Drug product design

Food and Drug Laws that Affect Drug Product Design, Manufacture, and Distribution... 

Expiration Date—The date placed on the container label of a drug product designating the time before which a batch of the product is expected to remain within the approved shelf life specification, if stored under defined conditions, and after which it must not be used. 

Parenteral Dosage Forms. The most commonly used forms for drug products designed and manufactured for injection through the skin include those meant for subcutaneous, intramuscular, and intravenous administration. 

Table 1 Biopharmaceutic considerations in drug product design...

Martin, A. Swarbrick, J. Cammarata, A. Physical pharmacy and drug product design. In Physical Pharmacy, 3rd Ed. Lea Febiger Philadelphia, 1983 577-579. 

Searchable database of 4000 prescription and OTC drug products designed for the lay public. 

N. A. Peppas, Mathematical modelling of diffusion processes in drug delivery systems in Controlled Drug Bioavailability, Wiley, Vol. 1, Drug Product Design and Performance, V.F. Smolen, L.A. Ball, (Eds), 203, New York (1984). 

The FDA issued numerous TFMs for active ingredients found in OTC topical antimicrobial drug products described in the 1974 proposed notice of rule making. The TFM published in 1978 describes the tentative conclusions made by the Commissioner regarding the safety and efficacy requirements for OTC topical antimicrobial drug products designed for use by healthcare professionals in hospital-type settings. 

SUMMARY AND FUTURE OUTLOOK SYNTHONIC ENGINEERING PARTICLE PASSPORT AND THE FUTURE OF THE DRUG PRODUCT DESIGN... 

RepkaMA, Langley NA, DiNunzio J (2013) Melt extrusion materials, technology and drug product design. AAPS advances in the pharmaceutical sciences series, vol 9. Springer, New York Reverchon E, De Marco I, Delia Porta G (2002) Rifampicin microparticles production by supercritical antisolvent precipitation. Int J Pharm 243(l-2) 83-91... 

Repka MA, Langley NA, DiNunzio J (2013). Melt extrusion materials, technology and drug product design. AAPS press and Springer, New York... 

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