id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-017208-7oew461e	Aurigemma, Rosemarie	Regulatory Aspects in the Development of Gene Therapies	2005		.txt	text/plain	18290	816	37	Table 1 Beyond a Good Idea: What the Successful Investigator Has Already Done With a Project Leading to Commercial Development Defined candidate biologic (or molecule) Made comparisons with similar products Characteristics of product are consistent with pharmaceutical requirements Production scale is adequate Product characterization is adequate Laboratory reference standard exists In vitro potency assay has been developed Stability studies develop confidence product is a "drug" Reproducible model systems have confirmed in vivo activity with clinical product Early animal work includes some toxicology Scale-up requirements practical for initial clinical trials In general, reflects experience and scientific maturity of investigator In addition to the US agencies that develop the regulations that govern drug development and licensing, the International Conference on Harmonization (ICH) was formed in April 1990 involving the United States, the European Union, and Japan to address the issue of globalizing such regulations.	./cache/cord-017208-7oew461e.txt	./txt/cord-017208-7oew461e.txt