1 research outputs found
Biosimilar Law and Regulation: An Essential Guide
- Author
- . . . Reporting
- . . Legalbasis
- . . Legalbasis
- . . Mainguidelinetext
- . . Post-Market Requirements
- . . Reference Biologic Drug
- . . References
- . . Tableofcontents Executivesummary
- . R Dr
- ? Guidelineonclinicalinvestigationofthepharmacokineticsoftherapeuticproteins
- ? Guidelineonriskmanagementsystemsformedicinalproductsforhumanuse
- ? Guidelineonsimilarbiologicalproducts
- ? Ichtopice10-Noteforguidanceonchoiceofcontrolgroupinclinicaltrials
- ? Noteforguidanceongoodclinicalsafetydatamanagement
- A Dr
- A Dr
- A Mrs
- Ahmed
- Dr Kwasi Nyarko
- E Dr
- E G See
- Ema See
- Ema See
- Emea/Chmp/Bwp
- Emea/Chmp/Bwp
- Erika Fisher / King Lietzan
- Food Shacter
- Guidelineonsimilarbiologicalmedicinalproductscontaining . . Biotechnology-Derivedproteinsasactivesubstance:Qualityissues Executivesummary
- H Dr
- H M J Dr
- I Dr
- Ich Q1a
- Ich Q2b Guideline
- Ich Q5a Guideline
- Ich Q5b Guideline
- Ich Q5c Guideline
- Ich Q5d Guideline
- Ich Q5e
- Ich Q5e Guideline
- Ich Q6b
- Ich Q6b Guideline
- Ich S6
- Ich S6 Guideline
- Id
- J Dr
- J Dr
- J Dr
- J Dr
- J Dr
- J Joung
- J Woodcock
- K Dr
- M Dr
- M Dr
- M Ms
- P D Dr
- P Dr
- P J Heim
- Page2
- Page4
- Qualityaspects . Comparabilityexerciseversusreferenceproduct
- R Dr
- R Dr
- Ramsey Baghdadi
- References ? Guidelineonsimilarbiologicalmedicinalproductscontainingbiotechnology
- S Dr
- S Dr
- S Dr
- S Dr
- S Dr
- S Dr
- S Ms
- See Letter From Steven
- Steven K Letter From
- Switzerland
- Y H Mrs
- Yamaguchi Dr Teruhide
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2011
- Field of study