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Book
Guidance for industry : ANDAs, impurities in drug products.
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Year: 2005 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Book
Guidance for industry : ANDAs, impurities in drug products.
Authors: ---
Year: 2005 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Periodical
Center for Drug Evaluation and Research update.
Author:
ISSN: 21502390 Year: 2007 Publisher: [Silver Spring, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Keywords

Drugs --- Pharmaceutical policy --- Drug approval --- Drug approval. --- Pharmaceutical policy. --- Drug Approval --- Drug Industry --- Testing --- Testing. --- Center for Drug Evaluation and Research (U.S.) --- United States. --- United States --- Industries, Pharmaceutic --- Industry, Drug --- Industry, Pharmaceutic --- Industry, Pharmaceutical --- Pharmaceutical Industry --- Drug Industries --- Industries, Drug --- Industries, Pharmaceutical --- Pharmaceutic Industries --- Pharmaceutic Industry --- Pharmaceutical Industries --- Food and Drug Administration Drug Approval --- Food and Drug Administration Drug Approval Process --- New Drug Approval Process --- Drug Approval Process --- New Drug Approval --- Approval Process, Drug --- Approval Processes, Drug --- Approval, Drug --- Approval, New Drug --- Approvals, Drug --- Approvals, New Drug --- Drug Approval Processes --- Drug Approval, New --- Drug Approvals --- Drug Approvals, New --- New Drug Approvals --- Process, Drug Approval --- Processes, Drug Approval --- Clinical Trials as Topic --- Off-Label Use --- Drug policy --- Drugs and state --- Pharmacy and state --- Pharmacy --- State and drugs --- State and pharmacy --- Medical policy --- Clinical drug trials --- Clinical trials of drugs --- Drug bioscreening --- Drug trials --- Clinical pharmacology --- Drug development --- Approval of drugs --- Approval of new drugs --- Drug approval process --- New drug approval --- Medicaments --- Medications --- Medicine (Drugs) --- Medicines (Drugs) --- Pharmaceuticals --- Prescription drugs --- Bioactive compounds --- Medical supplies --- Pharmacopoeias --- Chemotherapy --- Materia medica --- Pharmacology --- Government policy --- Clinical trials --- Effectiveness --- Evaluation --- C.D.E.R. --- CDER --- Center for Drugs and Biologics (U.S.) --- ABŞ --- ABSh --- Ameerika Ühendriigid --- America (Republic) --- Amerika Birlăshmish Shtatlary --- Amerika Birlăşmi Ştatları --- Amerika Birlăşmiş Ştatları --- Amerika ka Kelenyalen Jamanaw --- Amerika Qūrama Shtattary --- Amerika Qŭshma Shtatlari --- Amerika Qushma Shtattary --- Amerika (Republic) --- Amerikai Egyesült Államok --- Amerikanʹ Veĭtʹsėndi͡avks Shtattnė --- Amerikări Pĕrleshu̇llĕ Shtatsem --- Amerikas Forenede Stater --- Amerikayi Miatsʻyal Nahangner --- Ameriketako Estatu Batuak --- Amirika Carékat --- AQSh --- Ar. ha-B. --- Arhab --- Artsot ha-Berit --- Artzois Ha'bris --- Bí-kok --- Ē.P.A. --- É.-U. --- EE.UU. --- Egyesült Államok --- ĒPA --- Estados Unidos --- Estados Unidos da América do Norte --- Estados Unidos de América --- Estaos Xuníos --- Estaos Xuníos d'América --- Estatos Unitos --- Estatos Unitos d'America --- Estats Units d'Amèrica --- Ètats-Unis d'Amèrica --- États-Unis d'Amérique --- ÉU --- Fareyniḳṭe Shṭaṭn --- Feriene Steaten --- Feriene Steaten fan Amearika --- Forente stater --- FS --- Hēnomenai Politeiai Amerikēs --- Hēnōmenes Politeies tēs Amerikēs --- Hiwsisayin Amerikayi Miatsʻeal Tērutʻiwnkʻ --- Istadus Unidus --- Jungtinės Amerikos valstybės --- Mei guo --- Mei-kuo --- Meiguo --- Mî-koet --- Miatsʻyal Nahangner --- Miguk --- Na Stàitean Aonaichte --- NSA --- S.U.A. --- SAD --- Saharat ʻAmērikā --- SASht --- Severo-Amerikanskie Shtaty --- Severo-Amerikanskie Soedinennye Shtaty --- Si͡evero-Amerikanskīe Soedinennye Shtaty --- Sjedinjene Američke Države --- Soedinennye Shtaty Ameriki --- Soedinennye Shtaty Severnoĭ Ameriki --- Soedinennye Shtaty Si͡evernoĭ Ameriki --- Spojené obce severoamerické --- Spojené staty americké --- SShA --- Stadoù-Unanet Amerika --- Stáit Aontaithe Mheiriceá --- Stany Zjednoczone --- Stati Uniti --- Stati Uniti d'America --- Stâts Unîts --- Stâts Unîts di Americhe --- Steatyn Unnaneysit --- Steatyn Unnaneysit America --- SUA --- Sŭedineni amerikanski shtati --- Sŭedinenite shtati --- Tetã peteĩ reko Amérikagua --- U.S. --- U.S.A. --- United States of America --- Unol Daleithiau --- Unol Daleithiau America --- Unuiĝintaj Ŝtatoj de Ameriko --- US --- USA --- Usono --- Vaeinigte Staatn --- Vaeinigte Staatn vo Amerika --- Vereinigte Staaten --- Vereinigte Staaten von Amerika --- Verenigde State van Amerika --- Verenigde Staten --- VS --- VSA --- Wááshindoon Bikéyah Ałhidadiidzooígíí --- Wilāyāt al-Muttaḥidah --- Wilāyāt al-Muttaḥidah al-Amirīkīyah --- Wilāyāt al-Muttaḥidah al-Amrīkīyah --- Yhdysvallat --- Yunaeted Stet --- Yunaeted Stet blong Amerika --- ZDA --- Združene države Amerike --- Zʹi͡ednani Derz͡havy Ameryky --- Zjadnośone staty Ameriki --- Zluchanyi͡a Shtaty Ameryki --- Zlucheni Derz͡havy --- ZSA


Book
Guidance for industry : M4Q, the CTD, quality.
Author:
Year: 2001 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Book
Guidance for industry : investigating out-of-specification test results (OOS) for pharmaceutical production.
Author:
Year: 2006 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Keywords

Drug testing


Book
Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions.
Author:
Year: 2008 Publisher: [College Park, Md.?] : [Center for Drug Evaluation and Research],

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Book
Drug registration and listing instructions
Author:
Year: 1998 Publisher: [Rockville, Md.] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, Information Management Team,

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Keywords

Drugs --- Classification


Book
Guidance for industry : acute bacterial otitis media, developing drugs for treatment.
Author:
Year: 2008 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Book
Guidance for industry : incorporation of physical-chemical identifiers into solid oral dosage form drug products for anticounterfeiting.
Author:
Year: 2009 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Book
Studies in support of special populations, geriatrics
Author:
Year: 1994 Publisher: [Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Center for Drug Evaluation],

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Keywords

Drugs --- Geriatrics --- Testing.

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