Biomedical researches, conducted by various organizations are required to be documented in accordance with regulatory and public requirements. Medical writing is a specialized technical writing that generates explicit documents as per standard operating procedures to suit target audience. Various organizations, termed as medical writing agencies share this onus with sponsors by dealing with the services related to both regulatory and commercial conceptualization pertaining to clinical as well as marketing phase.
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Medical Affairs is responsible for developing and implementing medical tactics and strategies for promoting a brand or therapeutic area. Personnel in the medical affairs department work in close association with sales/ marketing and healthcare professionals with a key function to promote brands/products specific scientific and medical information for an organization. Medical affairs manage clinical experts to work for the benefits of pharmaceutical organization by improving scientific knowledge base of a product, a discipline called key opinion leaders management (KOL management). Medical affairs involve arranging scientific conferences, organising educational and medical events for healthcare professionals or advisory bodies and plan research programmes and publication strategies.
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Different countries and regions across the globe witness varied patterns in drug effects and reactions. This occurs due to differences in diseases, genetics, diet, prescribing practice, local traditions and drug manufacturing process impacting its quality. Few of these effects are untoward and noxious termed as adverse events. Such events are unwelcomed not only for patients but also for manufactures. Since, regulatory authorities keep a close eye on these occurrences even after the marketing approval of a drug and may take preventive steps to ensure public safety which might even include withdrawal of drug from market.
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As soon as a potential moiety is identified it is subjected to pre-clinical studies for determination of safety, efficacy, pharmacokinetic and pharmacodynamic profiles of molecule which are later extrapolated to human volunteers or clinical subjects under clinical research. Clinical research is carried out meticulously at academic blocks, healthcare organizations and research study centers affiliated by regulatory bodies.
Clinical research, in a systematic and orderly manner investigates the biological properties of investigational product in humans through various steps/phases, traditionally phase I-IV and seldom involving phase 0 and V also.
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Preclinical or nonclinical studies, is a stage of drug development process which begins prior to the humans testing of investigational drug (Clinical trials). Preclinical studies approve or reject thein silico conceptions of drug’s efficacy in biological system. Preclinical studies are conducted in animals to explore the early efficacy of investigational product through pharmacodynamics and kinetics testing. Moreover, thorough investigation of drug’s safety is performed which includes organ system toxicity, besides potential hazards of carcinogenicity, mutagenicity, and teratogenicity. The preclinical findings form the basis of clinical research and allow researchers to estimate a safe starting dose for human testing.
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