搜索页_ Abbreviated New Drug Application (ANDA)

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Elsevier电子期刊(10)

在“Elsevier电子期刊”中，命中：10条，耗时：0.0889886 秒

在所有数据库中总计命中：17条

1.Demonstration of equivalence of a generic glatiramer acetate (Glatopa™)

关键词：ANDA ; Abbreviated New Drug Application ; APC ; antigen-presenting cell ; CNS ; central nervous system ; DEA ; diethylamine ; EAE ; experimental autoimmune encephalomyelitis ; ELISA ; enzyme-linked immunosorbent assay ; FDA ; Food and Drug Administration ; GA ; glatiramer acetate ; MHC ; major histocompatibility complex ; mAbs ; monoclonal antibodies ; MS ; multiple sclerosis ; MOG ; myelin oligodendrocyte glycoprotein ; NCAs ; N-carboxyanhydrides ; PLP ; proteolipid peptide

刊名：Journal of the Neurological Sciences

出版年：2015

2.In vitro-in vivo correlation for complex non-oral drug products: Where do we stand?

作者：Jie Shen ; Diane J. Burgess ; ^{d.burgess@uconn.edu" class="auth_mail" title="E-mail the corresponding author}

关键词：In vitro&ndash ; in vivo correlation (IVIVC) ; Non-oral ; Parenteral ; Prediction ; In vitro release testing ; Modeling

刊名：Journal of Controlled Release

出版年：2015

3.Forced degradation studies to assess the stability of drugs and products

作者：Saranjit Singh ; Mahendra Junwal ; Gajanan Modhe ; Harsita Tiwari ; Moolch ; Kurmi ; Neha Parashar ; Padmaja Sidduri

关键词：AAPH ; 2 ; 2&prime ; -Azobis(2-amidinopropane) dihydrochloride ; ACVA ; 4 ; 4&prime ; -Azobis(4-cyanopentanoicacid) ; AIBN ; Azobisisobutyronitrile ; ANDAs ; Abbreviated new drug applications ; API ; Active pharmaceutical ingredient ; ASEAN ; Association of Southeast Asian

刊名：TrAC Trends in Analytical Chemistry

出版年：2013

4.Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products

作者：Sven ; Stegemann^a ; ; ^{Sven.Stegemann@capsugel.com} ; Imre ; Klebovich^b ; Istvá ; n ; Antal^b ; Henning H. ; Blume^c ; Ká ; lmá ; n ; Magyar^d ; Gyö ; rgy ; Né ; meth^e ; Tamá ; s L. ; Paá ; l^f ; Willibald ; Stumptner^g ; Gyö ; rgy ; Thaler^e ; Armand ; Van de Putte^a ; Vinod P. ; Shah^h

关键词：Innovative drug products ; Generics and supergenerics ; Pharmaceutics and Biopharmaceutics ; Value of improved therapeutic entities ; Patient centric drug delivery ; Regulatory framework in FDA and EMA

刊名：European Journal of Pharmaceutical Sciences

出版年：2011

5.Evaluation of metered dose inhaler spray velocities using Phase Doppler Anemometry (PDA)

作者：Xiaofei Liu ; William H. Doub ; Changning Guo ; ^{changning.guo@fda.hhs.gov}

关键词：Metered dose inhaler ; MDI ; Droplet velocity ; Droplet size ; Phase Doppler Anemometry

刊名：International Journal of Pharmaceutics

出版年：2012

6.Pharmaceutical impurities: Regulatory perspective for Abbreviated New Drug Applications

关键词：Impurity ; Drug substance ; Drug product ; Abbreviated New Drug Applications (ANDAs)

刊名：Advanced Drug Delivery Reviews

出版年：2007

7.Regulatory considerations of pharmaceutical solid polymorphism in Abbreviated New Drug Applications (ANDAs)

作者：Raw ; Andre S. ; Furness ; M. Scott ; Gill ; Devinder S. ; Adams ; Richard C. ; Holcombe Jr ; Frank O. ; et. al.

关键词：Polymorphism ; Polymorph ; Abbreviated New Drug Application (ANDA) ; Drug substance ; Drug product ; Pharmaceutical solid

刊名：Advanced Drug Delivery Reviews

出版年：2004

8.Balancing US patent and FDA approval processes: strategically optimizing market exclusivity

作者：Fernandez ; Dennis S. ; Huie ; James T.

关键词：Drug Discovery ; United States Patent and Trademark Office (USPTO) ; Federal Drug Administration (FDA) ; biopharmaceuticals ; FDA clinical studies ; New Drug Application (NDA) ; market exclusivity ; generic market entry ; Abbreviated New Drug Application (ANDA)

刊名：Drug Discovery Today

出版年：2004

9.CLINICAL PHARMACOKINETIC REGISTRATION FILE FOR NDA AND ANDA PROCEDURES

作者：MARZO ; A.

刊名：Pharmacological Research

出版年：1997

10.Open questions in bioequivalence

作者：Antonio Marzo

关键词：bioequivalence ; intrasubject variability ; half-life ; endogenous substances ; stereogenic centres

刊名：Pharmacological Research

出版年：1995

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