Info

Mutagenic potential (3 basic tests)

25,000-69,000

Carcinogenic potential (mice or rats)

1,124,000-2,287,000

Effect on reproductive performance

313,000-458,000

Complete Toxicology Budget

2,590,000-6,000,000

PLUS 1. Pharmacology (activity & efficacy, >>doses)

500,000-1,000,000

2. Pharmacokinetics (ADME) 3. Pharmacogenetics??

??

Fig. 4.30. Requirements & Costs for IND Studies (Adapted with permission from Nature Publishing Group, London, England. From Table in Preziosi P. Science, pharmacoeconomics and ethics in drug R&D: a sustainable future scenario. Nature Reviews Drug Discovery 2004;3(5):521-6. Table 2)

Fig. 4.30. Requirements & Costs for IND Studies (Adapted with permission from Nature Publishing Group, London, England. From Table in Preziosi P. Science, pharmacoeconomics and ethics in drug R&D: a sustainable future scenario. Nature Reviews Drug Discovery 2004;3(5):521-6. Table 2)

r Multiple assays are needed to ensure product consistency and potency r Common consistency assays include: O Appearance, concentration, pH, ionic strength, sterility, endotoxin, purity r Potency assays focus on specific properties of the product:

O Antibodies - Binding, ADCC, CMC, functional inhibition, etc O Enzymes - Catalytic activity

O Recombinant proteins - Functional activity or inhibition O Drugs - Functional activity or inhibition r Current trends include greater emphasis on biological or cell-based assays versus simple binding assays r All assays must be well controlled and reproducible: C Matrix effects - Blood, urine, sputum, mice vs. humans, etc. C Assay validation is not usually required until later in review process

Fig. 4.31. Analytical Assays

Source: Image from Amersham Biosciences (http://www.bloprocess.amershambiosscience.com)

the figure(4.30). Pharmacology work is listed here, as well the pharmacokinetic work (ADME).

As a product transitions from the research phase into process development and manufacturing, the requirements for standardized and reproducible assays increase (Fig. 4.31). Not surprisingly, many of the assays developed for the discovery work

(purity, potency, concentration, function, etc.) are often further refined and characterized during the technical development phase, so as to ensure their reliability. This slide lists seven common characteristics used to judge consistency of a product. Certain types of products will have specific properties that will require special assays (e.g., antibodies need assays for binding, antibody dependent cell cytotoxicity [ADCC]). Assays basically need to be doable by anyone trained in the field, involve a well-controlled process, and be reproducible. Ultimately, as a product works its way through clinical trials toward a marketing application, the necessary assays are "validated" to further ensure their uniformity and reproducibility.

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