DRUG DISCOVERY DEVELOPMENT (DDD)
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DRUG DISCOVERY DEVELOPMENT (DDD) - Marcador
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DRUG DISCOVERY DEVELOPMENT (DDD) - Detalles
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3 main routes by which drugs were discovered | 1 Chemistry- driven approaches 2 Target-directed approaches 3 Accidental clinical discoveries |
The Regulatory Process concern was poisonous or addictive, not with efficacy and possible harmful effects | Mid-19th century ( 1906 Food and Drugs Act) |
3 main phases of creation of a New Drug: | 1 Drug Discovery - from therapeutic concept to molecule 2 Drug Development - from molecule to registered product 3 Commercialization - from product to therapeutic application to sales |
The Regulatory Process safety must be demonstrated, inspection of manufacturing facilities | 1937 - Diethylene glycol in sulfonamide cause 107 deaths in USA |
The Regulatory Process proven efficacy and safety | 1962: Kefauver-Harris amendment |
Resulting in the isolation of psilocybin from psychoactive mushrooms. | Robert Gordon Wasson [1898–1986] and Albert Hofmann [1906–2008] Wass up Hofmann? |
Resulting in the isolation of psilocybin from psychoactive mushrooms. | Robert Gordon Wasson [1898–1986] and Albert Hofmann [1906–2008] |
They established Molecular Ethnopharmacology. | Luis Lewin [1850–1929], Carl Hartwich [1851–1917], Alexander Tschirch [1856– 1939], Richard Evans Schultes [1915–2001] CARL |
Drugs developed based on ethno pharmacological studies | 1 Aspirin (Bark of willow tree) 2 Artemisinin (Artemisia annua L.; Chinese plant) 3 Quinine (Cinchona; first antimalarial) |
NATURAL PRODUCT DRUG DISCOVERY This involves screening mixtures of compounds obtained from plant extracts or from microbial broths. | Activity profiling of extracts |
A term used generally to describe the legal practice by pharmaceutical companies exploiting the indigenous people’s traditional knowledge of medicine | Pharmaceutical biopiracy |
Models for Studying Diseases | 1 Cell cultures 2 Cross-species studies 3 Bioinformatics 4 Biomarkers 5 Proteomics |
The Regulatory Process concern was poisonous or addictive, not with efficacy and possible harmful effects | Mid-19th century ( 1906 Food and Drugs Act) |
The Regulatory Process safety must be demonstrated, inspection of manufacturing facilities | 1937 - Diethylene glycol in sulfonamide cause 107 deaths in USA |
The Regulatory Process proven efficacy and safety | 1962: Kefauver-Harris amendment |
All new drugs has to be submitted for approval before clinical trials could begin, and before they can proceed to market | 1963: Committee on the Safety of Drugs |
Illegal to proceed with trials without approval | 1968: Medicines Act |
Evidence of efficacy was added to the criteria; evidence of safety, efficacy and chemical purity | 1970 |
Genes and proteins found in humans may also be found in other species. The functions of many human genes have been revealed by studying parallel genes in other organisms. | Cross-species studies: |
Initiates because there is a disease or clinical condition without suitable medical products available. - Examples are rare diseases or orphan diseases. | Drug Discovery and Development |
Various processes in drug discovery: | - Target Identification and Validation - Lead Identification and Optimization - Computer Aided Drug Design - Pre-formulation Studies-include the Challenges TLC P |
Tools for Target Identification | - Genomics - Proteomics - Bioinformatics |
1 Is the most commonly used for RNA interference tool for including short-term silencing of protein coding genes 2 Antisense technology prevent the synthesis of specific protein | 1 siRNA- Small Interfering RNA 2 Antisense Oligonucleotides |
Tools for Target Validation | - siRNA - Antisense Oligonucleotides |
Early Safety Test for the Lead Compound performed in living cells, in animals and via computational models. | ADME/ Tox properties |
- Smaller proteins - gives structural information about binding and dynamics in physiological conditions | NMR (Nuclear Magnetic Resonance) |
Computational Tools for Drug Designing 1 Categories of software | ❖ Databases & Draw Tools ❖ Molecular Modeling & Homology Modeling ❖ Binding site prediction & Docking ❖ Ligand design Screening -QSAR ❖ Binding free energy estimation ❖ ADME Toxicity |
Types of Drug Design | 1. Ligand-based drug design 2. Structure-based drug design |
- It is needed to identify all the solid forms that may exist as a consequence of the synthetic stage such as the presence of polymorphs. | Bulk characters of the drug |
The size of the drug particle can influence its dissolution rate, suspendability and other properties. | Fine particle characterization |
Help you understand the ease with which the drug powder will flow under a set of specific conditions like humidity, pressure and etc | Powder flow properties |
Methods of Solubility analysis include: | ❏ Ionization constant ❏ pH solubility profile ❏ Common ion effect ❏ Thermal effects ❏ Solubilization ❏ Partition coefficient ❏ Dissolution |
Helps to understand the influence of pH on drug solubility, stability, and absorption | PH solubility profile |
Determines the solubility of the drug substance when a solution compound having a common ion with the drug is added to the test solution | Common ion effect |
Helps to evaluate the drug solubility with respect to the changes in the drug temperature of the solvent | Thermal effects |
Is the measurement of the drug lipophilicity or ability to cross a cell membrane. | Partition coefficient |
Three R's in research | 1 Replacement 2 Reduction 3 Refinement |
The USE OF NON SENTIENT MATERIAL TO REPLACE METHODS which use conscious living vertebrates | Replacement |
GOVERNMENT OFFICES | 1 Bureau of Animal Industry (BAI) 2 Philippine Association for Laboratory Animal Science (PALAS) 3 Committee on Laboratory Animal Resources Development and Standardization (LARDS) 4 Protected Areas and Wildlife Bureau (PAWB) 5 Philippine Council for Health Research and Development (PCHRD) |
1 Animal Welfare Act 2 Rules and Regulations on the Conduct of Scientific Procedures Using Animals | 1) R.A. 8485 2) D.A. A.O. No. 40 |
➔ Justified statistically ➔ Alternatives (less invasive procedures, other species, isolated organ preparation, tissue culture, computer models) | Appropriate species, quality, number or animals |
OTHER CONSIDERATIONS | ➢ Veterinary care ➢ Personnel qualifications and training ➢ Personal hygiene ➢ Occupational health and safety of personnel ➢ Hazard Identification and Risk Assessment ➢ Facilities, Procedures and Monitoring ➢ Personal protection ➢ Medical evaluation and preventive medicine for personnel |
CONSIDERATIONS FOR CLINICAL TRIALS | 1st: Pharmacologic profile is equal or better than existing competitors 2nd: Address unmet medical or improve therapy 3rd: Market potential sufficient to sustain profitability 4th: Risk factors are assessed 5th: Potential expenses 6th: Success in the marketplace |
Refers to studies, or trials, that are done in people | Clinical research |
TRIAL OBJECTIVES | Phase I- limited to determining toxicity at a range of dosages Terminal illnesses- efficacy assessment Phase Il and III- Clinical efficacy in large sample of patients Phase IV- Assess efficacy and side effects in specific patient population |
COMPONENTS OF A TRIAL OBJECTIVE | 1 Approach of the trial (to compare; asses and evaluate) 2 Specific disease 3 Types of patients 4 Drug therapy(ies) 5 Dosage |