Results 21 to 30 of about 4,484,991 (333)

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

Generic drugs

Journal of the Indian Medical Association, 2008
Sometimes it seems as though generic drugs are one of those things that everybody likes as an idea, but they wouldn’t want to take one themselves. Ireland is at the bottom of the European market by value, and second from bottom by volume. Exports of generics make up a significant proportion of total finished product pharmaceutical exports.
  +7 more sources

Analysis of Non-Pivotal Bioequivalence Studies Submitted in Abbreviated New Drug Submissions for Delayed-Release Drug Products

Journal of Pharmacy & Pharmaceutical Sciences, 2017
The US FDA’s rule on “Requirements for Submission of Bioequivalence Data” requiring submission of all bioequivalence (BE) studies conducted on the same formulation of the drug product submitted for approval was published in Federal Register in January ...
Paramjeet Kaur, Xiaojian Jiang, Ethan Stier   +2 more
doaj   +1 more source

Virtual screening FDA approved drugs against multiple targets of SARS‐CoV‐2

Clinical and Translational Science, 2021
The outbreak of the novel coronavirus severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2), the causative agent of coronavirus disease 2019 (COVID‐19) respiratory disease, led to a global pandemic with high morbidity and mortality.
Hualou Liang, Liang Zhao, Xiajing Gong, Meng Hu, Hongbin Wang   +4 more
doaj   +1 more source

Entry in the ADHD drugs market: Welfare impact of generics and me-toos [PDF]

, 2013
Recent decades have seen a growth in treatments for attention deficit hyperactivity disorder (ADHD) including many branded and generic drugs. In the early 2000's, new drug entry dramatically altered market shares.
Angell M., Barkley R. A., Bulow J., Conner D. F., Deaton A., FDAnews Drug Daily Bulletin, Frank R. G., Goozner M., Hausman J. A., Hausman J. A., Perwien A. R., Rector T. S., Safer D. J., Shulman S. R., Spencer T. J.   +14 more
core   +1 more source

The Future of Generic Biologics: Should the United States “Follow-On” the European Pathway? [PDF]

, 2008
The United States is embarking on a biotechnology drug revolution. In the last few decades, biotech drugs have saved millions of lives, and the market for these miracle cures continues to grow at an astronomical rate.
Kaldre, Ingrid
core   +4 more sources

Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

CPT: Pharmacometrics & Systems Pharmacology, 2021
Establishing bioequivalence (BE) for dermatological drug products by conducting comparative clinical end point studies can be costly and the studies may not be sufficiently sensitive to detect certain formulation differences.
Eleftheria Tsakalozou, Andrew Babiskin, Liang Zhao   +2 more
doaj   +1 more source

Generic Drugs in the United States: Policies to Address Pricing and Competition

Clinical pharmacology and therapy, 2019
The cost of prescription drugs in the United States continues to be a source of concern for patients, caregivers, and policymakers. Drug prices typically decline rapidly once generic drugs receive US Food and Drug Administration (FDA) approval and enter ...
Ravi Gupta, N. Shah, J. Ross
semanticscholar   +1 more source

Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop

CPT: Pharmacometrics & Systems Pharmacology, 2023
On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled “Establishing the Suitability of Model‐Integrated Evidence (MIE) to Demonstrate Bioequivalence ...
Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C. Hooker, Murray P. Ducharme, Jogarao Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V. Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James Polli, Lanyan Fang, Robert Lionberger, Liang Zhao   +17 more
doaj   +1 more source