•  Retrait gratuit dans votre magasin Club
  •  7.000.000 titres dans notre catalogue
  •  Payer en toute sécurité
  •  Toujours un magasin près de chez vous     
  •  Retrait gratuit dans votre magasin Club
  •  7.000.000 titres dans notre catalogue
  •  Payer en toute sécurité
  •  Toujours un magasin près de chez vous

Technology Transfer

Drug Product Manufacturing Process

Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram
Livre relié | Anglais | Aaps Introductions in the Pharmaceutical Sciences | n° 10
147,95 €
+ 295 points
Livraison sous 1 à 4 semaines
Passer une commande en un clic
Payer en toute sécurité
Livraison en Belgique: 3,99 €
Livraison en magasin gratuite

Description

Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance.
This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirements of the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook's authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.

Spécifications

Parties prenantes

Auteur(s) :
Editeur:

Contenu

Nombre de pages :
148
Langue:
Anglais
Collection :
Tome:
n° 10

Caractéristiques

EAN:
9783031321917
Date de parution :
17-06-23
Format:
Livre relié
Format numérique:
Genaaid
Dimensions :
156 mm x 234 mm
Poids :
408 g

Les avis