Results 71 to 80 of about 781 (182)

Consideration on Food Effect Studies for Anticancer Drugs Approved in Japan Between 2001 and 2022

Clinical and Translational Science, Volume 18, Issue 7, July 2025.
ABSTRACT In developing a new drug, studies to evaluate the food effect (FE) on the drug's pharmacokinetics (FE studies) are generally conducted in healthy subjects in the early stages of clinical development. Conversely, for anticancer drugs, which have many adverse effects, it is assumed that FE studies cannot be conducted in healthy subjects. However,
Maho Shibuya, Hayataka Kubota, Hideki Maeda   +2 more
wiley   +1 more source

Current Use of Physiologically Based Pharmacokinetic modeling in New Medicinal Product Approvals at EMA

Clinical Pharmacology &Therapeutics, Volume 117, Issue 3, Page 808-817, March 2025.
Physiologically Based Pharmacokinetic (PBPK) Models are routinely used in drug development and therefore appear frequently in marketing authorization applications (MAAs) to the European Medicines Agency (EMA). For a model to be a key source of evidence for a regulatory decision, it must be considered qualified for the intended use.
Polly Paul, Pieter J. Colin, Flora Musuamba Tshinanu, Carolien Versantvoort, Efthymios Manolis, Kevin Blake   +5 more
wiley   +1 more source

Comparison of WHO and US FDA biowaiver dissolution test conditions using bioequivalent doxycycline hyclate drug products

, 2009
Objectives The dissolution characteristics of immediate-release doxycycline hyclate products with certified in-vivo bioequivalence to the innovator product were tested with a view to possible application of biowaiver-based approval.
Stefanie Strauch, Ekarat Jantratid, Jennifer B Dressman   +2 more
core   +1 more source

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate

, 2022
S.2-13Sitagliptin is an antihyperglycemic drug used in adults for the treatment of diabetes Type 2. Literature data and in-house experiments were applied in this monograph to assess whether methods based on the Biopharmaceutics Classification System (BCS)
Mehta, M., Abrahamsson, B., Tajiri, T., Bakheit, A.A., Haque, K.U., Langguth, P., Dressman, J., Parr, A., Shah, V.P., Charoo, N.A., Polli, J.E., Abdallah, D.B., Cristofoletti, R., Hassan, H.A.   +13 more
core   +1 more source

Development of in vitro - in vivo correlations for newly optimized Nimesulide formulations. [PDF]

PLoS ONE, 2018
Use of the human volunteers in bioequivalence studies is being discouraged by the Food and drug administration after the introduction of biowaiver approaches.
Muhammad Hanif, Muhammad Harris Shoaib, Rabia Ismail Yousuf, Farya Zafar   +3 more
doaj   +1 more source

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron.

, 2019
Literature data pertaining to the physicochemical, pharmaceutical, and pharmacokinetic properties of ondansetron hydrochloride dihydrate are reviewed to arrive at a decision on whether a marketing authorization of an immediate release (IR) solid oral ...
Langguth, Peter, Belubbi, Tejashree, Shah, Vinod P, Rajawat, Gopal Singh, Cristofoletti, Rodrigo, Groot, Dirk W, Tajiri, Tomokazu, Dressman, Jennifer, Nagarsenker, Mangal S, Parr, Alan, Abrahamsson, Bertil, Mehta, Mehul, Polli, James E   +12 more
core   +1 more source

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride

, 2023
893903Levocetirizine, a histamine H1-receptor antagonist, is prescribed to treat uncomplicated skin rashes associated with chronic idiopathic urticaria as well as the symptoms of both seasonal and continual allergic rhinitis.
Langguth, Peter, Charoo, Naseem Ahmad, Abdallah, Daud Baraka, Abrahamsson, Bertil S.I., Polli, James E., Shah, Vinod P., Ahmed, Daoud T., Cristofoletti, Rodrigo, Mehta, Mehul U., Parr, Alan F., Kambayashi, Atsushi, Dressman, Jennifer Joy   +11 more
core   +1 more source

Open questions on bioequivalence: the case of cholecalciferol

Italian Journal of Medicine, 2013
Cholecalciferol or vitamin D3 is an endogenous substance with the typical problems of bioavailability/bioequivalence of this class of substances. A previous trial has shown that, if administered orally at a dose of 800-10,000 IU and bioassayed as its 25 ...
Antonio Marzo, Anna Barassi, Elisabetta Porro   +2 more
doaj   +1 more source

In Vitro Comparative Quality Assessment of Different Brands of Doxycycline Hyclate Finished Dosage Forms: Capsule and Tablet in Jimma Town, South-West Ethiopia

Advances in Pharmacological and Pharmaceutical Sciences, 2021
Background. Persistent postmarket quality evaluation helps produce clear information on the current quality status of the different brands of a given drug and hence introduces a biopharmaceutical and therapeutically equivalent list of the products to the
Woldemichael Abraham, Habtamu Abuye, Selass Kebede, Sultan Suleman   +3 more
doaj   +1 more source

Development and comparison of model‐integrated evidence approaches for bioequivalence studies with pharmacokinetic end points

CPT: Pharmacometrics &Systems Pharmacology, Volume 13, Issue 10, Page 1734-1747, October 2024.
Abstract By applying nonlinear mixed‐effect (NLME) models, model‐integrated evidence (MIE) approaches are able to analyze bioequivalence (BE) data with pharmacokinetic end points that have sparse sampling, which is problematic for non‐compartmental analysis (NCA).
Xiaomei Chen, Henrik B. Nyberg, Mark Donnelly, Liang Zhao, Lanyan Fang, Mats O. Karlsson, Andrew C. Hooker   +6 more
wiley   +1 more source