Principles for Management of Extractables and Leachables in Ophthalmic Drug Products

Christopher Houston; Andrea Desantis Rodrigues; Brenda Birkestrand Smith; Tao Wang; Mary Richardson

doi:10.5731/pdajpst.2022.012744

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Principles for Management of Extractables and Leachables in Ophthalmic Drug Products

Christopher Houston, Andrea Desantis Rodrigues, Brenda Birkestrand Smith, Tao Wang and Mary Richardson

PDA Journal of Pharmaceutical Science and Technology February 2022, pdajpst.2022.012744; DOI: https://doi.org/10.5731/pdajpst.2022.012744

Christopher Houston

1 Bausch & Lomb;

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For correspondence: christopher.houston@bausch.com

Andrea Desantis Rodrigues

2 PYC Therapeutics;

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For correspondence: andrea.rodrigues@pyctx.com

Brenda Birkestrand Smith

3 Vir Biotechnology, Inc.;

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For correspondence: bsmith@vir.bio

Tao Wang

4 AbbVie;

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For correspondence: tao.wang@abbvie.com

Mary Richardson

5 iuvo BioScience

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For correspondence: mary.richardson@iuvobioscience.com

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pdajpst.2022.012744

DOI

https://doi.org/10.5731/pdajpst.2022.012744

PubMed

35169039

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received February 4, 2022
Accepted February 11, 2022
Published online February 15, 2022.

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You are currently viewing a previous version of this article (February 15, 2022 - 08:07).
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Author Information

Christopher Houston1,6 (christopher.houston{at}bausch.com),
Andrea Desantis Rodrigues2 (andrea.rodrigues{at}pyctx.com),
Brenda Birkestrand Smith3 (bsmith{at}vir.bio),
Tao Wang4 (tao.wang{at}abbvie.com) and
Mary Richardson5 (mary.richardson{at}iuvobioscience.com)

¹ Bausch & Lomb;
² PYC Therapeutics;
³ Vir Biotechnology, Inc.;
⁴ AbbVie;
⁵ iuvo BioScience

↵* Corresponding author; email: christopher.houston{at}bausch.com

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PDA Journal of Pharmaceutical Science and Technology

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January/February 2025

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Principles for Management of Extractables and Leachables in Ophthalmic Drug Products

Christopher Houston, Andrea Desantis Rodrigues, Brenda Birkestrand Smith, Tao Wang, Mary Richardson

PDA Journal of Pharmaceutical Science and Technology Feb 2022, pdajpst.2022.012744; DOI: 10.5731/pdajpst.2022.012744

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Principles for Management of Extractables and Leachables in Ophthalmic Drug Products

Christopher Houston, Andrea Desantis Rodrigues, Brenda Birkestrand Smith, Tao Wang, Mary Richardson

PDA Journal of Pharmaceutical Science and Technology Feb 2022, pdajpst.2022.012744; DOI: 10.5731/pdajpst.2022.012744

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Keywords

Endpoints
Extractables
Leachables
Ophthalmics
Simulation
Toxicity

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