Scientific and regulatory activities initiated by the U.S. food and drug administration to foster approvals of generic dry powder inhalers: Quality perspective.

Administration, Inhalation Drugs, Generic Dry Powder Inhalers Humans Metered Dose Inhalers Powders United States United States Food and Drug Administration
Abbreviated new drug application Critical quality attributes Inhalation Powder Quality

Journal

Advanced drug delivery reviews
ISSN: 1872-8294
Titre abrégé: Adv Drug Deliv Rev
Pays: Netherlands
ID NLM: 8710523

Informations de publication

Date de publication:
10 2022
Historique:
received: 01 06 2022
revised: 18 08 2022
accepted: 22 08 2022
pubmed: 30 8 2022
medline: 28 9 2022
entrez: 29 8 2022
Statut: ppublish

Résumé

Regulatory science for generic dry powder inhalation products worldwide has evolved over the last decade. The revised draft guidance Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations [1] (Revision 1, April 2018) that FDA issued summarizes product considerations and potential critical quality attributes (CQAs). This guidance emphasizes the need to apply the principles of quality by design (QbD) and elements of pharmaceutical development discussed in the International Conference for Harmonisation of (ICH) guidelines. Research studies related to quality were used to support guidance recommendations, which preceded the first approval of a generic DPI product in the U.S. This review outlines scientific and regulatory hurdles that need to be surmounted to successfully bring a generic DPI to the market. The goal of this review focuses on relevant issues and various challenges pertaining to CMC topics of the generic DPI quality attributes. Furthermore, this review provides recommendations to abbreviated new drug application (ANDA) applicants to expedite generic approvals.

Identifiants

DOI: 10.1016/j.addr.2022.114519 PMID: 36038083
pubmed: 36038083
pii: S0169-409X(22)00409-4
doi: 10.1016/j.addr.2022.114519
pii:
doi:

Substances chimiques

Drugs, Generic 0
Powders 0

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

114519

Informations de copyright

Published by Elsevier B.V.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Nashwa El-Gendy (N)

Division of Immediate and Modified Release Drug Products III, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Craig M Bertha (CM)

Division of New Drug Products II, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Mohammed Abd El-Shafy (M)

Division of Immediate and Modified Release Drug Products III, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Dhaval K Gaglani (DK)

Division of Immediate and Modified Release Drug Products III, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Andrew Babiskin (A)

Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Elizabeth Bielski (E)

Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Susan Boc (S)

Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Sneha Dhapare (S)

Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Lanyan Fang (L)

Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Katharine Feibus (K)

Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Anubhav Kaviratna (A)

Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Bing V Li (BV)

Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Markham C Luke (MC)

Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Tian Ma (T)

Division of Bioequivalence I, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Bryan Newman (B)

Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Michael Spagnola (M)

Division of Clinical Safety and Surveillance, Office of Safety and Clinical Evaluation, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Ross L Walenga (RL)

Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Electronic address: Ross.Walenga@fda.hhs.gov.

Liang Zhao (L)

Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

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Classifications MeSH

questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Voies d'administration de substances chimiques et des médicaments › Administration par inhalation › Scientific and regulatory activities initiated...
questionsmedicales.fr › Préparations pharmaceutiques › Médicaments génériques › Scientific and regulatory activities initiated...
questionsmedicales.fr › Équipement et fournitures › Nébuliseurs et vaporisateurs › Inhalateurs à poudre sèche › Scientific and regulatory activities initiated...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Scientific and regulatory activities initiated...
questionsmedicales.fr › Équipement et fournitures › Nébuliseurs et vaporisateurs › Aérosols-doseurs › Scientific and regulatory activities initiated...
questionsmedicales.fr › Préparations pharmaceutiques › Poudres › Scientific and regulatory activities initiated...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › Scientific and regulatory activities initiated...
questionsmedicales.fr › Organisations et économie des soins de santé › Organismes › Gouvernement › Agences gouvernementale américaines › Department of Health and Human Services (USA) › Public Health Service (USA) › Food and Drug Administration (USA) › Scientific and regulatory activities initiated...