Elective Subject book, notes pdf - b pharmacy 4th year (7th semester) - JNTUH
Elective Subject
(Pharmaceutical Marketing, Pharmaceutical Regulatory Science, Pharmacovigilance, Quality Control and Standardization of Herbals)
Notes | Books | Syllabus | Previous Paper
B Pharmacy 4th year (1st sem) | 7th Semester | JNTUH
.jpg)
Pharmaceutical Marketing
Unit - 1
Marketing
Definition, general concepts, and scope of marketing; Distinction between marketing & selling; Marketing environment; Industry and competitive analysis; Analyzing consumer buying behavior; industrial buying behavior.
Pharmaceutical market
Quantitative and qualitative aspects; size and composition of the market; demographic descriptions and socio-psychological characteristics of the consumer; market segmentation& targeting. Consumer profile; Motivation and prescribing habits of the physician; patients' choice of physician and retail pharmacist. Analyzing the Market; Role of market research.
Unit - 2
Product decision
Meaning, Classification, product line and product mix decisions, product life cycle, product portfolio analysis; product positioning; New product decisions; Product branding, packaging and labeling decisions, Product management in pharmaceutical industry.
Unit - 3
Promotion
Meaning and methods, determinants of promotional mix, promotional budget; An overview of personal selling, advertising, direct mail, journals, sampling, retailing, medical exhibition, public relations, online promotional techniques for OTC Products.
Unit - 4
Pharmaceutical marketing channels
Designing channel, channel members, selecting the appropriate channel, conflict in channels, physical distribution management: Strategic importance, tasks in physical distribution management. Professional sales representative (PSR): Duties of PSR, purpose of detailing, selection and training, supervising, norms for customer calls, motivating, evaluating, compensation and future prospects of the PSR
Unit - 5
Pricing: Meaning, importance, objectives, determinants of price; pricing methods and strategies, issues in price management in pharmaceutical industry. An overview of DPCO (Drug Price Control Order) and NPPA (National Pharmaceutical Pricing Authority).
Emerging concepts in marketing: Vertical & Horizontal Marketing; Rural Marketing; Consumerism; Industrial Marketing; Global Marketing.
Pharmaceutical Regulatory Science
Unit - 1
New Drug Discovery and development
Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept of generics, Generic drug product development.
Unit - 2
Regulatory Approval Process:
Approval processes and timelines involved in Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA) in US. Changes to an approved NDA / ANDA.
Regulatory authorities and agencies
Overview of regulatory authorities of United States, European Union, Australia, Japan, Canada (Organization structure and types of applications)
Unit - 3
Registration of Indian drug product in overseas market
Procedure for export of pharmaceutical products, Technical documentation, Drug Master Files (DMF), Common Technical Document (CTD), electronic Common Technical Document (eCTD), ASEAN Common Technical Document (ACTD) research
Unit - 4
Clinical trials
Developing clinical trial protocols, Institutional Review Board / Independent Ethics committee - formation and working procedures, Informed consent process and procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials, Pharmacovigilance - safety monitoring in clinical trials.
Unit - 5
Regulatory Concepts
Basic terminologies, guidance, guidelines, regulations, laws and acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book
Pharmacovigilance
Unit - 1
Introduction to Pharmacovigilance
a) History and development of Pharmacovigilance
b) Importance of safety monitoring of Medicine
c) WHO international drug monitoring programme
d) Pharmacovigilance Program of India (PvPI)
Introduction to adverse drug reactions
a) Definitions and classification of ADRs
b) Detection and reporting
c) Methods in Causality assessment
d) Severity and seriousness assessment
e) Predictability and preventability assessment
Basic terminologies used in pharmacovigilance:
a) Terminologies of adverse medication related events
b) Regulatory terminologies
Unit - 2
Drug and disease classification
a) Anatomical, therapeutic and chemical classification of drugs
b) International classification of diseases
c) Daily defined doses
Drug dictionaries and coding in pharmacovigilance
a) WHO adverse reaction terminologies
b) MedDRA and Standardized MedDRA queries
c) WHO drug dictionary
Information resources in pharmacovigilance
a) Basic drug information resources
Establishing pharmacovigilance programme
a) Establishing in a hospital
b) Establishment & operation of drug safety department in industry
c) Contract Research Organizations (CROs)
Unit - 3
Vaccine safety surveillance
a) Vaccine Pharmacovigilance
b) Vaccination failure
c) Adverse events following immunization
Pharmacovigilance methods
a) Passive surveillance – Spontaneous reports and case series
b) Stimulated reporting
c) Active surveillance – Sentinel sites, drug event monitoring and registries
d) Comparative observational studies – Cross sectional study, case control study and cohort study
e) Targeted clinical investigations
Unit - 4
Statistical methods for evaluating medication safety data Safety data generation
a) Pre-clinical phase
b) Clinical phase
c) Post approval phase
ICH Guidelines for Pharmacovigilance
a) Organization and objectives of ICH
b) Expedited reporting
c) Individual case safety reports
d) Periodic safety update reports
e) Post approval expedited reporting
f) Pharmacovigilance planning
g) Good clinical practice in pharmacovigilance studies
Unit - 5
Pharmacogenomics of adverse drug reactions:
Drug safety evaluation in special population
a) Pediatrics
b) Pregnancy and lactation
c) Geriatrics
Quality Control and Standardization of Herbals
Unit - 1
Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials and dosage forms. WHO guidelines for quality control of herbal drugs. Evaluation of commercial crude drugs intended for use
Unit - 2
Quality assurance in herbal drug industry of cGMP, GAP, GMP and GLP in traditional system of medicine. WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal Medicines WHO Guidelines on GACP for Medicinal Plants.
Unit - 3
EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
Unit - 4
Stability testing of herbal medicines. Application of various chromatographic techniques in standardization of herbal products.
Preparation of documents for new drug application and export registration GMP requirements and Drugs & Cosmetics Act provisions.
Unit - 5
Regulatory requirements for herbal medicines.
WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems Comparison of various Herbal Pharmacopoeias.
Role of chemical and biological markers in standardization of herbal products
See more----------------------------------------
.jpg)
Comments
Post a Comment