Pharmacokinetics definitions in regulatory documents: transfer from small molecules into biologics-Reference-Cited by-同舟云学术

Pharmacokinetics definitions in regulatory documents: transfer from small molecules into biologics

Published:2016-10 Issue:1 Volume:1 Page:9-11
ISSN:2053-0846
Container-title:International Journal of Pharmacokinetics
language:en
Short-container-title:International Journal of Pharmacokinetics

Author:

Grabowski Tomasz¹,Marczak Monika²,Okoniewska Krystyna³

Affiliation:

1. Polpharma Biologics Trzy lipy 3, 80-172 Gdańsk, Poland

2. Dofarm, Aksamitna 15, 05-870 Błonie, Poland

3. P.F.O. Vetos-Farma sp. z o. o., Dzierżoniowska 21, 58-260 Bielawa, Poland

Publisher

Future Science Ltd

Link

http://www.future-science.com/doi/pdf/10.4155/ipk-2016-0012

Reference11 articles.

1. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product guidance for industry (2015). www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf.

2. US Food and Drug Administration. Guidance for industry bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA (2013). www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm377465.pdf.

3. A Novel Approach to Evaluate the Pharmacokinetic Biocomparability of a Monoclonal Antibody Derived from Two Different Cell Lines Using Simultaneous Crossover Design

4. European Medicines Agency. Guideline on the investigation of bioequivalence CPMP/EWP/QWP/1401/98 Rev. 1/Corr (2010). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf.

5. World Health Organization. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability. Working document QAS/04.093/Rev.4 (2005). www.who.int/medicines/services/expertcommittees/pharmprep/QAS04_093Rev4_final.pdf.

Cited by 7 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Efficacy and safety of switching between biologics in chronic rhinosinusitis with nasal polyps or N-ERD;Rhinology Journal;2023-08-01

2. Crossover studies;Translational Sports Medicine;2023

3. Case Report: Dynamic Interdependencies Between Complementary and Alternative Medicine (CAM) Practice, Urinary Interleukin-6 Levels, and Fatigue in a Breast Cancer Survivor;Frontiers in Psychiatry;2021-06-02

4. Switching between biologics in severe asthma patients. When the first choice is not proven to be the best;Clinical & Experimental Allergy;2020-12-16

5. Impact of water hardness on oxytetracycline oral bioavailability in fed and fasted piglets;Veterinary Medicine and Science;2019-07-08