Dmg development

Congress of New Dmg Development, Seoul, South Korea, August 18, 1991) The Pharmaceutical Society of Korea, Seoul, 1991, pp. 547—555. 

The U.S. Eood and Dmg Administration (EDA) approved 22 new dmgs and one biotech medicine during 1994. These new dmg entities had an adjusted average review time of 19.7 months, from filing of the New Dmg AppHcation (NDA) at the EDA to time of approval. This was down from the 25.6 months for the 26 new entities approval in 1993. In the total dmg development and approval process it takes approximately 12 years for an experimental... 

There is increasing pressure to develop homochiral dmgs (34). Growing demands are faced by the pharmaceutical industry in dmg development to consider chiral issues in the eady preclinical phases of dmg design and synthesis. 

Ref. 4 presents a useful survey of the process of dmg development from the regulatory perspective. 

A monograph (1) covers the pioneering period of sulfa dmg development and describes over 5000 sulfanilamide derivatives, their preparation, properties, trade names, and biological testing. This review is remarkably complete through 1944. Several thousand additional derivatives have been made since, but no comparable coverage is available. A definitive account of medical appHcations up to 1960 has been pubHshed (2), and a review of experimental antibacterial aspects has been made (3). Chapters on general aspects of sulfonamides and sulfones have appeared (4,5). A review of the clinical efficacy of trimethoprim—sulfamethoxazole has been pubHshed (6). 

In addition to being used for screening purposes for new dmg development, labeled dmgs and ligands are widely used by pharmaceutical companies for metabohc, bioavailabihty, and toxicological studies to support new dmg appHcations for FDA approval. 

MISRA R (1998) Modem dmg development from traditional medicinal plants using radiohgand receptor-hinding assays. Med Res Rev. 18 383-402. 

Ledley FD. Can pharmacogenomics make a difference in dmg development Nature Biotechnol 1999 17 731. 

Getz KA et al. Breaking the development speed barrier assessing successful practices of the fastest dmg developing companies. DIJ 2000 34 725-736. 

Roses A. Pharmacogenetics and future dmg development and delivery. Lancet 2000 355 1358-1361. 

Dmg Development Metabolite identification Identification and quantitation No Medium to high... 

The parallel screening of drug candidates for their pharmacological activity and for their physicochemical and biopharmaceutical properties has become a major challenge in dmg development and is performed at very early stages... 

Toutain, P.L., Pharmacokinetic/pharmacodynamic integration in dmg development and dosage-regimen optimization for veterinary medicine, AAPS PharmSci., 4, 2002. 

Parkinson s disease A degenerative disease of the nervous system characterized hy tremor and impaired muscular coordination, patient-directed designer drug A dmg developed to meet the medical needs of very specific fypes of individuals, pharmacopoeia A catalog of drugs, chemicals, and medicinal preparations. 

Veber, D. E, Drake, F. H. and Gowen, M. (1997). The new partnership of genomics and chemistry for accelerated dmg development. Curr. Opin. Chem. Biol. 1, 151-156. 

Direct isolation ( one-pot ) processes should be considered for materials prepared for Phase 2 and later development. Examples of this were shown in Schemes 2.3 and 2.4 for the tosylate salt 13 and the product 15 from the Dimroth rearrangement. Considerable processing time may be saved, resulting in lower COG from reduced labor costs. The attendant savings on solvent costs and waste disposal can also reduce COG. Some research time may be necessary to develop these processes, in particular fine-tuning the processes to purge impurities. In early phases of dmg development the fastest scale-up may be through conventional extractive work-up, concentration, and crystallization. 

Lesko, L.J., M. Rowland, C.C. Peck, and T.F. Blaschke. 2000. Optimizing the science of dmg development Opportunities for better candidate selection and accelerated evaluation in humans./. Clin. Pharmacol. 40 803-814. 

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