Results 11 to 20 of about 80,706 (309)

Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence

Journal of Pharmacy & Pharmaceutical Sciences, 2016
Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP ...
Maki Matsuhama, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, Kenichi Mikami   +5 more
doaj   +1 more source

Interchangeability of Generic Drugs: A Nonparametric Pharmacokinetic Model of Gabapentin Generic Drugs [PDF]

Clinical Pharmacology & Therapeutics, 2018
Substitution by generic drugs is allowed when bioequivalence to the originator drug has been established. However, it is known that similarity in exposure may not be achieved at every occasion for all individual patients when switching between formulations.
Glerum, Pieter J., Yu, Y., Yamada, Walter M., Neely, M.N., Maliepaard, M., Burger, D.M., Neef, C.   +6 more
openaire   +3 more sources

An Indian effort towards affordable drugs: "generic to designer drugs" [PDF]

, 2009
This review discusses the progress of India from being one of the largest producers of generics to its coming of age and initiating novel drug development programs such as the Open Source Drug Discovery for tuberculosis. A few groups have also begun to
Brahmachari, Samir K., Chakraborty, Tushar K., Taneja, Bhupesh, Yadav, Jyoti   +3 more
core   +1 more source

Information Extraction From FDA Drug Labeling to Enhance Product-Specific Guidance Assessment Using Natural Language Processing

Frontiers in Research Metrics and Analytics, 2021
Towards the objectives of the UnitedStates Food and Drug Administration (FDA) generic drug science and research program, it is of vital importance in developing product-specific guidances (PSGs) with recommendations that can facilitate and guide generic ...
Yiwen Shi, Ping Ren, Yi Zhang, Xiajing Gong, Meng Hu, Hualou Liang   +5 more
doaj   +1 more source

Copies of nonbiological complex drugs: generic, hybrid or biosimilar? [PDF]

, 2019
The experience gained with biosimilars has made it clear that copies of complex drugs are more challenging to produce and put on the market than generics.
Franzè, Silvia, Musazzi, Umberto M, Minghetti, Paola, Rocco, Paolo   +3 more
core   +1 more source

Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
This workshop report summarizes the presentations and panel discussion related to the use of physiologically based pharmacokinetic (PBPK) modeling approaches for food effect assessment, collected from Session 2 of Day 2 of the workshop titled “Regulatory
Abdullah Al Shoyaib, Arian Emami Riedmaier, Anita Kumar, Partha Roy, Neil John Parrott, Lanyan Fang, Nilufer Tampal, Yuching Yang, Rebeka Jereb, Liang Zhao, Fang Wu   +10 more
doaj   +1 more source

On the robustness of generalization of drug–drug interaction models [PDF]

BMC Bioinformatics, 2021
Abstract Background Deep learning methods are a proven commodity in many fields and endeavors. One of these endeavors is predicting the presence of adverse drug–drug interactions (DDIs). The models generated can predict, with reasonable accuracy, the phenotypes arising from the drug interactions using their molecular ...
Rogia Kpanou, Mazid Abiodoun Osseni, Prudencio Tossou, François Laviolette, Jacques Corbeil   +4 more
openaire   +3 more sources

Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
For approval, a proposed generic drug product must demonstrate it is bioequivalent (BE) to the reference listed drug product. For locally acting drug products, conventional BE approaches may not be feasible because measurements in local tissues at the ...
Ming‐Liang Tan, Sajeev Chandran, Rebeka Jereb, Khondoker Alam, Robert Bies, Darby Kozak, Ross Walenga, Maxime Le Merdy, Andrew Babiskin   +8 more
doaj   +1 more source

Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview

CPT: Pharmacometrics & Systems Pharmacology, 2023
On September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence ...
Andrew Babiskin, Fang Wu, Youssef Mousa, Ming‐Liang Tan, Eleftheria Tsakalozou, Ross L. Walenga, Miyoung Yoon, Sam G. Raney, James E. Polli, Anna Schwendeman, Vishalakshi Krishnan, Lanyan Fang, Liang Zhao   +12 more
doaj   +1 more source

Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs

Pharmaceutics, 2023
One of the potential essential factors that restricts generic industry from applying the Biopharmaceutics Classification System (BCS) Class III biowaiver is adherence to the stringent formulation criteria for formulation qualitative (Q1) sameness and ...
Ping Ren, Theresa Chan, Wen-Cheng Yang, Mitchell Frost, Yan Wang, Markham Luke, Myong-Jin Kim, Robert Lionberger, Yi Zhang   +8 more
doaj   +1 more source