Results 41 to 50 of about 280,132 (308)

Medulloblastoma: Immune microenvironment and targeted nano-therapy

open access: yesOpenNano, 2022
The tumor microenvironment (TME) plays key roles in tumor development, progressive and metastasis. Recently, therapy strategies based on TME targeted modulation shows potential to improve the efficacy of therapeutics, which attracted much attention in ...
Qiyue Wang, Ji Liu
doaj   +1 more source

Profil Disolusi Terbanding Tablet Rifampisin Merek Dan Generik [PDF]

open access: yes, 2010
This time many of people still to contemn of generic drugs because they regard as quality of generic drugs low more than trademark drugs. This research was proposed to compare dissolution profile of rifampicine tablets trademark (A, B, C) and generic (C,
Kusuma, A. M. (Anjar)   +2 more
core   +2 more sources

Development of a Synthetic Hydrogel to Foster Microvascularization of an Endometriosis Microphysiological System

open access: yesAdvanced Healthcare Materials, EarlyView.
ABSTRACT The ascent of novel alternative methods in drug development spotlights the dual needs for improved biological fidelity to in vivo, along with reproducibility, especially in regulatory applications. The need for pre‐clinical models of patient‐derived endometriosis lesions motivates the development of a vascularizable, completely synthetic ...
Lauren Pruett   +7 more
wiley   +1 more source

A Tri‐Culture Heart‐on‐a‐Chip Platform With iPSC‐Derived Cardiac Cells for Predictive Cardiotoxicity Testing

open access: yesAdvanced Healthcare Materials, EarlyView.
This study presents the first entirely isogenic heart‐on‐chip, unifying cardiomyocytes, fibroblasts, and endothelial cells from a single iPSC source. The platform reveals a critical biological insight: the endothelium actively shields cardiac tissue from drug‐induced toxicity, challenging the predictive accuracy of conventional, avascular models for ...
Karine Tadevosyan   +12 more
wiley   +1 more source

A survey of Top 200 Drugs—Inconsistent Practice of Drug Strength Expression for Drugs Containing Salt Forms [PDF]

open access: yes, 2012
Many ionizable drugs are developed and marketed as salt forms. However, there are no clear US regulatory guidelines on drug strength labeling for salts. The strengths of some drugs are expressed as salts and some as free acids/bases.
Prohotsky, Daniel, Zhao, Fang
core   +2 more sources

Plant‐Produced Viral Nanoparticles Decorated with Nanobodies Against HER2 Improve Retention and Recruitment of Immune Cells in Solid Tumors

open access: yesAdvanced Healthcare Materials, EarlyView.
Potato virus X is a filamentous RNA plant virus that can be engineered into a molecular tool for cancer therapy. We produced genetically‐encoded virus‐derived nanoparticles decorated with nanobodies targeting cancer cell receptors, epidermal growth factor receptor (EGFR) and human epidermal growth factor 2 (HER2).
Enrique Lozano‐Sanchez   +4 more
wiley   +1 more source

Standardizing bioequivalence administration methods for chewable tablets: aligning product-specific guidance with current FDA recommendations

open access: yesAAPS Open
This paper examines the standardization of bioequivalence (BE) administration methods for chewable tablets and other dosage forms instructing chewing in alignment for generic drug development.
Hye Lim Lim   +4 more
doaj   +1 more source

In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2019
The development of generic, single‐entity, drug–device combination products for orally inhaled drug products is challenging in part because of the complex nature of device design characteristics and the difficulties associated with establishing ...
Ross L. Walenga   +2 more
doaj   +1 more source

Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

open access: yesCPT: Pharmacometrics & Systems Pharmacology, 2023
This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the US Food and Drug ...
Fang Wu   +17 more
doaj   +1 more source

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

open access: yesClinical 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.   +6 more
openaire   +3 more sources

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