The US Food and Drug Administration (FDA) on 11 May made available an International Council for Harmonisation’s (ICH) guideline on post-approval changes for drug products and issued four other final ICH documents and one draft guidance.
The ICH Q12 guideline aims to facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances and is the same as the version endorsed by ICH as a step 4 document in November 2019. More Info >>>
Cell Permeability Market Forecasts
The market for ADME cell permeability testing is growing at CAGR of almost 10% per year according to a number of studies published in the past couple of years. Here a are a few examples:
- According to a recent Roots Analysis study – the US Food and Drug Administration (USFDA), only 9% of investigational new drug (IND) candidates progress beyond the NDA point as a result of unacceptable safety and efficacy profiles. As a result, ADME studies are considered to be critical in establishing the safety and efficacy of drug candidates. That market is growing at CAGR of almost 10% per year according to a number of studies published in the past couple of years. More Info >>>
- According to Grand View Research, their recent report on Evaluation of Drug Transport in MDCKII-Wild Type, MDCKII-MDR1, MDCKII-BCRP and Caco-2 Cell Lines indicates the global ADME toxicology testing market size was valued at USD 4.33 billion in 2017 and is expected to register a CAGR of 11.4% a year through 2024. More Info >>>
- According to Transparency Market Research’s recent study on In Vitro ADME Testing Services Market- Global Industry Analysis, they found the vitro ADME testing services market is anticipated to witness substantial growth and expand at a promising CAGR across the assessment period of 2020-2030. More Info >>>
- Alchemy Market Research says the major factors which are driving the growth of the in-vitro ADME services market are growing investment in research & development activities by pharmaceutical industry which have reached over US$ 165.0 billion in 2018. The market is anticipated to witness substantial growth. More Info >>>