A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2.

García-Arieta A, Tam A, Tiseyra F, Fernandes EAF, Soares KCC, Pereira RS, Potthast H, Mettke K, Chang YW, Hsu LF, Su YL, Martínez ZR, Divinsky M, Blake K, Braddy AC, Rodrigues C, Toh T, Aurela EG, González LCA, Jones B, Kim SH, Ahn C, Yun E, Kuribayashi R, Shimojo K, Kasuga M, Makino J, Raffel J, van Oudtshoorn J, Tabane P, Alzenaidy B, AlHarbi M, Alharf A, BinAjlan A, Walther C, Roost MS, Crane C, Lee K

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DOI: 10.3389/jpps.2025.14721
Published: 2025
Container: Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques
Publisher: Not recorded
Open access: yes

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Cite this work

BibTeX

@article{allodium:10.3389/jpps.2025.14721,
  title = {A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2.},
  author = {García-Arieta A and Tam A and Tiseyra F and Fernandes EAF and Soares KCC and Pereira RS and Potthast H and Mettke K and Chang YW and Hsu LF and Su YL and Martínez ZR and Divinsky M and Blake K and Braddy AC and Rodrigues C and Toh T and Aurela EG and González LCA and Jones B and Kim SH and Ahn C and Yun E and Kuribayashi R and Shimojo K and Kasuga M and Makino J and Raffel J and van Oudtshoorn J and Tabane P and Alzenaidy B and AlHarbi M and Alharf A and BinAjlan A and Walther C and Roost MS and Crane C and Lee K},
  year = {2025},
  journal = {Journal of pharmacy \& pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques},
  doi = {10.3389/jpps.2025.14721},
  url = {https://doi.org/10.3389/jpps.2025.14721}
}

RIS

TY  - JOUR
TI  - A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2.
AU  - García-Arieta A
AU  - Tam A
AU  - Tiseyra F
AU  - Fernandes EAF
AU  - Soares KCC
AU  - Pereira RS
AU  - Potthast H
AU  - Mettke K
AU  - Chang YW
AU  - Hsu LF
AU  - Su YL
AU  - Martínez ZR
AU  - Divinsky M
AU  - Blake K
AU  - Braddy AC
AU  - Rodrigues C
AU  - Toh T
AU  - Aurela EG
AU  - González LCA
AU  - Jones B
AU  - Kim SH
AU  - Ahn C
AU  - Yun E
AU  - Kuribayashi R
AU  - Shimojo K
AU  - Kasuga M
AU  - Makino J
AU  - Raffel J
AU  - van Oudtshoorn J
AU  - Tabane P
AU  - Alzenaidy B
AU  - AlHarbi M
AU  - Alharf A
AU  - BinAjlan A
AU  - Walther C
AU  - Roost MS
AU  - Crane C
AU  - Lee K
PY  - 2025
JO  - Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques
DO  - 10.3389/jpps.2025.14721
UR  - https://doi.org/10.3389/jpps.2025.14721
ER  -

APA

A, G., A, T., F, T., EAF, F., KCC, S., RS, P., H, P., K, M., YW, C., LF, H., YL, S., ZR, M., M, D., K, B., AC, B., C, R., T, T., EG, A., LCA, G., B, J., SH, K., C, A., E, Y., R, K., K, S., M, K., J, M., J, R., J, V. O., P, T., B, A., M, A., A, A., A, B., C, W., MS, R., C, C., & K, L. (2025). A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2.. Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques. https://doi.org/10.3389/jpps.2025.14721

Source records

pubmed · retrieved 2026-09-25T06:39:48.881Z
doaj · retrieved 2026-09-25T06:39:48.871Z