المؤلفون: Dina Al-Numani, Philippe Colucci, Murray P. Ducharme

المصدر: Asian Journal of Pharmaceutical Sciences, Vol 10, Iss 6, Pp 461-471 (2015)

مصطلحات موضوعية: Inhalation products, Pharmacokinetics, Pharmacodynamics, Bioequivalence, Therapeutic equivalence, Clinical endpoint studies, Therapeutics. Pharmacology, RM1-950

الوصف: Orally inhaled drug products (OIPs), such as corticosteroids and bronchodilators, are at the forefront of asthma and chronic obstructive pulmonary disease treatments, two diseases that afflict worldwide populations. Introducing generics of these products is essential, as the pricing of these medications remain a barrier to adequate patient care. Currently, there is no consensus between regulatory bodies as to the bioequivalence and equivalence requirements of OIPs that are intended for local action in the lungs. This manuscript critically reviews these requirements and presents future directions for clinicians, scientists, and regulators to consider to optimize the development and approval of OIPs.

وصف الملف: electronic resource

العلاقة: http://www.sciencedirect.com/science/article/pii/S1818087615000677Test; https://doaj.org/toc/1818-0876Test

الوصول الحر: https://doaj.org/article/c64b047788064748b383cb060f3f0c15Test

المؤلفون: Philippe Colucci, Dina Al-Numani, Murray P. Ducharme

المصدر: Asian Journal of Pharmaceutical Sciences, Vol 10, Iss 6, Pp 461-471 (2015)

مصطلحات موضوعية: Pharmacology, medicine.medical_specialty, business.industry, lcsh:RM1-950, Inhalation products, Inhaled drug, Pharmaceutical Science, Pulmonary disease, Bioequivalence, medicine.disease, Patient care, lcsh:Therapeutics. Pharmacology, Pharmacodynamics, medicine, Clinical endpoint studies, Pharmacokinetics, Therapeutic equivalence, Intensive care medicine, business, Equivalence (measure theory), Asthma

الوصف: Orally inhaled drug products (OIPs), such as corticosteroids and bronchodilators, are at the forefront of asthma and chronic obstructive pulmonary disease treatments, two diseases that afflict worldwide populations. Introducing generics of these products is essential, as the pricing of these medications remain a barrier to adequate patient care. Currently, there is no consensus between regulatory bodies as to the bioequivalence and equivalence requirements of OIPs that are intended for local action in the lungs. This manuscript critically reviews these requirements and presents future directions for clinicians, scientists, and regulators to consider to optimize the development and approval of OIPs.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d562330ec84d41b5dcaaa54ede6956d5Test
https://doi.org/10.1016/j.ajps.2015.08.006Test

المؤلفون: Al-Numani, Dina, Colucci, Philippe, Ducharme, Murray P.

المصدر: Asian Journal of Pharmaceutical Sciences; 2015, Vol. 10 Issue 6, p461-471, 11p

مصطلحات موضوعية: THERAPEUTIC equivalency in drugs, INHALATION administration, DRUG delivery systems, ADRENOCORTICAL hormones, BRONCHODILATOR agents, OBSTRUCTIVE lung diseases

مستخلص: Orally inhaled drug products (OIPs), such as corticosteroids and bronchodilators, are at the forefront of asthma and chronic obstructive pulmonary disease treatments, two diseases that afflict worldwide populations. Introducing generics of these products is essential, as the pricing of these medications remain a barrier to adequate patient care. Currently, there is no consensus between regulatory bodies as to the bioequivalence and equivalence requirements of OIPs that are intended for local action in the lungs. This manuscript critically reviews these requirements and presents future directions for clinicians, scientists, and regulators to consider to optimize the development and approval of OIPs. [ABSTRACT FROM AUTHOR]

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