Description
Inhaled Pharmaceutical Product Development Perspectives
Challenges and Opportunities
Emerging Issues in Analytical Chemistry Series
Author: Hickey Anthony J.
Language: EnglishSubject for Inhaled Pharmaceutical Product Development Perspectives:
Keywords
Abbreviated New Drug Application (ANDA); Aerodynamic particle size distribution; Aerosol behavior; Aerosol characteristics; Animal models; Cell culture; Cosolvent; Delivered dose; Disease targets; Dosage formulations; Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman); Drug aerosol; Drug delivery devices; Drug development; Drug route of administration; Dry powder inhalers; Dry powder inhalers (DPIs); In vitro-in vivo correlation (IVIVC); Inhaled pharmaceuticals; Investigational New Drug (IND) Application; Lung deposition imaging; Lung deposition modeling; Metered dose inhalers; Nebulizers; New Drug Application (NDA); Orally inhaled drug products (OIDPs); Particle metered dose inhalers; Pharmacodynamics; Pharmacokinetics; Physicochemical properties; Pressurized metered dose inhalers; Pressurized metered dose inhalers (pMDIs); Product development; Propellant; Quality by design (QbD); Quality control; Soft mist inhalers (SMIs); Soft mist sprays; Surfactant; US Food and Drug Administration (FDA); Weight of evidence
Support: Print on demand
Description
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Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product.
The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate formulation and device design, development, regulatory compliance, and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future.
Pharmaceutical scientists, formulation scientists, analytical chemists in the pharmaceutical sciences, regulatory officers, medical practitioners, patients and health scientists, graduate level pharmaceutical sciences students
- Discusses development strategies and best practices in the context of regulatory requirements
- Written by a broadly qualified expert drawing on the knowledge and critical opinions of key individuals in the field
- Includes a foreword by Charles G. Thiel