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Analysis of institutional authors

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December 4, 2024
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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

Publicated to: AAPS PHARMSCITECH. 15 (3): 665-693 - 2014-06-01 15(3), DOI: 10.1208/s12249-014-0087-x

Authors:

Van Buskirk, Glenn A; Asotra, Satish; Balducci, Christopher; Basu, Prabir; DiDonato, Gerald; Dorantes, Angelica; Eickhoff, W Mark; Ghosh, Tapash; Gonzalez, Mario A; 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; Sanchez, Eric; Shao, Zezhi Jesse; Somma, Russell; Tammara, Vijay; Thombre, Avinash G; Thompson, Bruce; Timko, Robert J; Upadrashta, Satyam; Vaithiyalingam, Sivakumar
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Affiliations

AbbVie, N Chicago, IL 60064 USA - Author
AHI Inc, Brampton, ON L6W 4K4, Canada - Author
Arena Pharmaceut, San Diego, CA 92121 USA - Author
AstraZeneca LP, Wilmington, DE 19850 USA - Author
Boehringer Ingelheim VetMed Inc, St Joseph, MO 64506 USA - Author
Bristol Myers Squibb Co, Pennington, NJ 08534 USA - Author
Genentech Inc, San Francisco, CA 94080 USA - Author
Janssen Ortho LLC, Gurabo, PR 00778 USA - Author
Janssen Res & Dev LLC, Spring House, PA 19477 USA - Author
McNeil Consumer Healthcare, Ft Washington, PA USA - Author
Merck & Co Inc, West Point, PA 19486 USA - Author
Millennium Pharmaceut Inc, Cambridge, MA 02139 USA - Author
Natl Inst Pharmaceut Technol & Engn NIPTE, Prospect, IL 60056 USA - Author
Nonclin Drug Dev Consulting Serv LLC, Basking Ridge, NJ 07920 USA - Author
Novartis Pharmaceut, E Hanover, NJ 07936 USA - Author
Nuron Biotech Inc, Exton, PA 19341 USA - Author
Pfizer Inc, Groton, CT 06340 USA - Author
PK Noonan & Associates LLC, Williamsburg, VA 23188 USA - Author
PKinet Int Inc, Pembroke Pines, FL 33027 USA - Author
Purdue Pharma LP, Cranbury, NJ 08512 USA - Author
Somma Tech Consulting, Somerset, NJ 08873 USA - Author
Summit Pharma Solut LLC, South Windsor, CT USA - Author
Sun Pharma USA, Cranbury, NJ 08512 USA - Author
Teva Pharmaceut, Pomona, NY 10970 USA - Author
US FDA, Silver Spring, MD 20993 USA - Author
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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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Keywords

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Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal AAPS PHARMSCITECH due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2014, it was in position , thus managing to position itself as a Q1 (Primer Cuartil), in the category Pharmaceutical Science.

Independientemente del impacto esperado determinado por el canal de difusión, es importante destacar el impacto real observado de la propia aportación.

Según las diferentes agencias de indexación, el número de citas acumuladas por esta publicación hasta la fecha 2026-04-06:

  • WoS: 22
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Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2026-04-06:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 135.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 135 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 14.
  • The number of mentions on the social network X (formerly Twitter): 1 (Altmetric).
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Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: Canada; United States of America.

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