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Book Review: Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals.

• Authors : Brock, William J.¹ (AUTHOR)

Subjects: *TRANSLATIONAL research; *BIOPHARMACEUTICS; *SMALL molecules

• Source: International Journal of Toxicology (Sage). Sep2022, Vol. 41 Issue 5, p420-422. 3p.

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Education Full Text (H.W. Wilson)

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Alternatives to Monkey Reproductive Toxicology Testing for Biotherapeutics.

• Authors : Hoberman, Alan M.; Maki, Kazushige; Mikashima, Fumito

Subjects: REPRODUCTIVE toxicology; TOXICITY testing; DEVELOPMENTAL toxicologyUNITED States. Food & Drug Administration

• Source: International Journal of Toxicology (Sage); Dec2023, Vol. 42 Issue 6, p467-479, 13p

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Commentary: Bioequivalence, interchangeability and perceptions.

• Authors : Thiessen, Jake J.¹

Subjects: *THERAPEUTIC equivalency in drugs; *BIOPHARMACEUTICS; *PRODUCT management

• Source: Journal of Generic Medicines. Apr2005, Vol. 2 Issue 3, p209-211. 3p.

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Evaluation of In-Line Raman Spectroscopic Monitoring of Size Reduction During Wet Media Milling of Biopharmaceutics Classification System Class II Drugs.

• Authors : Ying, Ye; Afolabi, Afolawemi; Bilgili, Ecevit

Subjects: *SIZE reduction of materials; *BIOPHARMACEUTICS; *MILLING machinery

• Source: Applied Spectroscopy. Dec2014, Vol. 68 Issue 12, p1411-1417. 7p.

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Opinion on Current Use of Non-Blinded Versus Blinded Histopathologic Evaluation in Animal Toxicity Studies.

• Authors : Bolon, Brad¹ (AUTHOR) ; Caverly Rae, Jessica M.² (AUTHOR); Colman, Karyn³ (AUTHOR)

Subjects: *CONTRACT research organizations; *BIOPHARMACEUTICS; *SURVEYS

• Source: Toxicologic Pathology. Jun2020, Vol. 48 Issue 4, p549-559. 11p.

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Beyond the Guidelines: Treatment of Allergic Bronchopulmonary Aspergillosis in Cystic Fibrosis.

• Authors : Tompkins, Madeline G.; Pettit, Rebecca

Subjects: PULMONARY aspergillosis; CYSTIC fibrosis; CORTICOSTEROIDS

• Source: Annals of Pharmacotherapy; Feb2022, Vol. 56 Issue 2, p181-192, 12p

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Nonhuman primates: their role in assessing developmental effects of immunomodulatory agents.

• Authors : Hendrickx, A.G.¹; Makori, N.¹; Peterson, P.¹

Subjects: *MACAQUES; *BIOPHARMACEUTICS; *TERATOLOGY

• Source: Human & Experimental Toxicology. Apr2000, Vol. 19 Issue 4, p219-225. 7p.

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Scientific and Regulatory Policy Committee Points to Consider: Histopathologic Evaluation in Safety Assessment Studies for PEGylated Pharmaceutical Products.

• Authors : Irizarry Rovira, Armando R.¹ ; Bennet, Bindu M.²; Bolon, Brad³

Subjects: *BIOPHARMACEUTICS; *POLYETHYLENE glycol; *IMMUNOHISTOCHEMISTRY

• Source: Toxicologic Pathology. Aug2018, Vol. 46 Issue 6, p616-635. 20p.

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Applications of Raman Spectroscopy in Biopharmaceutical Manufacturing: A Short Review.

• Authors : Buckley, Kevin¹; Ryder, Alan G.¹

Subjects: *RAMAN spectroscopy; *BIOPHARMACEUTICS; *DRUG factories

• Source: Applied Spectroscopy. Jun2017, Vol. 71 Issue 6, p1085-1116. 32p.

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