Maintaining the cold chain shipping environment for Phase I clinical trial distribution

Author:

Elliott M.A.,Halbert G.W.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference11 articles.

1. CRC/EORTC/NCI Joint Formulation Working Party: experiences in the formulation of investigational cytotoxic drugs;Beijnen;Br. J. Cancer,1995

2. A phase II trial of bryostatin-1 administered by weekly 24-hour infusion in recurrent epithelial ovarian carcinoma;Clamp;Br. J. Cancer,2003

3. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. OJ L 262, 14.10.2003, p. 22.

4. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. OJ L 121, 1.5.2001, p. 34.

5. Development of a lyophilized RH1 formulation: a novel DT diaphorase activated alkylating agent;Elliott;J. Pharm. Pharmacol.,2002

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