Results 31 to 40 of about 9,371 (163)

Bioequivalence of Topical Dermatological Dosage Forms – Methods of Evaluation of Bioequivalence [PDF]

Skin Pharmacology and Physiology, 1998
Peer Reviewed ; http://deepblue.lib.umich.edu/bitstream/2027.42/41463/1/11095_2004_Article_303794 ...
Shah, Vinod P., Bon, Charles, Kaplan, Stanley A., Yacobi, Avraham, Maibach, Howard I., Fleischer, Nicholas M., Franz, Thomas J., Kawamoto, Jeff, Marty, Jean-Paul, Lesko, Lawrence J., Wilkin, Jonathan, Pershing, Lynn K., Schaefer, Hans, Sequeira, Joel A., Shrivastava, Surendra P., Williams, Roger L., Flynn, Gordon L.   +16 more
openaire   +3 more sources

The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data.

PLoS ONE, 2019
BackgroundAffordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with ...
Warren A Kaplan, Jorge Cárdenas, Cristián Mansilla, Tatiana Tobar, Veronika J Wirtz   +4 more
doaj   +1 more source

The Emerging Threat of Antibiotic Residues in the Aquatic Environments of East Africa: A Systematic Review

Environmental Health Insights
Background: Antibiotic contamination of aquatic ecosystems, driven by poor waste management, is a critical public and environmental health concern in East Africa, though comprehensive regional data remain limited.
Duresa Dedefo, Gemmechu Hasen, Belachew Umeta, Desta Assefa, Yesuneh Tefera Mekasha, Simon Genet, Daniel Legese Achalu, Habtewold D. Waktola, Dereje Kebebe, Sileshi Belew, Sultan Suleman   +10 more
doaj   +1 more source

Nanocarriers based therapy and diagnosis of brain diseases: cross the blood-brain barrier

Science and Technology of Advanced Materials
The blood-brain barrier (BBB) is the protective interface that isolates the central nervous system from circulating blood, which restricts approximately 98% of small molecule drugs and nearly all large molecules from entering the brain.
Lijun An, Jinwei Zhang, Xiaobo Wang, Yuanyuan Ge, Kunhui Sun, Junlin Dong, Ping Wang, Wei Li, Meifang Li, Xuelei Hu, Bing Wang, Xie-An Yu   +11 more
doaj   +1 more source

Generic-reference and generic-generic bioequivalence of forty-two, randomly-selected, on-market generic products of fourteen immediate-release oral drugs

BMC Pharmacology and Toxicology, 2017
Background The extents of generic-reference and generic-generic average bioequivalence and intra-subject variation of on-market drug products have not been prospectively studied on a large scale.
Muhammad M. Hammami, Sophia J. S. De Padua, Rajaa Hussein, Eman Al Gaai, Nesrine A. Khodr, Reem Al-Swayeh, Syed N. Alvi, Nada Binhashim   +7 more
doaj   +1 more source

Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects

BMC Medical Research Methodology
Background This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017.
Turki A. Althunian, Bader R. Alzenaidy, Raseel A. Alroba, Ohoud A. Almadani, Fahad A. Alqahtani, Albatool A. Binajlan, Amal I. Almousa, Deema K. Alamr, Malak S. Al-Mofada, Nora Y. Alsaqer, Hessa A. Alarfaj, Abdulmohsen A. Bahlewa, Mohammed A. Alharbi, Ali M. Alhomaidan, Abdulaziz A. Alsuwyeh, Abdulmohsen A. Alsaleh   +15 more
doaj   +1 more source

An encounter between metal ions and natural products: natural products-coordinated metal ions for the diagnosis and treatment of tumors

Journal of Nanobiotechnology
Natural products-coordinated metal ions to form the nanomedicines are in the spotlight for cancer therapy. Some natural products could be coordinated with metal ions forming nanomedicines via simple and green environmental self-assembly, which not only ...
Xinyue Liu, Suyi Liu, Xingyue Jin, Haifan Liu, Kunhui Sun, Xiongqin Wang, Meifang Li, Ping Wang, Yanxu Chang, Tiejie Wang, Bing Wang, Xie-an Yu   +11 more
doaj   +1 more source

Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook

Pharmaceuticals
Bioequivalence studies are pivotal in generic drug development wherein therapeutic equivalence is provided with an innovator product. However, bioequivalence studies represent significant complexities due to the interplay of multiple factors related to ...
Sivacharan Kollipara, Frederico Severino Martins, Rebeka Jereb, Dejan Krajcar, Tausif Ahmed   +4 more
doaj   +1 more source

Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability

Journal of Probability and Statistics, 2015
For approval of generic drugs, the FDA requires that evidence of bioequivalence in average bioequivalence in terms of drug absorption be provided through the conduct of a bioequivalence study.
Jianghao Li, Shein-Chung Chow
doaj   +1 more source

Ayurvedic herbal formulations Haridra Khanda and Manjisthadi Kwath (brihat) in the management of allergic rhinitis: A pharmacological study

Heliyon
This study aims to pharmacologically validate Haridra Khanda (HK) and Manjishthadi Kwatham (brihat) (MMK) in allergy management using invivo and invitro studies to rationalize the prescription of these two ayurvedic polyherbal drug formulations, which ...
Rudranil Bhowmik, Md Adil Shaharyar, Mahibub Mahamadsa Kanakal, Arnab Sarkar, Syeda Ayesha Farhana, Shalam M. Hussain, Abdullah Khan, Pallab Mandal, S. Roshan, Achintya Mitra, Sanmoy Karmakar   +10 more
doaj   +1 more source