Springer Nature
The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals-image

The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals

Leggi la descrizione completa
Miglior prezzo disponibile
199,99$
Springer Nature · Spedizione gratuita
Vedi Offerta
Prezzi aggiornati
Specifiche
MarcaSpringer Nature
CondizioneNuovo
Descrizione
This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)

Storico prezzi

Ricevi una notifica se il prezzo scende

Ti invieremo un'email quando il prezzo di questo prodotto diminuirà.

  • Aggiornamenti dei prezzi in tempo reale
  • Oltre 50 negozi monitorati
  • Avvisi gratuiti di calo prezzo
  • Solo negozi verificati

Avvisami quando il prezzo scende sotto: 199,99$

Ho letto e accettato i informativa sulla privacy.

Prodotti simili

Una selezione di prodotti che potrebbero interessarti. Guarda tutti

The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals 219,99$ The Changing Function Of Compliance A Handbook To Managing Regulatory Risk | Business 50,39$ The Gdpr Challenge Privacy Technology And Compliance In An Age Of Accelerating Change | Science Publishers 96,79$ Beyond The Rhetorics Of Compliance 39,99$ The Comparative Physiology Of Regulatory Peptides 54,99$ The Mortality Costs Of Regulatory Expenditures 109,99$ Defining The Limits Of Outer Space For Regulatory Purposes 54,99$ Regulatory Risk And The Cost Of Capital 109,99$