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“BLIND-SPOTS” OF MEDICINE LIFE-CYCLE FROM THE POINT OF VIEW OF THE GOOD PRACTICES

“BLIND-SPOTS” OF MEDICINE LIFE-CYCLE FROM THE POINT OF VIEW OF THE GOOD PRACTICES. Phase I. Preclinical studies. MEDICINE LIFECYCLE. ?. Discovery. GCP. Preclinical studies. Approval. Clinical studies. Phase IV. GLP. Manufacturing, Marketing. Post-approval studies. GMP. Phase II. ?.

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“BLIND-SPOTS” OF MEDICINE LIFE-CYCLE FROM THE POINT OF VIEW OF THE GOOD PRACTICES

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  1. “BLIND-SPOTS” OF MEDICINE LIFE-CYCLE FROM THE POINT OF VIEW OF THE GOOD PRACTICES

  2. PhaseI Preclinical studies MEDICINELIFECYCLE ? Discovery GCP Preclinical studies Approval Clinical studies PhaseIV GLP Manufacturing, Marketing Post-approval studies GMP PhaseII ? Animal welfare PhaseIII ? Pharmaceutical development ?

  3. GOOD PRACTICE IN FUNDAMENTAL STUDIES ≈20% of all preclinical studies in Russia HANDBOOK ON QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH (QPBR) • in vitro, insilico screening • Search for mechanisms of action • Pharmacological properties in vitro/in vivo • Pharmacokinetics • ADME TOX • Prior toxicity studies Validation equipment Study director Controls Quality Assurance GLP-like Study plans preparation SOP Reporting documentation

  4. ARE POST-APPROVAL STUDIES GLP orNON-GLP? ≈70% of all preclinical studies in Russia • Changing composition of excipients • Changing manufacturing facility API • New efficient reception • Changing course of use • Establishing/evidence of the mechanism of action • Clarification of toxic properties • Adding the usage at pregnancy into instruction BIOSIMILARS GENERICS Pre(“Non”)clinical stydies HYBRID MEDICINES

  5. LABORATORY ANIMALS Good animalwelfare practice? Animal environment Methods of euthanasia Humanity of manipulations Animal housing Feeding and watering RUS-LASA Animal number used in study Enrichment of living environment https://www.ufaw.org.uk Pain and stress

  6. PHARMACEUTICALDEVELOPMENT Pharmaceutical dosage form Manufacturing Packaging materials Medicine compounds Choice of API (concentration, physical state and size of counts) Choice of pharmaceutical dosage form Technological methods Choice of material types, size and package Functional properties of a pharmaceutical dosage form Functional properties of a commercial product Choice of excipients Establishing product expiration date into package • Solvents • Basis • Shells • Preservatives • Release modifiers • Parametersof • (PHARMACOPOEIA) • Biological activity • Stability • Sterility and etc. • Abnormal toxicity ISO 17025 GMP GLP

  7. QUALITY MANAGEMENT SYSTEMS COOPERATING ISO 9001 Process-oriented Quality Management Product-oriented Quality Management GXP GCP GMP GSP ISO 17025 GLP Quality Management Systems ISO 9001

  8. THANK YOU FOR LISTENING www.doclinika.ru info@doclinika.ru 188663, Ленинградская область , Всеволожский район, гп Кузьмоловский, ул. Заводская, д. 3, к. 245

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