Pharmaceutical evaluation

In a more traditional pharmaceutical setting, this characterization would be done during preformulation studies. With the availability of automation and the ability to conduct most of these experiments with small quantities of material, more preformulation activities are being shifted earlier into drug discovery. Recently, Balbach and Korn37 reported a "100 mg approach" to pharmaceutical evaluation of early development compounds. Additional absorption, metabolism, distribution, elimination, and toxicity38 screens may also be conducted at this stage. 

Information about the overseas status of the product was also now sought as part of an application. The list of countries mentioned in this context in the AGRDl included members of the Pharmaceutical Evaluation Report (PER) Scheme, other EC countries and the United States. Expert reports also began to be utilised in the evaluation of applications. 

On receipt of a major application for listing, the PBAC secretariat forwards the application to the Pharmaceutical Evaluation Section (PES). The PES evaluates these applications together with three external groups from academic institutions contracted for this work. The PES provides an evaluation report to the Economic Subcommittee (ESC) of the PBAC. The ESC reviews and interprets the economic analyses and advises the PBAC on these analyses. The PBAC also receives advice from the Drug Utilisation Subcommittee (DUSC). 

Matsuda, Y., Akazawa, R.,Teraoka, R., and Totsuka, M. (1994), Pharmaceutical evaluation of carbamazepine modifications Comparative study of photostability of carbamazepine polymorphs by using fourier-transformed reflection-absorption infrared spectrocopy and colorimetric measurement, / Pharm. Pharmacol., 46,162-167. 

Balbach, S. and C. Korn (2004). Pharmaceutical evaluation of early development candidates the 100 mg-approach.rht. J. Pharm., 275 1-12. 

Associate Professor, Division of Pharmaceutical Evaluation and Policy, University of Arkansas for Medical Sciences College of Pharmacy, Little Rock, Arkansas... 

There are several approaches that can be taken to supply material for pharmaceutical evaluation. Two of these, invertebrate cell culture and fermentation of associated microorganisms, begin with determining the biogenetic origin of the compound. There are numerous reports of metabolite localization, primarily in sponges, in which production of a bioactive metabolite has been inferred or demonstrated to be localized either in a host invertebrate cell or in microbial associates which include cyanobacteria and heterotrophic bacteria and fungi.72-73... 

Shyu, W. C., Mayol, R. F., Pfeffer, M., Pittman, K. A., and Barbhiya, R. H. (1993), Bio-pharmaceutical evaluation of transnasal, sublingual and buccal disk dosage forms of butorphanol, Biopharm. Drug Dispos., 14, 371-379. 

Pharmaceutical Evaluation of Vaginal Drug Delivery Systems... 

PHARMACEUTICAL EVALUATION OF VAGINAL DRUG DELIVERY SYSTEMS... 

Ribaita, J. M., Arttis, J. J., Salvador, 1.., Roma, E., Vilageliu, J., Freixes, J., and Bru-seghini, L., Synthesis and pharmaceutical evaluation of N-morpholinomethylurca derivatives with platelet antiaggregant activity, Arzneim, Forsch., 31, 1782, 1981. 

Yamamoto, M. Aritomi, H. Irie, T. Hirayama, F. Uekama, K. Pharmaceutical evaluation of branched P-cyclodextrins as parenteral drug carriers. Minutes 5th International Symposium on Cyelodextrins. Duchene, D., Ed. Editions de Sante Paris, 1990 541-544. 

Gizurarson S, Aggerback H, Gudmundsson M, Heron I. Intranasal vaccination pharmaceutical evaluation of the vaccine delivery system and immunokinetic characteristics of the immune response. Pharm Dev Technol 1998 3 385—394. 

CTs authorized by the NIP (including human phase IV ones) may be inspected by the NIP GCP inspectors. Between 1994 and 1997, the former EU GCP was applied while in 1999 the International Conference of Harmonization (ICH) GCP is used. All the deficiencies found are communicated, both verbally and later on in writing, to the investigator. In the case of major deficiencies, their improvement is required. In the case of critical deficiencies, the applicant/sponsor may cdso be informed and the trial would not be accepted for registration purposes in Hungary. Moreover, within the framework of the Pharmaceutical Evaluation Report (PER) Scheme, foreign PER authorities may be informed about the noncompliance found. 

For foreign drugs, the sample pharmaceutical evaluation is performed only if the SPEC requires efficacy or bioequivalence studies. In some cases the Pharmacological Committee may go for a random evaluation of drug samples. 

Pharmaceutical evaluation document and Product pre-registration/ evaluation report (MCC Circular 2/97)... 

Pharmaceutical evaluation document— This information is required by the quality assessors it is often however not appropriate for biologiccil applications, in which case it should be adapted appropriately. 

Balbach S and Korn C. Pharmaceutical Evaluation of Early Developmental Candidates The 100 mg Approach. IntJ Pharm 2004 275 1-12. 

Hirayama, F. Development and pharmaceutical evaluation of hydro-phobic derivatives as modified-release dmg carrier. Yakugaku. Zasshi 1993,113, 425-437. 

Uekama, K., Yamamoto, M., Me, T, Hirayama, F Pharmaceutical evaluation of maltosyl-(3-cyclodextrin as a drug earner in parenteral formulation. In Minutes of the 6th International Symposium on Cyclodextrins (Hedges, A. R., Ed.). Editions de Sante Paris, 1992, pp. 491-496. 

It remains to be seen what effect will be demonstrated by the brassinosteroids on the mammalian system, if any. If one accepts the thesis that the animal steroids had their genesis in a common phytosterol ancestor and that certain mechanisms evolved in the animal system for steroid production, the question then arises as to what responses are elicited in the mammalian system when it is challenged with select brassinosteroids. Another way of asking the question is, do the brassinosteroids have any medicinal value Until now, limited quantities have precluded such examinations, but because synthesis is becoming more efficient the day cannot be far off for pharmaceutical evaluations if, in fact, they have not been tested already. 

Andrew Mitchell Pharmaceutical Evaluation Department of Health Housing and Community Services Canberra, Australia... 

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