Considerations in developing a target product profile for parenteral pharmaceutical products

AAPS PharmSciTech

Volumn 11, Issue 3, 2010, Pages 1476-1481

  Lambert, William J ^a  

^a Pacira Pharmaceuticals Inc   (United States)

Author keywords

freeze dried; injectable; lyophile; quality by design; sterile product; target product profile

Indexed keywords

EXCIPIENT; PARENTERAL SOLUTION;

DRUG DELIVERY SYSTEM; DRUG DESIGN; DRUG FORMULATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG PACKAGING; DRUG STERILITY; DRUG STORAGE; DRUG UTILIZATION; PH; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; SHELF LIFE; SUSTAINED RELEASE FORMULATION; TARGET PRODUCT PROFILE; TREATMENT DURATION;

DRUG COMPOUNDING; DRUG DELIVERY SYSTEMS; INFUSIONS, PARENTERAL; TECHNOLOGY, PHARMACEUTICAL;

EID: 78649905370     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-010-9521-x     Document Type: Review

References (17)

1. Six Sigma. Wikipedia Web site. http://en.wikipedia.org/wiki/Six-Sigma.
2. T Grom 2010 Molecule to market: the drug-development timeline PharmaVoice 10 3 10 5
3. FDA. Draft guidance for industry and review staff, target product profile-a strategic development process tool. FDA, March 2007.
4. S Garg, et al. 2003 Development pharmaceutics of microbocode formulations. Part II: formulation, evaluation, and challenges AIDS Patient Care STDs 17 8 377 99 10.1089/108729103322277402 13678540 (Pubitemid 37034254)
5. Gibson M. Early drug development: product design. In: Gibson M, editor. Pharmaceutical preformulation and formulation. Boca Raton: CRC; 2004. p. 157-73.
6. MF Powell T Nguyen L Baloian 1998 Compendium of excipients for parenteral formulations PDA J Pharm Sci Technol 52 5 238 311 1:CAS:528:DyaK1MXmvFKh 9846074
7. RG Strickley 1999 Parenteral formulations of small molecule therapeutics marketed in the United States (1999)-Part I PDA J Pharm Sci Technol 53 6 324 49 1:CAS:528:DC%2BD3cXhsFKnsb8%3D 10754732
8. RG Strickley 1999 Parenteral formulations of small molecule therapeutics marketed in the United States (1999)-Part II PDA J Pharm Sci Technol 54 1 69 96
9. RG Strickley 1999 Parenteral formulations of small molecule therapeutics marketed in the United States (1999)-Part III PDA J Pharm Sci Technol 54 2 152 69
10. Y-CJ Wang RR Kowal 1980 Review of excipient and pH's for parenteral products used in the United States J Paraent Drug Assn 34 6 452 62 1:CAS:528:DyaL3MXht1OitLk%3D
11. DB Evans HL Guyatt 1997 Human behavior, cost-effectiveness analysis and research and development priorities: the case of a schistomiasis vaccine Trop Med Inter Health 2 11 A47 54 1:STN:280:DyaK1c%2FltlSisg%3D%3D
12. FDA. Guidance for industry, Q8(R2) pharmaceutical development. FDA, Nov 2009.
13. RA Lionberger, et al. 2008 Quality by design: concepts for ANDAs AAPS J 10 2 268 76 1:CAS:528:DC%2BD1cXhtlOgsbvP 10.1208/s12248-008-9026-7 18465252
14. LK Jim 1993 Physical and chemical compatibility of intravenous ciprofloxacin with other drugs Ann Pharmacother 27 6 704 7 1:CAS:528: DyaK3sXlsVKntL8%3D 8329786
15. MP McRae JC King 1976 Compatibility of antineoplastic, antibiotic and corticosteroid drugs in intravenous admixtures Amer J Hosp Pharm 33 10 1010 3 1:CAS:528:DyaE28XlvFyis74%3D
16. JF Dasta KN Hale GL Stauffer MM Tschampel 1988 Comparison of visual and turbidimetric methods for determining short-term compatibility of intravenous critical-care drugs Amer J Hosp Pharm 45 11 2361 6 1:CAS:528: DyaL1MXksVyntQ%3D%3D
17. PW Tebbey C Rink 2009 Target product profile: a renaissance for its definition and use J Med Mark 9 4 301 7 10.1057/jmm.2009.34