Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

Documentation 105

Documentation Drug Development Communication 105

Express Pharma

OCTOBER 19, 2024

Arora explains that pharma associations like the Indian Pharmaceutical Association (IPA) organise training and development programmes through sessions, workshops, and webinars focused on the latest trends and technologies in R&D. References [link] [link] 281%29.pdf

Drug Development 110

Drug Development Documentation 110

Pharmaceutical Technology

OCTOBER 28, 2022

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Since most biologics and biosimilars are large molecules, they may prove challenging to develop and manufacture on the large scale.

Biosimilars 52

Biosimilars Vaccines Drug Development Documentation 52

Putting Patients First Blog

APRIL 14, 2023

Driven by the work of the Food and Drug Administration on patient-focused drug development (PFDD), many companies in the biopharmaceutical community have devoted significant resources to better understand patient populations and are working to bring to market products that best suit their needs. Sincerely, Randall L.

Drug Pricing 40

Drug Pricing Drug Development Documentation Communication 40

Pharmaceutical Technology

NOVEMBER 28, 2022

To learn more about the development and partnership opportunities for businesses within Scotland’s health sector, download the document on this page. Precision Medicine: Streamlining Treatments and Drug Development. Free Whitepaper.

Hospitals 52

Hospitals Packaging Medical Schools Documentation 52