Talk:Drug development

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need this for my homework[edit]

I need this for my homework but i can't understand the language being used. Please help me!!

Can you please clarify which part is not clear to you? This will allow to give a specific answer and an update of the article. JKW 15:46, 23 October 2006 (UTC)

Researchers Develop Simple Method to Create Natural Drug Products[edit]

We've been preparing for some time now a 'biological toolbox,'" said Moore. "In this new process the enzymes become the tools to do the synthesis." [1] Brian Pearson 02:38, 5 September 2007 (UTC)

What about phase I, phase II, etc?[edit]

Can I prevail on anyone to write sections about the drug development phases in clinical research? Is this found elsewhere on WP?--Dr.michael.benjamin 07:03, 22 October 2007 (UTC)

See clinical trial.~Stav~ (talk) 22:16, 23 February 2008 (UTC)

Lead optimization - not mentioned[edit]

Lead optimization is redirected to this article but the term is not even mentioned. Should lead optimization really be redirected here? pgr94 (talk) 11:14, 1 October 2008 (UTC)

Cost[edit]

The cost section is outdated. Does anyone have any objections to it being revised? Additionally does anyone know where more data can be obtained for post-2006? StarsTrainsAndRandomThings (talk) 15:10, 28 April 2009 (UTC)

I got something in German from the Buko. They state that the development would cost somewhere between 125 and 250mio$. And they make clear that it should be really 400mio $ instead of the 800mio $ including the opportunity costs (because you're developing something which will be sold as well). Oh, and that the Scientists calculating the former costs are mainly paid from the pharma industry. Ah, here Collier R., CMAJ. 2009 Feb 3;180(3):279-80., Drug development cost estimates hard to swallow., PMID: 19188620 we are. But he does also not give any new number. Light and Warburton, 2005, Extraordinary claims require extraordinary evidence, Journal of Health Economics Volume 24, Issue 5, September 2005, Pages 1030-1033 states 6 main critique points to the original study. But the original author is then trying to argue against that. While Adams CP and Brantner VV., Health Aff (Millwood). 2006 Mar-Apr;25(2):420-8. Estimating the cost of new drug development: is it really 802 million dollars? PMID: 16522582 estimates costs to vary from around 500 million dollars to more than 2,000 million dollars. Can someone maybe read through a bit of that and pack it into a nice and objective paragraph now? With so much subjective numbers I unfortunately lost my will and time to write something objective. Thanks ;-) Peterthewall (talk) 10:50, 19 January 2010 (UTC)

IND as FDA gateway to clinical trials[edit]

Article should mention the FDA Investigational New Drug (IND) as being required to start clinical trials. Rod57 (talk) 00:07, 23 November 2010 (UTC)

Not enough on clinical phase of drug development[edit]

Suspect original text (uncited) was very old - It doesn't seem to reflect current usage and practice and seems to need a rewrite or restructure. - Rod57 (talk) 09:57, 13 May 2011 (UTC)

US-centric[edit]

The content regarding the regulatory process only mentions the US regulations. the sidebar mentions the US specifically. I know that the FDA is something of a trendsetter in development and regulation, but that doesnt mean that only mentioning the US regulatory process (and estimates, e.g. diMasi) with a cursory mention of european initiatives at the end, is sufficiently globalized. -- UseTheCommandLine (talk) 19:41, 5 February 2013 (UTC)

FWIW, I intend on working on this article to expand its scope, including globalizing it a little. I just was hoping to attract other eyes to it in the meantime. there is a lot going on right now, especially at e.g. the international level, in an attempt to promote development of drugs that better serve public health needs. My hope was to put some of that information here over time.
Normally I hate when people just un-revert my reverts, but I do think it's pretty clear that the globalization tag applies. I notice that one of your peeves as an editor is people adding tags without fixing things, and I assure you, my intent is not to just tag bomb. You can see from my edit history that i am a fairly active editor on this topic (though today many of my edits have been procedural, e.g. AfDs, thats pretty rare for me).
I am going to replace the globalize tag, in hopes that this explanation is sufficient explanation of my rationale. If not, please feel free to re-revert and we can discuss it at greater length. -- UseTheCommandLine (talk) 20:01, 5 February 2013 (UTC)
Thanks this was perfect! I find things go quicker and with less wheel-spinning when people make their goals and points of unhappiness specific. I will be happy to help now that you have explained - these goals and points make sense. Jytdog (talk) 21:04, 5 February 2013 (UTC)
I completely agree about the US-centric issue, and particularly the inappropriate placement of the {{Regulation of therapeutic goods in the United States}} navbox sidebar. It shouldn't be placed at the top of a general section on drug development. If anything, a subsection on region-specific regulatory requirements should be added and expanded; the navbox sidebar would then be appropriate if added under the section that covers the USFDA's requirements. Seppi333 (Insert ) 16:52, 4 September 2015 (UTC)

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