| 000 | 01718 a2200469 4500 | ||
|---|---|---|---|
| 005 | 20250516144347.0 | ||
| 264 | 0 | _c20130930 | |
| 008 | 201309s 0 0 eng d | ||
| 022 | _a1532-6535 | ||
| 024 | 7 |
_a10.1038/clpt.2013.70 _2doi |
|
| 040 |
_aNLM _beng _cNLM |
||
| 100 | 1 | _aKhin, N A | |
| 245 | 0 | 0 |
_aRegulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective. _h[electronic resource] |
| 260 |
_bClinical pharmacology and therapeutics _cAug 2013 |
||
| 300 |
_a230-42 p. _bdigital |
||
| 500 | _aPublication Type: Journal Article | ||
| 650 | 0 | 4 |
_aAntipsychotic Agents _xtherapeutic use |
| 650 | 0 | 4 |
_aCardiovascular Agents _xtherapeutic use |
| 650 | 0 | 4 |
_aClinical Trials as Topic _xlegislation & jurisprudence |
| 650 | 0 | 4 |
_aDrug Approval _xorganization & administration |
| 650 | 0 | 4 | _aGuidelines as Topic |
| 650 | 0 | 4 | _aHumans |
| 650 | 0 | 4 | _aInternationality |
| 650 | 0 | 4 |
_aOrphan Drug Production _xstatistics & numerical data |
| 650 | 0 | 4 |
_aPharmacology, Clinical _xorganization & administration |
| 650 | 0 | 4 | _aResearch Design |
| 650 | 0 | 4 | _aUnited States |
| 650 | 0 | 4 |
_aUnited States Food and Drug Administration _xlegislation & jurisprudence |
| 700 | 1 | _aYang, P | |
| 700 | 1 | _aHung, H M J | |
| 700 | 1 | _aMaung-U, K | |
| 700 | 1 | _aChen, Y-F | |
| 700 | 1 | _aMeeker-O'Connell, A | |
| 700 | 1 | _aOkwesili, P | |
| 700 | 1 | _aYasuda, S U | |
| 700 | 1 | _aBall, L K | |
| 700 | 1 | _aHuang, S-M | |
| 700 | 1 | _aO'Neill, R T | |
| 700 | 1 | _aTemple, R | |
| 773 | 0 |
_tClinical pharmacology and therapeutics _gvol. 94 _gno. 2 _gp. 230-42 |
|
| 856 | 4 | 0 |
_uhttps://doi.org/10.1038/clpt.2013.70 _zAvailable from publisher's website |
| 999 |
_c22671530 _d22671530 |
||