Can give a talk as to how we do an ANDA through A to Z. Just use some kind
of generic drug as an example. Literature search work, similar product on
market, price, profits and market prospect; then drug substance (API)
analysis (source and purity); formulation work (excipient source and
selection); drug product master files (HPLC methodology development and
validation, physical and chemical constants, other instrumentation and wet
chemistry, dissolution, stability test, relative substances); pharmacology
and toxicology (animal test); manufacture report and QC; waiver of clinical
trial; specification and use of this drug (strength, purity, package et al)
;
For some kind of drug in which API can not be obtained in China, this
process is more complex. Drug substance synthesis have to be monitored and
assayed from starting materials, intermediates, impurities, by products and
final API product. The drug files could be double. Then going though all
other procedures like generic drug.
You know, in China, they seldom develop a totally new drug. But all those
experiences from here are enough for an analytical chemist to work in US.
They also conduct work in compliance with cGMPs (mainly for APIs), GLP,
safety and regulatory requirements.
Although I just participate in some of work , like formulation, animal test,
organic synthesis and manufacture, I was required to organize and conduct
every section, and responsible for final drug profile submission to SFDA and
provide sample and reference and method transfer into their instrument.
After approval, I still need to do quality assay and troubleshoot for
production. Whatever, they all can be talked as part of your work. Of
course, you should work very hard so you can meet timeline set by leader.
So our colleagues and I worked from 7:30 am to 11:30 pm almost every day (
just an additional convenient dinner is offered), and also frequently worked
on weekends and holidays. A large amount of experiments and files have to
be finished. And multiple projects have to be performed at the same time.
You can read some materials from FDA or SFDA, finding a general case
similar to your already finished one (so there is no worry about secret
leaking), and then describing how you did or will do analysis on this case.
I feel you may search some ppt at google about drug analysis, and hope
to incorporate your knowledge into them. For pharm analysis, there is only
one interesting thing---method development. That's only thing you may
develop your own idea on your work. Other works are routine and chore.
But you don't want to show you are hating that while hunting job. You
should force you love it, then the people you hope to service will love you.
Americans are always overconfident on talking their work or others' work
even if they did that not so well. Actually we should learn it from that,
and talk about our work with enough water and enthusiasm.
Btw, you should talk to your boss at first beginning, to show what you
finished, how diligent you are (do not talk others lazy) and you deserve
double pay. If you did not fight back, they just pretended they didn't
know this thing (looks like this is some kind of American courtesy). Of
course, now it's better time to move on.