Results 21 to 30 of about 2,442,464 (298)

Pharmacological activities and effective substances of the component-based Chinese medicine of Ginkgo biloba leaves based on serum pharmacochemistry, metabonomics and network pharmacology

Frontiers in Pharmacology, 2023
As a potential drug candidate for the treatment of hypertension and complications, it is speculated that the component-based Chinese medicine of Ginkgo biloba leaves (GBCCM) which mainly composed of flavonoid aglycones (FAs) and terpene lactones (TLs ...
Hongbao Liang, Hongbao Liang, Hongbao Liang, Jingchun Yao, Jingchun Yao, Yu Miao, Yu Miao, Ying Sun, Ying Sun, Ying Sun, Yanbing Gao, Chenghong Sun, Chenghong Sun, Rui Li, Rui Li, He Xiao, He Xiao, Qun Feng, Qun Feng, Guofei Qin, Guofei Qin, Xiaoyan Lu, Xiaoyan Lu, Zhong Liu, Zhong Liu, Guimin Zhang, Guimin Zhang, Feng Li, Mingguo Shao   +28 more
doaj   +1 more source

Entry and Competition in the Pharmaceutical Market following Patent Expiry [PDF]

, 2011
This dissertation encompasses three essays on entry and competition in the German generic drug market. The first paper examines the market entry decisions of generic companies and finds that original drug producrs do not create barriers to entry by ...
Appelt, Silvia
core   +1 more source

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

Mechanistic modeling of generic orally inhaled drug products: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
In silico mechanistic modeling approaches have been designed by various stakeholders with the goal of supporting development and approval of generic orally inhaled drug products in the United States.
Ross L. Walenga, Clare Butler, Brent A. Craven, P. Worth Longest, Raja Mohamed, Bryan Newman, Bo Olsson, Günther Hochhaus, Bing V. Li, Markham C. Luke, Liang Zhao, Andrzej Przekwas, Robert Lionberger   +12 more
doaj   +1 more source

Model Master File Framework: A Regulatory Path Advancing Modeling and Simulation Applications

Clinical and Translational Science
To advance drug product development, regulatory decision making, and improve patient care, FDA has committed to the quantitative medicine paradigm that involves, among others, quantitative in silico methodologies and tools developed based on nonclinical,
Eleftheria Tsakalozou, Rachel Erdman, Lei Zhang, Robert Lionberger, Lanyan Fang   +4 more
doaj   +1 more source

Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance

EClinicalMedicine, 2021
Background: Over the past decade, U.S. FDA has approved 10 opioid analgesics in abuse-deterrent formulations (ADFs). ADFs are intended to reduce abuse of a prescription opioid through manipulation of the product to use one or more routes of abuse ...
Liang Zhao, Zhichuan Li, Lanyan Fang, Myong-Jin Kim, Srikanth C. Nallani, Chandrahas G. Sahajwalla, Silvia N. Calderon, Rigoberto A. Roca, Kairui Feng, Issam Zineh, Robert Lionberger   +10 more
doaj   +1 more source

Microbiome−host proteostasis crosstalk—An emerging perspective on mechanisms and interventions toward healthy longevity

FEBS Letters, EarlyView.
Proteostasis and the gut microbiota play a key role in shaping host physiology. Microbiota‐derived metabolites, vitamins, and RNA modulate host proteostasis. Findings from model systems, including C. elegans, indicate microbes can either stabilize or disrupt host proteostasis.
Abhishek Anil Dubey, Maria Ermolaeva
wiley   +1 more source

Advances in brain-targeted delivery strategies and natural product-mediated enhancement of blood–brain barrier permeability

Journal of Nanobiotechnology
The blood–brain barrier (BBB) represents a formidable challenge in the treatment of neurological disorders, as it restricts the passage of most therapeutic agents into the central nervous system (CNS).
Suyi Liu, Xingyue Jin, Yuanyuan Ge, Junlin Dong, Xinyue Liu, Xiao Pei, Ping Wang, Bing Wang, Yanxu Chang, Xie-an Yu   +9 more
doaj   +1 more source

GENERIC DRUGS MARKET: BRAND VERSUS GENERIC [PDF]

, 2013
A generic drug is a product that is comparable to brand/reference listed drug product in dosage form, potency, route of administration, quality and intended use.
Badjatya, Jitendra Kumar
core   +1 more source

Microbiome‐blood–brain barrier interactions in aging — mechanisms and therapeutic potential

FEBS Letters, EarlyView.
Aging reshapes the gut microbiome (↓SCFA‐producing commensals; ↑pro‐inflammatory outputs), shifting circulating metabolites (↓SCFAs; ↑LPS, ↑TMAO, ↑PAA) that act at the BBB to increase nonspecific transcytosis, alter transport, and promote astrocyte reactivity, heightening brain vulnerability.
Daniel Cuervo‐Zanatta, Hari Baskar Balasubramanian, Amir Pasokh, Marietta Zille   +3 more
wiley   +1 more source