Drug product formulation

Drug substance/drug product purity, potency, and other testing Drug substance/drug product stability testing Method development, validation, and transfer Drug product formulation development... 

In drug product formulation work, steps are taken to reduce or prevent the occurrence of drug substance deterioration due to hydrolysis, oxidation, and other processes. 

Eollowing finalization of drug substance synthetic routes and drug product formulation, the focus shifts to the development of robust and transferable methods for post-approval support at quality control units. It is important to remember during the final stage of method development that achievement of separation conditions is only one of the necessary parameters for successful method implementation. Extensive studies to measure robustness and quantitative method performance are conducted to assure that the method performs as intended in quality control laboratories. It should be emphasized that successful method development requires extensive cooperation between the development laboratory and the receiving quality control laboratories. 

For purposes of this part, such patents consist of drug substance (ingredient) patents, drug product (formulation and composition) patents, and method of use patents. 

Because microbiological test results from a water system are not usually obtained until after the dmg product is manufactured, results exceeding limits shall be reviewed with regard to the drug product formulated from such water. Consideration with regard to the further processing or release of such a product will depend upon the specific contaminant, the process, and the end use of the product. Such situations are usually evaluated on a case-by-case basis. 

Pinal UF/DP and Sterile Filtration concentration and buffer exchange for long-term product storage or preparation for drug product formulation... 

Biobatch The lot of drug product formulated for purposes of pharmacokinetic evaluation in a bioavailabUity/bioequivalency study. For modified release solid oral, this batch should be 10% or greater than the proposed commercial production batch or at least 100,000 units, whichever is greater. 

Kim S, Lotz B, Lindrud M, Girard K, Moore T, Nagarajan K, Alvarez M, Lee T, Nikfar F, Davidovich M, Srivastava S, Kiang S. 2005. Control of particle properties of a chug substance by crystallization engineering and the effect on drug product formulation. OPR D 9 894-901. 

Toxicological evaluation of identified and unidentified impurities from a container can help improve the safety index of drug products. The toxicological evaluation should take into consideration container closure system properties, drug product formulation, dosage form, route of administration, and dose regimen. A close correlation between chemical and toxicological information can provide better control on safety and compatibility of containers and closures. 

Biotechnology-Derived Drug Products Formulation Development, p. 281. 

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