المؤلفون: Martin A. Hofsäss, Jennifer B. Dressman

المصدر: Journal of Pharmaceutical Sciences. 108:2824-2837

مصطلحات موضوعية: Computer science, Biological Availability, Pharmaceutical Science, Guidelines as Topic, Equivalence Trials as Topic, 02 engineering and technology, Class iii, World Health Organization, Models, Biological, Risk Assessment, 030226 pharmacology & pharmacy, Essential medicines, World health, Biopharmaceutics, Discriminatory power, 03 medical and health sciences, 0302 clinical medicine, Drugs, Generic, Computer Simulation, Regulatory science, European Union, Drug Approval, Essential drugs, United States Food and Drug Administration, Management science, Guidance documents, 021001 nanoscience & nanotechnology, Biopharmaceutics Classification System, United States, Therapeutic Equivalency, Drugs, Essential, 0210 nano-technology

الوصف: This article summarizes historic developments, recent expert opinions, and (currently) unresolved challenges concerning the Biopharmaceutics Classification System (BCS)-based Biowaiver. An overview of approval statistics and application potential, case examples addressing the discriminatory power of the procedure, as well as an outlook on possible refinements in the future are provided and critically discussed. Over the last decade, regulatory guidance documents have been harmonized, for example, following scientific consent on allowing biowaivers for BCS class III drugs, making over 50% of orally administered drugs on the World Health Organization Essential Medicines List eligible for an abbreviated approval. Biowaiver monographs that present a complete risk-benefit evaluation for individual drugs have been issued by the International Pharmaceutical Federation for more than 25% of those drugs with the long-range aim of covering all essential drugs. Unresolved issues that have emerged from reported examples of false-negative and false-positive outcomes in the literature demand further adjustments to the regulatory requirements. Possible solutions for resolving these issues are the use of modeling and simulation and refined biorelevant in vitro tests that are better able to discriminate between dosage forms with unequal performance in vivo, potentially allowing biowaivers for selected BCS II drugs.

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::948dc31c7451ad8164aa62b27aef0c29
https://doi.org/10.1016/j.xphs.2019.04.030

المؤلفون: Sagar B Dugani, Kishor M. Wasan, Niranjan Kissoon

المصدر: Journal of pharmaceutical sciences. 107(5)

مصطلحات موضوعية: Adult, medicine.medical_specialty, Pharmaceutical Science, Disease, 030204 cardiovascular system & hematology, Global Health, World Health Organization, Communicable Diseases, Essential medicines, World health, 03 medical and health sciences, 0302 clinical medicine, Acquired immunodeficiency syndrome (AIDS), Thromboembolism, medicine, Global health, Humans, Thromboembolic disease, 030212 general & internal medicine, Musculoskeletal Diseases, Child, business.industry, Mental Disorders, medicine.disease, Mental health, Clinical trial, Cardiovascular Diseases, Family medicine, business, Drugs, Essential

الوصف: In June 2017, the World Health Organization released 20th Model List of Essential Medicines for adults and sixth Model List of Essential Medicines for children. In our commentary, we describe the changes to the Essential Medicine list, and identify deficits in excluding medicines for management of diseases with a high burden. In using tracer conditions such as cardiovascular and thromboembolic disease, mental health, and diseases of the musculoskeletal system, we highlight the absence of several medicines, which are incorporated into major clinical practice guidelines. We recommend that the World Health Organization review its process with respect to identifying disease conditions as well as evidence-based therapies.

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b983af8028e437eb08c47b69905ac271
https://pubmed.ncbi.nlm.nih.gov/29277641