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Items: 1 to 20 of 135

1.
2.

Challenges and opportunities in bringing new medications to market for pediatric patients.

Upadhyaya HP, Gault L, Allen AJ.

J Am Acad Child Adolesc Psychiatry. 2009 Nov;48(11):1056-9. doi: 10.1097/CHI.0b013e3181baec67. No abstract available.

PMID:
19855220
3.
4.

Drug development history, "overview," and what are GCPs?

Heilman RD.

Qual Assur. 1995 Mar;4(1):75-9.

PMID:
8520867
6.

Industry perspectives on ICH guidelines.

Rockhold FW.

Stat Med. 2002 Oct 15;21(19):2949-57.

PMID:
12325111
7.

[Development of antituberculous drugs: current status and future prospects].

Tomioka H, Namba K.

Kekkaku. 2006 Dec;81(12):753-74. Review. Japanese.

PMID:
17240921
8.

Assuring the quality, safety, and efficacy of DNA vaccines.

Robertson JS, Griffiths E.

Methods Mol Med. 2006;127:363-74. Review.

PMID:
16988466
9.

Drug development process for a product with a primary pediatric indication.

Allen AJ, Michelson D.

J Clin Psychiatry. 2002;63 Suppl 12:44-9.

10.

Drug discovery and development in the pharmaceutical industry.

Schacter LP, Anderson C, Canetta RM, Kelley S, Nicaise C, Onetto N, Rozencweig M, Smaldone L, Winograd B.

Semin Oncol. 1992 Dec;19(6):613-21. Review.

PMID:
1462163
11.
12.

INGN 201: Ad-p53, Ad5CMV-p53, adenoviral p53, p53 gene therapy--introgen, RPR/INGN 201.

[No authors listed]

Drugs R D. 2007;8(3):176-87. Review.

PMID:
17472413
13.

Promoting, improving and accelerating the drug development and approval processes.

Graul AI.

Drug News Perspect. 2007 Jan-Feb;20(1):45-55.

PMID:
17332899
14.

Lessons learned from independent central review.

Ford R, Schwartz L, Dancey J, Dodd LE, Eisenhauer EA, Gwyther S, Rubinstein L, Sargent D, Shankar L, Therasse P, Verweij J.

Eur J Cancer. 2009 Jan;45(2):268-74. doi: 10.1016/j.ejca.2008.10.031.

PMID:
19101138
15.

Process and product development in the manufacturing of molecular therapeutics.

Atkinson EM, Christensen JR.

Curr Opin Mol Ther. 1999 Aug;1(4):422-9. Review.

PMID:
11713755
16.
17.

Chiral drugs: the FDA perspective on manufacturing and control.

De Camp WH.

J Pharm Biomed Anal. 1993 Nov-Dec;11(11-12):1167-72.

PMID:
8123731
18.

Current status and future trends in vaccine regulation--USA.

Falk LA, Ball LK.

Vaccine. 2001 Feb 8;19(13-14):1567-72.

PMID:
11166876
19.

Two-stage drug approval would reduce the risks.

Frantz JA.

Nature. 2005 May 12;435(7039):143. No abstract available.

PMID:
15889063
20.

Oncology drug development: United States Food and Drug Administration perspective.

Hirschfeld S, Pazdur R.

Crit Rev Oncol Hematol. 2002 May;42(2):137-43. Review.

PMID:
12007971

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