Stability and stabilization studies of TAK-599 (ceftaroline fosamil), a novel N-phosphono type prodrug of anti-methicillin resistant Staphylococcus aureus …

Y Ikeda, J Ban, T Ishikawa, S Hashiguchi… - Chemical and …, 2008 - jstage.jst.go.jp
TAK-599 (known as ceftaroline fosamil) is a novel N-phosphono type prodrug of a
cephalosporin compound, T-91825, that exhibits strong activity against methicillin resistant …

[BOOK][B] Good pharmaceutical manufacturing practice: rationale and compliance

J Sharp - 2004 - taylorfrancis.com
With over twenty different official regulatory statements worldwide on Good Manufacturing
Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the …

[PDF][PDF] Product development issues of powders for injection

AK Bansal - Pharmaceutical technology, 2002 - researchgate.net
Powders for injection (PIs) are a popular parenteral dosage form for drugs that cannot be
marketed as ready-to-use injectables because of their instability in an aqueous environment …

Sterilization and Aseptic Processing

J Agalloco, J Akers - … Science and Technology, Six Volume Set …, 2013 - api.taylorfrancis.com
The administration of parenteral drugs is associated with an expectation for sterility of the
materials involved. In actuality, the real desire is for safety, as we also expect these products …

新規抗生物質 E1040 の固体安定性と製剤化研究について

芦澤一英, 内川清彦, 服部禎一, 石橋泰雄… - YAKUGAKU …, 1990 - jstage.jst.go.jp
抄録 In designing the dosage form, one major factor controling their physicochemical
properties is solid forms of the drug powder. The method for improving the physicochemical …

[CITATION][C] Validation of sterile products

MJ Akers, NR Anderson - Drugs and the pharmaceutical …, 1993 - pascal-francis.inist.fr
Validation of sterile products CNRS Inist Pascal-Francis CNRS Pascal and Francis
Bibliographic Databases Simple search Advanced search Search by classification Search …

[CITATION][C] FDA Regulatory

RF Tetzlaff - Aseptic Pharmaceutical Manufacturing …, 1987 - Interpharm Press Incorporated

[CITATION][C] An Introduction to

G Prout - Aseptic Pharmaceutical Manufacturing …, 1987 - Interpharm Press Incorporated