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Drug Information Journal
Volumn 30, Issue 3, 1996, Pages 593-599
The interactive IND/NDA
Author keywords

Food and Drug Administration; Interactive IND NDA; Review and approval process; Sponsor
Indexed keywords

DRUG APPROVAL; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; PEER REVIEW; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW;
EID: 0029833505     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159603000301     Document Type: Review
Times cited : (1)
References (7)
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    • NDA Days-An update
    • Owens ML. NDA Days-An update. Reg Affairs. 1991;3:217-222.
    • (1991) Reg Affairs. , vol.3 , pp. 217-222
    • Owens, M.L.1
  • 3
    • 33847423484 scopus 로고
    • New drug approval -it's a whole new ball game
    • Harter J. New drug approval -it's a whole new ball game. RAPS News. March 1993.
    • (1993) RAPS News. March
    • Harter, J.1
  • 4
    • 33847486921 scopus 로고
    • Keep your NDAs "lean" to cut drug development time
    • Peck CC. Keep your NDAs "lean" to cut drug development time. Med Market Media. 1991; 34-42.
    • (1991) Med Market Media. , pp. 34-42
    • Peck, C.C.1
  • 5
    • 0026079187 scopus 로고
    • Pharmacodynamic modelling: Application to new drug development
    • Kroboth PO, Schmith VD, Smith RB. Pharmacodynamic modelling: Application to new drug development. Clin Pharmacokin. 1991;20:91-98.
    • (1991) Clin Pharmacokin. , vol.20 , pp. 91-98
    • Kroboth, P.O.1    Schmith, V.D.2    Smith, R.B.3
  • 6
    • 0027078803 scopus 로고
    • NDA Day: The approval of a neuromuscular blocking agent
    • Miller L, Abou-Donia M, Rudd D, et al. NDA Day: The approval of a neuromuscular blocking agent. J Clin Res Pharmacoep. 1992;6:271-284.
    • (1992) J Clin Res Pharmacoep. , vol.6 , pp. 271-284
    • Miller, L.1    Abou-Donia, M.2    Rudd, D.3
  • 7
    • 33847442808 scopus 로고
    • An 18-day approval becomes reality
    • Grudzinskas, C, Wright C. An 18-day approval becomes reality. Pharmaecut Exec. 1994; October:74-80.
    • (1994) Pharmaecut Exec. , pp. 74-80
    • Grudzinskas1    Wright C, C.2

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.