Transition from temporal to biological control in the clinical development of controlled drug delivery systems

Journal of Controlled Release

Volumn 39, Issue 2-3, 1996, Pages 389-397

  Sanders, Steven W ^a  

^a TheraTech Inc   (United States)

Author keywords

Amphotericin B; Controlled drug delivery; Drug development; Testosterone; Theophylline

Indexed keywords

AMPHOTERICIN B; AMPHOTERICIN B CHOLESTEROL SULFATE; AMPHOTERICIN B DEOXYCHOLATE; AMPHOTERICIN B LIPID COMPLEX; TESTOSTERONE; THEOPHYLLINE;

ADULT; BIOLOGICAL RHYTHM; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG ANALYSIS; DRUG DELIVERY SYSTEM; DRUG DESIGN; DRUG DEVELOPMENT; DRUG DISTRIBUTION; DRUG DOSAGE FORM; DRUG DOSE; DRUG FORMULATION; DRUG RELEASE; FEMALE; HORMONE RELEASE; HUMAN; HUMAN CELL; HUMAN TISSUE; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; ORAL DRUG ADMINISTRATION; PHARMACEUTICS; PRIORITY JOURNAL; RETICULOENDOTHELIAL SYSTEM; SUSTAINED RELEASE PREPARATION; TRANSDERMAL DRUG ADMINISTRATION;

EID: 0029949269     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/0168-3659(95)00168-9     Document Type: Conference Paper

References (12)

1. M.H. Smolensky, G.E. D'Alonzo, G. Kunkel and P.J. Barnes, Day-night patterns in bronchial patency and dyspnea: Basis for once daily and unequally divided twice-daily theophylline dosing schedules, Chronobiol. Int. 4 (1987) 303-317.
2. P. Dorow and V.W. Steinijans, Therapeutic advantages of unequal dosing of theophylline in patients with nocturnal asthma, Chronobiol. Int. 4 (1987) 349-357.
3. M.V. Middle, F.O. Müller, R. Schall, F.P.J. Le Roux and J.B. du Plessis, Double-blind randomized cross-over trials of nocturnal elixir theophylline supplementation of a twice-daily sustained-release theophylline tablet formulation in asthmatic patients, Chronobiol. Int. 10 (1993) 277-289.
4. L.J. Lesko, D. Brousseau, A.T. Canada et al., Temporal variations in trough serum theophylline concentrations at steady-state, J. Pharm. Sci. 69 (1980) 358-359.
5. E.W. Merritt and E.R. Cooper, Diffusion apparatus for skin penetration, J. Control. Release 1 (1984) 161-162.
6. N.A. Mazer, S.W. Sanders, C.D. Ebert and A.W. Meikle, Mimicking the circadian pattern of testosterone and metabolite levels with an enhanced transdermal delivery system, in: R. Gurney, H. Junginger and N. Peppas (Eds), Pulsatile Drug Delivery: Current Applications and Future Trends, Wissenschaftliche Verlagsgesellschaft, Stuttgart, 1993, pp. 73-97.
7. H. Gallis, R.H. Drew and W.W. Pichard, Amphotericin B: 30 years of clinical experience, Rev. Infect. Dis. 12 (1990) 308-329.
8. S. de Marie, R. Janknegt and A.J.M. Bakker-Woudenberg, Clinical use of liposomal and lipid-complexed amphotericin B, J. Antimicrobial Chemother. 33 (1994) 907-916.
9. R.M. Fielding, A.W. Singer, L.H. Wang, W. Babbar and L.S.S. Guo, Relationship of pharmacokinetics and drug distribution in tissue to increased safety of amphotericin B colloidal dispersion in dogs, Antimicrobial Agents Chemother. 36 (1992) 299-307.
10. L.H. Hanson and D.A. Stevens, Comparison of antifungal activity of amphotericin B deoxycholate suspension with that of amphotericin B cholestryl sulfate colloidal dispersion, Antimicrobial Agents Chemother. 36 (1992) 486-488.
11. M.C. Allende, J.W. Lee, P. Francis, K. Garrett, H. Dollenberg, J. Berenguer, C.A. Lyman, P.A. Pizzo and T.J. Walsh, Dose-dependent antifungal activity and nephrotoxicity of amphotericin B colloidal dispersion in experimental pulmonary aspergillosis, Antimicrobial Agents Chemother. 38 (1994) 518-522.
12. D.A. Stevens, Overview of amphotericin B colloidal dispersion (Amphocil), J. Infect. 8 (19941) 45-49.