Yeemak Siwoo Interview Questions and Answers

pKa, LogP, and method development validation parameters are important in research associate work.

• pKa is a measure of acid strength and is important in drug design.

• LogP is a measure of lipophilicity and helps predict drug absorption and distribution.

• Method development validation parameters ensure accuracy and reliability of analytical methods.

• Examples of validation parameters include specificity, accuracy, precision, and linearity.

• These parameters are necessary to ensure the q...read more

PPM is a unit of concentration, parts per million. To convert it to mg/ml, you need to know the molecular weight and density of the substance.

• PPM is a measure of the concentration of a substance in a solution.

• It represents the number of parts of a substance per million parts of the solution.

• To convert PPM to mg/ml, you need to know the molecular weight and density of the substance.

• The formula for conversion is: mg/ml = (PPM x molecular weight) / (1000 x density)

The latest changes in bio analytical guidelines focus on improving accuracy and reproducibility of results.

• The FDA released new guidance on bioanalytical method validation in December 2018.

• The EMA updated their guidelines on bioanalytical method validation in June 2019.

• There is a growing emphasis on the use of fit-for-purpose assays and the importance of matrix effects.

• There is also a focus on the use of quality control samples and the need for robust data analysis.

• Overall, t...read more

Medical writing involves creating content for healthcare professionals and patients. Clinical trials are research studies to test new treatments.

• Medical writing involves creating documents like regulatory submissions, clinical study reports, and patient education materials.

• Clinical trials are research studies that test the safety and effectiveness of new treatments or interventions.

• Phases of clinical trials include Phase 1 (safety and dosage), Phase 2 (efficacy and side effec...read more

Medical writing involves creating scientific documents that communicate complex medical information to various audiences.

• Medical writers create documents such as clinical trial reports, regulatory submissions, and scientific manuscripts.

• They must have a strong understanding of medical terminology and scientific research methods.

• Medical writers often work closely with researchers, physicians, and other healthcare professionals to ensure accuracy and clarity in their writing.

• Th...read more

IB stands for Investigator's Brochure. It is a document that provides essential information about the investigational product.

• IB is a comprehensive document that contains information about the drug's composition, pharmacology, toxicology, and clinical data.

• It is prepared by the sponsor and is updated throughout the clinical trial.

• The IB serves as a reference for investigators and regulatory authorities to ensure the safe and ethical conduct of the trial.

• It helps the clinical ...read more

Protocol writing involves several steps, including planning, drafting, reviewing, and finalizing.

• Identify the research question and study design

• Develop a detailed protocol outline

• Draft the protocol, including all necessary sections

• Review and revise the protocol with input from all stakeholders

• Finalize the protocol and obtain necessary approvals