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Using the refined Developability Classification System (rDCS) to guide the design of oral formulations.

• Authors : Beran, Kristian^1,2 (AUTHOR); Hermans, Eline² (AUTHOR); Holm, René³ (AUTHOR)

Subjects: *BIOPHARMACEUTICS; *VORICONAZOLE; *PHARMACOKINETICS

• Source: Journal of Pharmaceutical Sciences. Dec2024, Vol. 113 Issue 12, p3497-3517. 21p.

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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fexofenadine.

• Authors : Charoo, Naseem A.¹ (AUTHOR); Selvasudha, N.² (AUTHOR); Kath, Zahira Nala¹ (AUTHOR)

Subjects: *SOLID dosage forms; *BIOPHARMACEUTICS; *FEXOFENADINE

• Source: Journal of Pharmaceutical Sciences. Sep2024, Vol. 113 Issue 9, p2981-2993. 13p.

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Review of embryo-fetal developmental toxicity studies performed for pharmaceuticals approved by FDA in 2022 and 2023.

• Authors : Barrow, Paul¹ (AUTHOR)

Subjects: *SMALL molecules; *BIOPHARMACEUTICS; *PRIMATES

• Source: Reproductive Toxicology. Dec2024, Vol. 130, pN.PAG-N.PAG. 1p.

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Development of Extended-Release Formulations Containing Cyclobenzaprine Based on Physiologically Based Biopharmaceutics Modeling and Bioequivalence Safe Space.

• Authors : Miranda dos Santos, Everton¹ (AUTHOR); Ferraz, Humberto Gomes² (AUTHOR); Issa, Michele Georges² (AUTHOR)

Subjects: *BIOPHARMACEUTICS; *DRUG solubility; *CROSSOVER trials

• Source: Journal of Pharmaceutical Sciences. Dec2023, Vol. 112 Issue 12, p3131-3140. 10p.

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Education Full Text (H.W. Wilson)

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Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives.

• Authors : Kollipara, Sivacharan¹ (AUTHOR); Martins, Frederico S.² (AUTHOR); Sanghavi, Maitri³ (AUTHOR)

Subjects: *WAIVER; *BIOPHARMACEUTICS; *GENERIC products

• Source: Journal of Pharmaceutical Sciences. Feb2024, Vol. 113 Issue 2, p345-358. 14p.

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Dissolution-Hollow Fiber Membrane (D-HFM) System to Anticipate Biopharmaceutics Risk of Tablets and Capsules.

• Authors : Adhikari, Asmita¹ (AUTHOR); Seo, Paul R.² (AUTHOR); Polli, James E.¹ (AUTHOR)

Subjects: *BIOPHARMACEUTICS; *SOLID dosage forms; *DRUG absorption

• Source: Journal of Pharmaceutical Sciences. Mar2023, Vol. 112 Issue 3, p751-759. 9p.

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S07-01 The current landscape of non-animal preclinical assessment for biopharmaceuticals.

• Authors : Grode, L.¹ (AUTHOR)

Subjects: *BIOPHARMACEUTICS

• Source: Toxicology Letters. 2024 Supplement 2, Vol. 399, pS20-S20. 1p.

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Novel EDTA mediated ethanol protein precipitation method and the application for polysorbate quantification in high protein concentration biopharmaceuticals.

• Authors : Halim, Vincentius A.¹ (AUTHOR) ; de Jonker, Maurice¹ (AUTHOR); Esteve, Clara¹ (AUTHOR)

Subjects: *PRECIPITATION (Chemistry); *BIOPHARMACEUTICS; *NONIONIC surfactants

• Source: Journal of Pharmaceutical & Biomedical Analysis. Aug2024, Vol. 245, pN.PAG-N.PAG. 1p.

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Drug Permeability - Best Practices for Biopharmaceutics Classification System (BCS)-Based Biowaivers: A workshop Summary Report.

• Authors : Mehta, M.¹ (AUTHOR) ; Polli, J.E.² (AUTHOR); Seo, P.¹ (AUTHOR)

Subjects: *BIOPHARMACEUTICS; *BEST practices; *DRUG developmentINDIANAUNITED States. Food & Drug Administration

• Source: Journal of Pharmaceutical Sciences. Jul2023, Vol. 112 Issue 7, p1749-1762. 14p.

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