Injectable Combination Product Development: Facilitating Risk-Based Assessments for Efficiency and Patient Centric Outcomes-Reference-Cited by-同舟云学术

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Injectable Combination Product Development: Facilitating Risk-Based Assessments for Efficiency and Patient Centric Outcomes

Published:2020-07 Issue:7 Volume:109 Page:2101-2115
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

DeGrazio Fran,Paskiet Diane

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference48 articles.

1. Effective method for drug injection into subcutaneous tissue;Kim;Sci Rep,2017

2. Injectable drug delivery: devices meet next-generation formulations;Karlsson;On Drug Deliv,2017

3. Evaluating the administration costs of biologic drugs: development of a cost algorithm;Tetteh;Geogr Nat Resour,2014

4. Guidance for Industry ICH Q11 Development and Manufacture of Drug Substances,2012

5. FDA perspectives on established conditions and ICH Q12;Boam,2016

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Ensuring safety and efficacy in combination products: regulatory challenges and best practices;Frontiers in Medical Technology;2024-07-10

2. Quality by Design in Pharmaceuticals: A Review of its Impact on Regulatory Compliance and Product Quality;Drug Research;2023-12-22

3. Considerations for the development of a field-based medical device for the administration of adjunctive therapies for snakebite envenoming;Toxicon: X;2023-12

4. Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access;BioDrugs;2023-10-13

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