Results 61 to 70 of about 781 (182)

Effects of experimental conditions on solubility measurements for BCS classification in order to improve the biowaiver guidelines

Brazilian Journal of Pharmaceutical Sciences, 2021
Among the methods described for determining the solubility, shake-flask is suitable to evaluate the equilibrium solubility according to the BCS. Nevertheless, experimental conditions related to the shake-flask method are not well described.
Patrícia Fernanda Monteiro, Neila Márcia Silva-Barcellos, Tamires Guedes Caldeira, Adriana Cotta Cardoso Reis, Amanda Santos Ribeiro, Jacqueline de Souza   +5 more
doaj   +1 more source

A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme

Journal of Pharmacy & Pharmaceutical Sciences, 2021
The requirements to waive in vivo bioequivalence studies for immediate release solid oral dosage forms based on the Biopharmaceutics Classifications System (BCS) are well known, and biowaivers[1] for other types of oral dosage forms based on pre-defined ...
Alfredo Garcia Arieta, Craig Simon, Andrew Tam, Gustavo Mendes Lima Santos, Eduardo Agostinho Freitas Fernandes, Zulema Rodríguez Martínez, Clare Rodrigues, Sang Aeh Park, JaYoung Kim, Kwansoo Kim, Ryosuke Kuribayashi, Aya Myoenzono, Kohei Shimojo, Chantal Walther, Matthias S. Roost, Wen-Yi Hung, Li-feng Hsu, Christopher Crane, April C. Braddy, Joy van Oudtshoorn, Diego Alejandro Gutierrez Triana, Erwin Guzmán Aurela, Ben Jones, Henrike Potthast, Ivana Abalos   +24 more
doaj   +1 more source

Talazoparib Formulation Bridging in Cancer Patients—Challenges and the Critical Role of Model‐Informed Drug Development in Approval Despite Failed Bioequivalence

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 1, January 2026.
ABSTRACT Talazoparib is a poly(ADP‐ribose) polymerase inhibitor approved for the treatment of breast and prostate cancer. Commercialization of a soft gelatin capsule (SGC) formulation developed post‐approval required a bioequivalence (BE) and food effect (FE) study to bridge SGC with the initial commercial hard capsule (HC) formulation. Study execution
Diane Wang, Cathy Cen Guo, Xizhe Gao, Yibo Wang, Yanke Yu, Anna Plotka, Mohamed Elmeliegy, Haihong Shi, Samantha Johnson, Liza DeAnnuntis, Justin Hoffman   +10 more
wiley   +1 more source

Elucidating the Critical Role of Excipients in Gastric Emptying and Oral Absorption of a Rapidly Eliminated BCS I Drug: Implications from Zidovudine Bioequivalence

Pharmaceutics
Background/Objectives: Despite the presumption of bioequivalence for BCS Class I drugs due to their high solubility and permeability, recent evidence indicates that those with rapid systemic elimination exhibit heightened vulnerability to Cmax non ...
Yan Lin, Xian Zhang, Fulin Bi, Guangji Wang, Jin Yang   +4 more
doaj   +1 more source

Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities

Journal of Pharmaceutical Policy and Practice, 2018
Background The regulatory requirements for approval of generic medicines and the format of compiling drug dossiers vary among regulatory authorities.
D. Thambavita, P. Galappatthy, R. L. Jayakody   +2 more
doaj   +1 more source

Application of Gastrointestinal Simulation for Extensions for Biowaivers of Highly Permeable Compounds [PDF]

The AAPS Journal, 2008
The goal of this study was to apply gastrointestinal simulation technology and integration of physiological parameters to predict biopharmaceutical drug classification. GastroPlus was used with experimentally determined physicochemical and pharmacokinetic drug properties to simulate the absorption of several weak acid and weak base BCS class II ...
Marija, Tubic-Grozdanis, Michael B, Bolger, Peter, Langguth   +2 more
openaire   +2 more sources

Comprehensive Patterns Concerning BA/BE Studies and Biowaivers in the Regulatory Approval of Generic Pharmaceuticals in the United States, the EU, and India

Advances in Pharmacological and Pharmaceutical Sciences, Volume 2026, Issue 1, 2026.
This analysis studies the pharmaceutical approval policy regarding generics in the United States and European and Indian markets. Therapeutically equivalent generics are therefore considered safe, effective, and of comparable quality to their name‐brand counterparts.
Rakan Alsaqer, Ankitha M. S., Samathoti Prasanthi, Prakash Goudanavar, Mahesh Namballa, N. Raghavendra Naveen, Krishna Swaroop, Girish Meravanige, Nagaraja Sreeharsha, Afzal Haq Asif, Seema Saroj   +10 more
wiley   +1 more source

IN VITRO EQUIVALENCE STUDY OF GENERIC METFORMIN HYDROCHLORIDE TABLETS UNDER BIOWAIVER CONDITIONS [PDF]

, 2020
Background: Generic drugs are smarter alternative to expensive brands, it is bio- equivalent formula of any branded drug. FDA approved that generic drugs are the safest to consume, the medicines meet the similar manufacturing standards followed while ...
Soubra, Lama, D. Ajami, Rola, H. AL Arwadi, Ruaa, A. K. Gazy, Azza   +3 more
core   +1 more source

Evaluation of drug permeability methods recommended by health authorities

Medicine Science, 2020
The oral route is the most preferred route for drug administration because of patient compliance. Following oral administration, a drug has to cross several biological barriers before reaching the systemic circulation by transcellular or paracellular ...
Tugba Gulsun, Selma Sahin
doaj   +1 more source

The FDA Should Eliminate the Ambiguities in the Current BCS Biowaiver Guidance and Make Public the Drugs for Which BCS Biowaivers Have Been Granted [PDF]

Clinical Pharmacology & Therapeutics, 2010
Although US Food and Drug Administration (FDA)-approved Biopharmaceutics Classification System (BCS) class 1 drugs are designated as high-permeability drugs, in fact, the criterion utilized is high extent of absorption. This ambiguity should be eliminated, and the FDA criterion should explicitly be stated as > or =90% absorption based on absolute ...
L Z, Benet, C A, Larregieu
openaire   +2 more sources