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Biosimilars approval process

• Authors : Zuñiga, Leyre¹; Calvo, Begoña

Subjects: *THERAPEUTIC equivalency in drugs; *DRUG efficacy; *MEDICATION safety

• Source: Regulatory Toxicology & Pharmacology: RTP. Apr2010, Vol. 56 Issue 3, p374-377. 4p.

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Pharmacokinetics and pharmacodynamics of JR-051, a biosimilar of agalsidase beta, in healthy adults and patients with Fabry disease: Phase I and II/III clinical studies.

• Authors : Nakamura, Kimitoshi¹ (AUTHOR) ; Kawashima, Satoshi² (AUTHOR); Tozawa, Hirotaka² (AUTHOR)

Subjects: *THERAPEUTIC equivalency in drugs; *ANGIOKERATOMA corporis diffusum; *PHARMACODYNAMICS

• Source: Molecular Genetics & Metabolism. Jul2020, Vol. 130 Issue 3, p215-224. 10p.

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Method development and validation of sildenafil, N-desmethylsildenafil and N1,N4-desmethylsildenafil by LC-MS/MS and its application.

• Authors : Xu, Yan-Ying¹ (AUTHOR); Qin, Fei^1,2 (AUTHOR); Dai, Yi-Xin³ (AUTHOR)

Subjects: *THERAPEUTIC equivalency in drugs; *LIQUID chromatography-mass spectrometry; *SILDENAFIL

• Source: Analytical Biochemistry. Oct2021, Vol. 631, pN.PAG-N.PAG. 1p.

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Featured Articles.

Subjects: *CYSTIC fibrosis; *THERAPEUTIC equivalency in drugs; *PANCREATIC duct

• Source: Journal of Surgical Research. Feb2020, Vol. 246, piii-iii. 1p.

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Testing for correlation between traits under directional evolution.

• Authors : Royer-Carenzi, Manuela¹ (AUTHOR); Didier, Gilles^1,2 (AUTHOR)

Subjects: *THERAPEUTIC equivalency in drugs; *BROWNIAN motion; *BIOLOGICAL evolution

• Source: Journal of Theoretical Biology. Dec2019, Vol. 482, pN.PAG-N.PAG. 1p.

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Clinical utility of topiramate extended-release capsules (USL255): Bioequivalence of USL255 sprinkled and intact capsule in healthy adults and an in vitro evaluation of sprinkle delivery via enteral feeding tubes.

• Authors : Clark, Annie M.¹ ; Pellock, John M.²; Holmay, Mary¹

Subjects: *TOPIRAMATE; *THERAPEUTIC equivalency in drugs; *TREATMENT of epilepsy

• Source: Epilepsy & Behavior. Apr2016 Part A, Vol. 57, p105-110. 6p.

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Nanoparticle iron medicinal products – Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies

• Authors : Borchard, Gerrit¹ ; Flühmann, Beat²; Mühlebach, Stefan³

Subjects: *NANOMEDICINE; *THERAPEUTIC equivalency in drugs; *DRUG bioavailability

• Source: Regulatory Toxicology & Pharmacology: RTP. Nov2012, Vol. 64 Issue 2, p324-328. 5p.

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Comparison of bioequivalence study regulatory requirements for human and veterinary drugs

• Authors : Grabowski, Tomasz¹ ; Marczak, Monika² ; Jaroszewski, Jerzy Jan³

Subjects: *THERAPEUTIC equivalency in drugs; *VETERINARY drugs; *BODY weightEUROPEAN Union ; EUROPEAN Medicines Agency ; EUROPEAN Commission

• Source: Regulatory Toxicology & Pharmacology: RTP. Nov2012, Vol. 64 Issue 2, p233-242. 10p.

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The therapeutic equivalence of complex drugs

• Authors : Schellekens, Huub^1,2 ; Klinger, Ety³ ; Mühlebach, Stefan⁴

Subjects: *THERAPEUTIC equivalency in drugs; *BIOLOGICALS; *CARBOHYDRATESEUROPEAN Medicines Agency

• Source: Regulatory Toxicology & Pharmacology: RTP. Feb2011, p176-183. 8p.

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Evaluation of bioequivalence of isoniazid and pyrazinamide in three and four drugs fixed dose combinations using WHO simplified protocol

• Authors : Panchagnula, Ramesh ; Sancheti, Pavankumar¹; Rungta, Shradha¹

Subjects: *RIFAMPIN; *THERAPEUTIC equivalency in drugs; *TUBERCULOSIS

• Source: Pharmacological Research. Oct2003, Vol. 48 Issue 4, p383. 5p.

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