Black WJ: Drug products of recombinant DNA technology. Am J Hosp Pharm46:1834-1844,1989
2.
Miller HI, Young FE: The drug approval process at the Food and Drug Administration—New biotechnology as a paradigm of a science-based activist approach. Arch Intern Med149:655-657, 1989
3.
Sethi ML: Recombinant DNA technology and therapeutic products. PharmTimes56:122-133, 1990
4.
Anon: Biotechnology medicines in development—90 biotech drugs and 14 vaccines in the pipeline. Washington, DC, Pharmaceutical Manufacturers Association, 1990
5.
Anon: Immunotherapeutics—A new direction in cancer treatment, in Cancer Insights, No. 2. Emeryville, CA, Cetus Corporation, 1989
6.
Garnick RL, Solli NJ, Papa PA: The role of quality control in biotechnology: An analytical perspective . Anal Chem60:2546-2557,1988
7.
Anicetti VR, Keyt BA, Hancock WS: Purity analysis of protein pharmaceuticals produced by recombinant DNA technology . Trends BioTech7:342-349, 1989
8.
Donahue RE, Wang EA, Kaufman RJ, et al: Effects of N-linked carbohydrate on the in vivo properties of human GM-CSF. Cold Spring Harbor Symp Quant Biol51:685-692, 1986
9.
Hotchkiss A. , Refino CJ, Leonard CK, et al: The influence of carbohydrate structure on the clearance of recombinant tissue-type plasminogen activator. Thromb Haemost60:255-261, 1988
10.
Garabedian HD, Gold HK, Leinbach RC, et al: Comparative properties of two clinical preparations of recombinant human tissue-type plasminogen activator in patients with acute myocardial infarction. J Am Coll Cardiol9:599-607, 1987
11.
Food and Drug Administration: Guidelines for submitting documentation for the stability of human drugs and biologics. February 1987
12.
Geigert J.: Overview of the stability and handling of recombinant protein drugs. J ParenterSci Technol43:220-224,1989
13.
Lee CY, Mauro VF, Alexander KS: Visual and spectrophotometric determination of compatibility of alteplase and streptokinase with other injectable drugs. Am J Hosp Pharm47:606-608, 1990
14.
Cossum PA: Pharmacologic basis for the safety assessment of recombinant human proteins . J Am Coll Toxicol8:1133-1138, 1989
15.
Hill DE: Regulating biotechnology licensed products. J Parenter Sci Tech43:139-141,1989
16.
Slater M.: Regulatory affairs issues in biotechnology. Drug Info J22:123-131, 1988
17.
Carter M.: Practical points to consider from the manufacturers' perspective in developing recombinant products. Regul Affairs1:111-118, 1989
Chang TM, Langer R., Sparks RE, et al: Drug delivery sytems in biotechnology. Artif Organs12:248-251,1988 20. Weiner AL: Developing lipid-based vehicles for peptide and protein drugs—Part 1: Selection and analysis issues. BioPharm27-32,1990
20.
Stein CA, Cohen JS: Oligodeoxynucleotides as inhibitors of gene expression: A review. Cancer Res48:2659-2668, 1988
21.
Walder J.: Antisense DNA and RNA: Progress and prospects. Genes Dev2:502-504, 1988
22.
Riordan JR, Rommens JM, Kerem B., et al: Identification of the cystic fibrosis gene: Cloning and characterization of complementary DNA. Science245:1066-1073, 1989
23.
Stewart CF, Fleming RA: Biotechnology products: New opportunities and responsibilities for the pharmacist . Am J Hosp Pharm46:S4-S8, 1989 (suppl)
24.
Montague MJ : The impact of biotechnology on the practice of pharmacy in the year 2000. Consult Pharm4:26-30, 1989 (suppl)
