.01.2014, p. 665-693.

Research output: Contribution to journalReview article

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T1 - Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm

AU - Van Buskirk, Glenn A.

AU - Asotra, Satish

AU - Balducci, Christopher

AU - Basu, Prabir

AU - DiDonato, Gerald

AU - Dorantes, Angelica

AU - Eickhoff, W. Mark

AU - Ghosh, Tapash

AU - González, Mario A.

AU - Henry, Theresa

AU - Howard, Matthew

AU - Kamm, Jason

AU - Laurenz, Steven

AU - MacKenzie, Ryan

AU - Mannion, Richard

AU - Noonan, Patrick K.

AU - Ocheltree, Terrance

AU - Pai, Umesh

AU - Poska, Richard P.

AU - Putnam, Michael L.

AU - Raghavan, Ramani R.

AU - Ruegger, Colleen

AU - Sánchez, Eric

AU - Shah, Vinod P.

AU - Shao, Zezhi Jesse

AU - Somma, Russell

AU - Tammara, Vijay

AU - Thombre, Avinash G.

AU - Thompson, Bruce

AU - Timko, Robert J.

AU - Upadrashta, Satyam

AU - Vaithiyalingam, Sivakumar

PY - 2014/1/1

Y1 - 2014/1/1

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EP - 693

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