Drug Development Roadmap (Paperback)

Lingua: inglese

Editore: Independently Published, 2025

9798284006979

Serie: Libro 1 di 50 - Pharmaceutical Industry

Da: CitiRetail, Stevenage, Regno UnitoCitiRetail

Venditore con 5 stelle

Venditore AbeBooks dal 29 giugno 2022

Brossura

Condizione: Nuovo

EUR 17,06

EUR 43,80 spedizione 
Spedito da Regno Unito a U.S.A.

Quantità: 1 disponibile

Aggiungi al carrello
Resi gratuiti per 30 giorni

Descrizione dell’articolo da parte del venditore

Paperback. Drug Development Roadmap: From Lab Bench to Pharmacy Shelf is a comprehensive, real-world guide to the full lifecycle of pharmaceutical development-from early discovery to commercial launch. Written for scientists, regulatory professionals, formulation experts, and industry newcomers, this resource demystifies the drug development process with clarity and technical depth.Drawing from more than two decades of global industry experience, author Mirela Gorjanu presents a step-by-step framework that spans target identification, preclinical studies, GMP manufacturing, analytical method development, clinical trials, regulatory submissions, and post-marketing surveillance.With Cardiovex-a fictitious case study drug-woven throughout, the book bridges theoretical concepts with practical execution, covering topics such as: Analytical method development (HPLC, LC-MS/MS, dissolution)GMP scale-up, packaging, and stability strategyClinical trials, bioequivalence, and regulatory submission formats (CTD/eCTD)Risk management, pharmacovigilance, and lifecycle controlChange control, serialization, and global pharmacy launch planningAligned with ICH, FDA, EMA, and WHO standards, this reference equips readers to navigate complex regulatory environments and build quality into every phase of development. Whether you're launching a new molecule or reformulating a generic, this roadmap delivers the insights and tools needed to accelerate innovation while ensuring compliance and patient safety. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.…

Codice articolo 9798284006979

Titolo
Drug Development Roadmap (Paperback)
Autore
Mirela Gorjanu
Editore
Independently Published
Anno di pubblicazione
2025
Condizione
new
Rilegatura
Paperback
Lingua
inglese
ISBN 13
9798284006979
Serie
Libro 1 di 50: Pharmaceutical Industry

CitiRetail

Stevenage, Regno Unito

Venditore con 5 stelle

Venditore AbeBooks dal 29 giugno 2022

Tariffe di spedizione da Regno Unito a U.S.A.

ArticoloDa 7 a 14 giorni lavorativiDa 7 a 60 giorni lavorativi
Primo articoloEUR 43,80EUR 43,80
I tempi di consegna sono stabiliti dai venditori e variano in base al corriere e al paese. Gli ordini che devono attraversare una dogana possono subire ritardi e spetta agli acquirenti pagare eventuali tariffe o dazi associati. I venditori possono contattarti in merito ad addebiti aggiuntivi dovuti a eventuali maggiorazioni dei costi di spedizione dei tuoi articoli.

Metodi di pagamento

  • Visa
  • Mastercard
  • American Express
  • Carte Bleue
  • Apple Pay
  • Google Pay

Descrizione dello Store

Online business

Informazioni sull’azienda del venditore

ABC BOOKS LIMITED

10 John Street
London, Regno Unito WC1N 2EB