Challenges with advanced therapy medicinal products and how to meet them

Nature Reviews Drug Discovery

Volumn 9, Issue 3, 2010, Pages 195-201

  Schneider, Christian K ^a,b   Celis, Patrick ^c   Salmikangas, Paula ^d   Figuerola Santos, María Angeles ^d   D'Apote, Lucia ^d   Oliver Diaz, Olga ^d   Büttel, Isabel ^d   Mačiulaitis, Romaldas ^d   Robert, Jean Louis ^d   Silva Lima, Beatriz ^d   Ruiz, Sol ^d   Jilma, Bernd ^d   Flamion, Bruno ^d   Racheva Todorova, Lyubina ^d   Paphitou, Anna ^d   Haunerova, Ivana ^d   Clausen, Mette ^d   Maimets, Toivo ^d   Trouvin, Jean Hugues ^d   Flory, Egbert ^d   Tsiftsoglou, Asterios ^d   Sarkadi, Balázs ^d   Gudmundsson, Kolbeinn ^d   O'Donovan, Maura ^d   Migliaccio, Giovanni ^d   Ancans, Janis ^d   Samuel, Anthony ^d   Ovelgönne, Johannes H ^d   Hystad, Marit ^d   Mariusz Fal, Andrzej ^d   Stela Moraru, Anca ^d   Turčáni, Peter ^d   Zorec, Robert ^d   Åkerblom, Lennart ^d   Narayanan, Gopalan ^d   Kent, Alastair ^e   Bignami, Fabrizia ^f   George Dickson, J ^g   Niederwieser, Dietger ^h   more..

^a PAUL EHRLICH INSTITUT   (Germany)

^b INSTITUTE OF INFECTION IMMUNOLOGY   (Germany)

^c EUROPEAN MEDICINES AGENCY   (United Kingdom)

^d European Genetic Alliances' Network ^*

^e European Genetic Alliances' Network   (Netherlands)

^f European Organisation for rare Diseases   (Netherlands)

^g European society of Gene and Cell Therapy   (Netherlands)

^h European Group for Blood and Marrow Transplantations   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

VIRUS VECTOR;

ADVANCED THERAPY MEDICINAL PRODUCT; AUTHORITY; BIOTECHNOLOGICAL PRODUCTION; BIOTECHNOLOGY; CANCER GENE THERAPY; CLASSIFICATION; CLINICAL STUDY; EUROPEAN UNION; EXPERIMENTAL ANIMAL; EXPERIMENTAL MODEL; GENE THERAPY; GENE TRANSFER; GENE VECTOR; HEALTH CARE POLICY; LAW; MEDICAL ETHICS; NOTE; PRIORITY JOURNAL; QUALITY CONTROL; SAFETY; SOMATIC CELL THERAPY; STABLE EXPRESSION; STANDARD; STEM CELL; TISSUE ENGINEERING; TOXICOLOGY; TRANSGENE;

EID: 77649194372     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd3052     Document Type: Note

References (29)

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