0
Your cart

Your cart is empty

Browse All Departments
  • All Departments
Price
  • R2,500 - R5,000 (1)
  • -
Status
Brand

Showing 1 - 1 of 1 matches in All Departments

Drug Product Manufacturing Process - Technology Transfer (1st ed. 2023): Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip,... Drug Product Manufacturing Process - Technology Transfer (1st ed. 2023)
Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram
R4,177 Discovery Miles 41 770 Ships in 10 - 15 working days

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.

Free Delivery
Pinterest Twitter Facebook Google+
You may like...
Casio LW-200-7AV Watch with 10-Year…
R999 R884 Discovery Miles 8 840
Alcolin Cold Glue (125ml)
R46 Discovery Miles 460
LocknLock Pet Dry Food Container (1.6L)
R109 R91 Discovery Miles 910
Mellerware Aquillo Desktop Fan (White…
R597 Discovery Miles 5 970
Bostik Clear on Blister Card (25ml)
R38 Discovery Miles 380
Bantex @School 13cm Kids Blunt Nose…
R16 Discovery Miles 160
Bestway Hydro-Swim Squiggle Wiggle Dive…
R62 Discovery Miles 620
Aerolatte Cappuccino Art Stencils (Set…
R110 R95 Discovery Miles 950
Dare To Believe - Why I Could Not Stay…
Mmusi Maimane Paperback R350 R249 Discovery Miles 2 490
Loot
Nadine Gordimer Paperback  (2)
R398 R330 Discovery Miles 3 300

 

Partners