PMID- 32107671
OWN - NLM
STAT- MEDLINE
DCOM- 20210126
LR  - 20210126
IS  - 1550-7416 (Electronic)
IS  - 1550-7416 (Linking)
VI  - 22
IP  - 2
DP  - 2020 Feb 27
TI  - Systematic Review of Device Parameters and Design of Studies Bridging 
      Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors.
PG  - 52
LID - 10.1208/s12248-020-0433-8 [doi]
AB  - Biologic-device combination products using prefilled syringes (PFSs) and 
      autoinjectors (AIs) are popular for biological products administered 
      subcutaneously. Pharmacokinetic (PK) comparability studies commonly provide the 
      scientific data to support introduction of AI presentations via bridging with 
      PFS. A survey of biological products approved by FDA's Center for Drug Evaluation 
      and Research identified 17 biologics license applications (BLAs) with both PFS 
      and AI presentations for subcutaneous (SC) administration, including 16 approved 
      on February 1, 2018, and one with AI presentation under review. A systematic 
      review on the device parameters and the PK comparability studies bridging the two 
      presentations was conducted. Subsequently, whether device parameters or the PK 
      study design may have influenced the PK comparability study results was 
      evaluated. The reported device parameters for AI and PFS are generally consistent 
      across BLAs, whereas the approach to assess PK comparability varied, including 
      the study design. Most PK comparability studies met bioequivalence (BE) criteria. 
      Upon inspection of the studies that did not meet BE criteria, injection depth of 
      AI and the injection site for either AI or PFS were identified as potential 
      influencing factors to the outcome of PK comparability study. This study 
      represents an initial attempt to identify the potential influencing factors on 
      device bridging, including the characteristics of the device and the clinical 
      pharmacology study. These findings may inform the combination product development 
      strategy, specifically design considerations for device and PK comparability 
      studies.
FAU - Hu, Ping
AU  - Hu P
AD  - Oak Ridge of Institute for Science and Education, Oak Ridge, Tennessee, USA.
AD  - Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. 
      Food and Drug Administration (OCP/CDER/FDA), 10903 New Hampshire Avenue, Silver 
      Spring, Maryland, 20993, USA.
FAU - Wang, Jie
AU  - Wang J
AD  - Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. 
      Food and Drug Administration (OCP/CDER/FDA), 10903 New Hampshire Avenue, Silver 
      Spring, Maryland, 20993, USA.
FAU - Florian, Jeffery
AU  - Florian J
AD  - Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. 
      Food and Drug Administration (OCP/CDER/FDA), 10903 New Hampshire Avenue, Silver 
      Spring, Maryland, 20993, USA.
FAU - Shatzer, Katherine
AU  - Shatzer K
AD  - Department of Pharmacology and Pharmaceutical Sciences, College of Pharmacy, 
      University of Houston, Houston, Texas, USA.
FAU - Stevens, Alan M
AU  - Stevens AM
AD  - Office of Device Evaluation, Center for Devices and Radiological Health, U.S. 
      Food and Drug Administration (ODE/CDRH/FDA), Silver Spring, Maryland, USA.
FAU - Gertz, Jacqueline
AU  - Gertz J
AD  - Office of Device Evaluation, Center for Devices and Radiological Health, U.S. 
      Food and Drug Administration (ODE/CDRH/FDA), Silver Spring, Maryland, USA.
FAU - Ji, Ping
AU  - Ji P
AD  - Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. 
      Food and Drug Administration (OCP/CDER/FDA), 10903 New Hampshire Avenue, Silver 
      Spring, Maryland, 20993, USA.
FAU - Huang, Shiew Mei
AU  - Huang SM
AD  - Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. 
      Food and Drug Administration (OCP/CDER/FDA), 10903 New Hampshire Avenue, Silver 
      Spring, Maryland, 20993, USA.
FAU - Zineh, Issam
AU  - Zineh I
AD  - Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. 
      Food and Drug Administration (OCP/CDER/FDA), 10903 New Hampshire Avenue, Silver 
      Spring, Maryland, 20993, USA.
FAU - Wang, Yow-Ming C
AU  - Wang YC
AD  - Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. 
      Food and Drug Administration (OCP/CDER/FDA), 10903 New Hampshire Avenue, Silver 
      Spring, Maryland, 20993, USA. Yowming.wang@fda.hhs.gov.
LA  - eng
PT  - Journal Article
PT  - Systematic Review
DEP - 20200227
PL  - United States
TA  - AAPS J
JT  - The AAPS journal
JID - 101223209
RN  - 0 (Biological Products)
SB  - IM
CIN - AAPS J. 2020 May 15;22(3):72. PMID: 32415524
MH  - Biological Products/*administration & dosage/*pharmacokinetics
MH  - Drug Compounding
MH  - Drug Delivery Systems/*instrumentation
MH  - Equipment Design
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Male
MH  - *Needles
MH  - *Syringes
MH  - Therapeutic Equivalency
MH  - Tissue Distribution
MH  - Viscosity
OTO - NOTNLM
OT  - PK comparability
OT  - injection site
OT  - prefilled syringe (PFS) and autoinjector (AI)
OT  - study design
OT  - subcutaneous injection depth
EDAT- 2020/02/29 06:00
MHDA- 2021/01/27 06:00
CRDT- 2020/02/29 06:00
PHST- 2019/10/13 00:00 [received]
PHST- 2020/02/11 00:00 [accepted]
PHST- 2020/02/29 06:00 [entrez]
PHST- 2020/02/29 06:00 [pubmed]
PHST- 2021/01/27 06:00 [medline]
AID - 10.1208/s12248-020-0433-8 [pii]
AID - 10.1208/s12248-020-0433-8 [doi]
PST - epublish
SO  - AAPS J. 2020 Feb 27;22(2):52. doi: 10.1208/s12248-020-0433-8.