Results 261 to 270 of about 31,268,655 (339)

Streamlining Food Effect Assessment — Are Repeated Food Effect Studies Needed? An IQ Analysis

AAPS Journal, 2023
Current regulatory guidelines on drug-food interactions recommend an early assessment of food effect to inform clinical dosing instructions, as well as a pivotal food effect study on the to-be-marketed formulation if different from that used in earlier ...
F. Kesisoglou, S. Basu, Tejashree Belubbi, Philip W. Bransford, John Chung, S. Dodd, M. Dolton, T. Heimbach, Priyanka Kulkarni, Wen Lin, Andrea Moir, N. Parrott, X. Pepin, Xiaojun Ren, Pradeep Sharma, K. Stamatopoulos, C. Tistaert, S. Vaidhyanathan, Christian Wagner, A. E. Riedmaier   +19 more
semanticscholar   +1 more source

Bio-enabling strategies to mitigate the pharmaceutical food effect: a mini review.

International journal of pharmaceutics, 2022
The concomitant administration of oral drugs with food can result in significant changes in bioavailability, leading to variable pharmacokinetics and considerable clinical implications, such as over- or under-dosing.
Tahlia R. Meola, K. Bremmell, Desmond B. Williams, H. B. Schultz, C. Prestidge   +4 more
semanticscholar   +1 more source

Understanding Mechanisms of Food Effect and Developing Reliable PBPK Models Using a Middle-out Approach

AAPS Journal, 2021
Over the last 10 years, 40% of approved oral drugs exhibited a significant effect of food on their pharmacokinetics (PK) and currently the only method to characterize the effect of food on drug absorption, which is recognized by the authorities, is to ...
X. Pepin, J. Huckle, R. Alluri, S. Basu, S. Dodd, N. Parrott, Arian Emami Riedmaier   +6 more
semanticscholar   +1 more source

Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models

AAPS Journal, 2021
Food can alter drug absorption and impact safety and efficacy. Besides conducting clinical studies, in vitro approaches such as biorelevant solubility and dissolution testing and in vivo dog studies are typical approaches to estimate a drug’s food effect.
Christian Wagner, F. Kesisoglou, X. Pepin, N. Parrott, Arian Emami Riedmaier   +4 more
semanticscholar   +1 more source

Tourist's satisfaction with local food effect behavioral intention in COVID-19 pandemic: a moderated-mediated perspective

British Food Journal, 2021
PurposeThis study explored the relationship between local food consumption value and satisfaction with local food, leading to behavioral intention. Moreover, tourist's involvement is used as a mediator, and COVID-19 fear moderates between satisfaction ...
S. ur Réhman, S. Samad, Sandeep Singh, Muhammad Usman   +3 more
semanticscholar   +1 more source

Oral formulation strategies to improve the bioavailability and mitigate the food effect of abiraterone acetate.

International journal of pharmaceutics, 2020
Abiraterone acetate, marketed as Zytiga®, is an antiandrogen medication used in the treatment of prostate cancer. Abiraterone acetate is a BCS Class IV compound associated with several oral delivery challenges.
H. B. Schultz, Tahlia R. Meola, Nicky Thomas, C. Prestidge   +3 more
semanticscholar   +1 more source

Effects of food processing on food allergens

Molecular Nutrition & Food Research, 2009
AbstractFood allergies are on the rise in Western countries. With the food allergen labeling requirements in the US and EU, there is an interest in learning how food processing affects food allergens. Numerous foods are processed in different ways at home, in institutional settings, and in industry.
Shridhar K, Sathe, Girdhari M, Sharma
openaire   +2 more sources

Physiologically Based Pharmacokinetic Modeling of Oral Absorption, pH, and Food Effect in Healthy Volunteers to Drive Alpelisib Formulation Selection

AAPS Journal, 2020
A physiologically based pharmacokinetic (PBPK) human model for alpelisib, an oral α-specific class I phosphatidylinositol-3-kinase (PI3K) inhibitor, was established to simulate oral absorption and plasma pharmacokinetics of healthy subjects to allow ...
M. Gajewska, Lars Blumenstein, A. Kourentas, M. Mueller-Zsigmondy, S. Lorenzo, Angela Sinn, M. Velinova, T. Heimbach   +7 more
semanticscholar   +1 more source

Can PBPK Modeling Streamline Food Effect Assessments?

Journal of clinical pharmacology, 2020
Physiologically based pharmacokinetic (PBPK) modeling is routinely used to study drug‐drug interactions, replace some dedicated clinical studies, and inform product labeling.
F. Kesisoglou
semanticscholar   +1 more source

Effects of food attributes on hunger and food intake

International Journal of Obesity, 2000
To explore the relative importance of a food's macronutrient composition, energy value, energy density, fiber content, weight, volume, sensory properties and rheology on hunger and food intake.Preloads of peanuts, peanut butter (rheology control), almonds (tree nut), chestnuts (macronutrient control), chocolate (sensory control), rice cakes (volume ...
S V, Kirkmeyer, R D, Mattes
openaire   +2 more sources