Classification system proposed to guide the design, development, regulatory approval, and scaling of long acting, small- and macro-molecule parenteral products (CS-BLAP)

Long acting (LA) drug products extend the effect of a single dose for weeks or months, offering new options for disease prevention and treatment. However, regulatory guidance on LA drug product development and equivalence remains limited. The existing Biopharmaceutics Classification System (BCS) gui...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2026-02, Vol.115 (2), p.104056, Article 104056
Main Authors: Perazzolo, Simone, Shen, Danny D., Ho, Rodney J.Y.
Format: Article
Language:English
Subjects:
Absorption
ADME
Bioequivalence
Biological Products - administration & dosage
Biological Products - classification
Biologics
Biopharmaceutics - methods
Classification system
CS-BLAP
Delayed-Action Preparations - administration & dosage
Delayed-Action Preparations - classification
Drug Approval
Drug Delivery Systems
Drug Design
Drug Development - methods
Humans
Injectables
Long-acting injectables
Long-acting medicine
Lymphatic
Particle Size
Pharmaceutical Preparations - administration & dosage
Pharmaceutical Preparations - chemistry
Pharmaceutical Preparations - classification
Pharmacokinetics
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