| nr |
titel |
auteur |
tijdschrift |
jaar |
jaarg. |
afl. |
pagina('s) |
type |
| 1 |
Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use
|
Fang, Lanyan
|
|
|
42 |
5 |
p. 731-735
|
artikel
|
| 2 |
Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization
|
Cheng, Yi-Hsien
|
|
|
42 |
5 |
p. 819-833
|
artikel
|
| 3 |
Assessing Impact of Food on Oral Drug Bioequivalence Supporting ICH M13 A with the Advancements of Physiologically Based Pharmacokinetic Modeling
|
Pal, Arindom
|
|
|
42 |
5 |
p. 835-845
|
artikel
|
| 4 |
Considerations for Regulatory Reusability of Dynamic Tools in the New Drug Development
|
Liu, Jiang
|
|
|
42 |
5 |
p. 765-771
|
artikel
|
| 5 |
Considering Opportunities and Challenges When Implementing the Model Master File Framework – a Meeting Report
|
Tsakalozou, Eleftheria
|
|
|
42 |
5 |
p. 737-746
|
artikel
|
| 6 |
Correction: Leveraging Model Master Files for Long-Acting Injectables
|
Gong, Yuqing
|
|
|
42 |
5 |
p. 857
|
artikel
|
| 7 |
Immunogenicity of Generic Peptide Impurities: Current Orthogonal Approaches
|
De Groot, Anne S.
|
|
|
42 |
5 |
p. 805-818
|
artikel
|
| 8 |
Industry Perspectives on Implementation of Model Master File (MMF) Framework for Generics and Innovator Drugs: Opportunities, Challenges and Future Outlook
|
Kollipara, Sivacharan
|
|
|
42 |
5 |
p. 785-794
|
artikel
|
| 9 |
Leveraging Model Master Files for Long-Acting Injectables
|
Gong, Yuqing
|
|
|
42 |
5 |
p. 747-752
|
artikel
|
| 10 |
Leveraging Model Master Files from a Technology Company Perspective: Facilitating Quantitative Medicine in Regulatory Frameworks
|
De Backer, Jan
|
|
|
42 |
5 |
p. 795-803
|
artikel
|
| 11 |
Paving the Path for Increased Technological Innovation, Strategic Decision Making and Regulatory Acceptance of Modeling and Simulation Approaches
|
Fang, Lanyan
|
|
|
42 |
5 |
p. 727-729
|
artikel
|
| 12 |
PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations
|
Wu, Fang
|
|
|
42 |
5 |
p. 847-855
|
artikel
|
| 13 |
Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products
|
Walenga, Ross L.
|
|
|
42 |
5 |
p. 773-784
|
artikel
|
| 14 |
Using Model Master Files to Support Oral Drug Product Development and Regulatory Submissions
|
Cheng, Yi-Hsien
|
|
|
42 |
5 |
p. 753-763
|
artikel
|
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