PMID- 22918857
OWN - NLM
STAT- MEDLINE
DCOM- 20121113
LR  - 20151119
IS  - 0004-4172 (Print)
IS  - 0004-4172 (Linking)
VI  - 62
IP  - 9
DP  - 2012 Sep
TI  - Development of a subcutaneous formulation for trastuzumab - nonclinical and 
      clinical bridging approach to the approved intravenous dosing regimen.
PG  - 401-9
LID - 10.1055/s-0032-1321831 [doi]
AB  - A subcutaneous (SC) formulation has been developed for the humanized monoclonal 
      antibody (mAb) trastuzumab as an alternative to established intravenous (IV) 
      infusion. The ready-to-use liquid SC formulation is injected as a fixed dose in 
      approximately 5 min, which is expected to increase patient's convenience, reduce 
      pharmacy preparation time, and administration costs overall.The trastuzumab dose 
      as well as the dose of recombinant human hyaluronidase (rHuPH20), an enzyme that 
      enables SC administration of volumes larger than 2 mL, was selected based on 
      nonclinical xenograft, pharmacology, and pharmacokinetics mouse and minipig 
      studies.The basic assumption for bridging from the IV to the SC regimen was that 
      comparable trastuzumab serum trough concentrations would result in comparable 
      efficacy. This hypothesis is confirmed by the results from the Phase 3 study in 
      the neo-adjuvant/adjuvant setting. The safety profiles of the trastuzumab SC and 
      IV formulations are comparable and consistent with the known safety profile of 
      trastuzumab.
CI  - (c) Georg Thieme Verlag KG Stuttgart . New York.
FAU - Bittner, B
AU  - Bittner B
AD  - F. Hoffmann-La Roche Ltd., Clinical Pharmacology, Basel, Switzerland.
FAU - Richter, W F
AU  - Richter WF
FAU - Hourcade-Potelleret, F
AU  - Hourcade-Potelleret F
FAU - McIntyre, C
AU  - McIntyre C
FAU - Herting, F
AU  - Herting F
FAU - Zepeda, M L
AU  - Zepeda ML
FAU - Schmidt, J
AU  - Schmidt J
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20120823
PL  - Germany
TA  - Arzneimittelforschung
JT  - Arzneimittel-Forschung
JID - 0372660
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
EIN - Arzneimittelforschung. 2013 Nov;63(11):602
MH  - Animals
MH  - Antibodies, Monoclonal, Humanized/*administration & 
      dosage/*chemistry/pharmacokinetics
MH  - Antineoplastic Agents/administration & dosage/chemistry/pharmacokinetics
MH  - Chemistry, Pharmaceutical/*methods
MH  - Clinical Trials, Phase I as Topic
MH  - Clinical Trials, Phase III as Topic
MH  - Drug Evaluation, Preclinical
MH  - Humans
MH  - Hypodermoclysis
MH  - Injections, Subcutaneous
MH  - Trastuzumab
EDAT- 2012/08/25 06:00
MHDA- 2012/11/14 06:00
CRDT- 2012/08/25 06:00
PHST- 2012/08/25 06:00 [entrez]
PHST- 2012/08/25 06:00 [pubmed]
PHST- 2012/11/14 06:00 [medline]
AID - 10.1055/s-0032-1321831 [doi]
PST - ppublish
SO  - Arzneimittelforschung. 2012 Sep;62(9):401-9. doi: 10.1055/s-0032-1321831. Epub 
      2012 Aug 23.