Pharma Digests
The Influence of AI and ML on Clinical Trials
The influence of AI (Artificial Intelligence) and machine learning (ML) on clinical trials is transformative, reshaping numerous facets of the process. Here are some crucial areas where AI and ML are making notable contributions: Patient Recruitment and Retention AI algorithms can efficiently analyze large datasets to identify potential trial participants. ... Read More
AI and ML Challenges in Drug Development
The pharmaceutical industry stands at a critical juncture. Despite significant advances in scientific understanding and technology, the process of drug development remains stubbornly inefficient, expensive, and prone to failure. It takes an average of 10-15 years and costs over $2.6 billion to bring a single new drug to market, with ... Read More
AI/ML Opportunities in Drug Development
Artificial intelligence and machine learning offer promising solutions to many of the challenges faced in traditional drug development. Here, I explore the potential applications of AI/ML across the drug development pipeline: 1. Target Identification and Validation a) Multi-omics data integration: AI algorithms can integrate and analyze vast amounts of genomic, ... Read More
How to Design Forced Degradation Studies?
Most Forced degradation studies are started with a generic checklist: acid, alkali, peroxide, heat, light etc. But forced degradation is not about “covering conditions.” It is about understanding how your drug product is actually likely to break down. Here’s a practical way to approach it: 𝗦𝘁𝗲𝗽 𝟭: 𝗚𝗮𝘁𝗵𝗲𝗿 𝗽𝗿𝗶𝗼𝗿 𝗸𝗻𝗼𝘄𝗹𝗲𝗱𝗴𝗲 ... Read More
Artificial Intelligence and Design of Experiments
Artificial Intelligence (AI) is transforming this landscape by complementing traditional QbD and DoE approaches rather than replacing them. The true power of AI lies in its ability to analyze large volumes of historical formulation, process, dissolution, stability, and bioequivalence data to identify patterns that may not be immediately apparent to ... Read More
Worst-Case Product in Cleaning Validation
Product grouping is a way to reduce validation activities in sites with multiple products and processes. Products may be grouped together if they are cleaned by the same process. If a product in that group requires a more aggressive cleaning process, that product becomes the worst-case product in that group. ... Read More
Impact of Genomic Variation on Drug Response
The impact of genomic variation on drug response may require investigation in clinical studies. For genomic variation that may affect the PK of a medicinal product, clinical studies should be designed in accordance with the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products. Genetic ... Read More
DNA Analytics for Genomic Study
A variety of protocols are available for the extraction of gDNA from different sources. It is important to employ a validated method leading to an isolation of gDNA of highest quality, suitable for the nucleotide variation analysis (single or array-based qPCR or end-point PCR), and for sequencing (Sanger, NGS). It ... Read More
Sample Acquisition and Handling During Genomic Study
Identification of genetic variants demands high quality genomic DNA (gDNA). Pre-analytical variations in (i) sample collection, (ii) stability, (iii) sample labelling, (iv) transport to the site of analysis, (v) tissue/sample processing and (vi) storage, should be minimized throughout the workflow to guarantee the highest possible sample quality (see guideline ICH ... Read More
Specific Issues for HLA Alleles
Idiosyncratic adverse drug reactions (ADRs) include examples of strong associations between genotypes and drug responses. These reactions: It is therefore recommended to collect DNA for later HLA typing in a drug developmental program to identify possible useful predictive HLA biomarkers. A comprehensive database listing ADRs associated with the HLA alleles ... Read More
Phenotype and Genotype Correlations
Genetic variants may influence the function of a gene: The PK-phenotype can also be determined by multiple variations in different alleles, e.g. for medicinal products metabolized by multiple pathways. The detection of specific genetic variants in clinical routine helps to improve efficacy and safety of specific medicinal products in use, ... Read More