Drug Product

Pharmaceutical product recall

Dr. John Campbell

Continuous Manufacturing of Drug Product (20of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

Drug Substance, Drug Products and Excipients

Generic Drug Product Quality Assessment (22of27) Generic Drugs Forum 2018

U.S. Food and Drug Administration

Biosimilars: Manufacturing and Inherent Variation

U.S. Food and Drug Administration

Facilitating Generic Drug Product Development through Product-Specific Guidances

U.S. Food and Drug Administration

Asymchem Drug Product Capabilities

Quality Considerations for Generic Orally Inhaled Drug Products (35of39) Complex Generics 2018

U.S. Food and Drug Administration

Procedure for export of pharmaceutical product | Technical documentation | DMF | CTD | eCTD | ACTD

DEPTH OF BIOLOGY

The ABC's of Formulation Development for Parenteral Drug Product Manufacturing

Berkshire Sterile

Benefit-Risk Considerations During Drug Product Development (8of14) REdI 2018

U.S. Food and Drug Administration

Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies

U.S. Food and Drug Administration

Drug Product Nomenclature (15of19) PDL – Dec.4-5, 2019

U.S. Food and Drug Administration

Product-Specific Guidances for Complex Generic Drugs

U.S. Food and Drug Administration

Samsung Biologics | Drug Product Manufacturing

Samsung Biologics

Referencing Approved Drug Products in ANDA Submissions (9of28) Generic Drugs Forum – Apr. 3-4, 2019

U.S. Food and Drug Administration

Modernizing Drug Substance Assessment through KASA

U.S. Food and Drug Administration

Roche Basel Drug Substance Manufacturing Site

QbD in Biologics Drug Product Development and Manufacturing

International Pharmaceutical Federation

Postmarketing Safety and Surveillance of Generic Drugs Update

U.S. Food and Drug Administration