title: Strategies of bringing drug product marketing applications to meet current regulatory standards.
abstract: In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.
authors.affiliation: Merck & Co., Kenilworth, New Jersey, USA, yan_wu@merck.com.
authors.forename: Yan
authors.initials: Y
authors.lastname: Wu
authors.forename: Anita
authors.initials: A
authors.lastname: Freed
authors.forename: David
authors.initials: D
authors.lastname: Lavrich
authors.forename: Ramesh
authors.initials: R
authors.lastname: Raghavachari
authors.forename: Kim
authors.initials: K
authors.lastname: Huynh-Ba
authors.forename: Ketan
authors.initials: K
authors.lastname: Shah
authors.forename: Mark
authors.initials: M
authors.lastname: Alasandro
mesh_terms: D017408:Guidelines as Topic; D040541:Marketing; D004364:Pharmaceutical Preparations
chemical_list: D004364:Pharmaceutical Preparations