How to study this subject

UNIT 1:
DRUG MANUFACTURE AND FORMULATION
Introduction to pharma industry, Biotechnology and Drug design, Basic concepts and applications, composition, preparation, physicochemical considerations in manufacture of
current biotech products & herbal medicines. Need of formulation and formulation development considerations. Concept & testing of preformulations & their parameters. Tablets: compressed, granulation, coatings, pills, capsules. Parental preparations, herbal extracts, Oral liquids, Ointments. Overview of Process Validation for pharmaceutical industries, Pilot Plant, Scale-Up Techniques. 08 Hours

UNIT 2:
ANALYSIS OF PHARMACEUTICALS
Analytical methods and tests for various drugs -Physicochemical and bioanalytical considerations. Validation of analytical methods. packaging techniques- Glass containers,
plastic containers, film wrapper, bottle seals; Quality assurance and control- storage and stability of biotech products. 04 Hours

UNIT 3:
PHARMACOKINETICS AND PHARMACODYNAMICS
Pharmacodynamics and Pharmacokinetics of protein based drugs. Basic concepts, ADME definitions , Need of pharmacokinetic study. Interpretations from pharmacokinetics parameters. Examples of Pharmacodynamic parameters of various drugs. Evolution of Drug Metabolism Phase I Metabolism (microsomal oxidation, hydroxylation, dealkylation) Phase II Metabolism (Drug conjugation pathway) CYP Families. 07 Hours

UNIT 4:
PHARMACOTHERAPY
Classification of drugs based on therapeutic actions using suitable examples Special emphasis on Vitamins, cold remedies, laxatives, analgesics, non-steroidal contraceptives, external antiseptics, antacids, antibiotics, biologicals, herbal products. Pharmacotherapy of migraine, cancer, TB, diabetes and male sexual dysfuntion. Hormone replacement therapy. 07 Hours

PART-B

UNIT 5:
CLINICAL BIOTECHNOLOGY
The philosophy behind and organization of clinical research. Disease target identification and selection, receptor-based approaches, agonists, antagonists, enzyme inhibitors, Pre-clinical development to support testing in humans: In vitro and in vivo testing of new compounds, Relationship between animal and human pharmacology. Safety testing – acute, sub acute toxicology, immunotoxicology. Concepts of pharmacovigilance. 07 Hours

UNIT 6:
BIOTHERAPY
Biotherapeutics: Clinical importance of Therapeutic Proteins: Therapeutic Antibodies and Enzymes; Hormones and Growth Factors used as therapeutics (erythropoietin & insulin as examples). Interferons, Interleukins and additional Regulatory Factors. Preservation and clinical use of blood and blood components, principles and safety guide lines for blood transfusion. Advanced Sustained Release, Advanced drug Delivery Systems: Liposomes and Nanoparticles, biodegradable drug delivery system (hydrogel based). 08 Hours

UNIT 7:
STEM CELLS IN HEALTH CARE
Types and identification of stem cells, Fate Mapping of Stem Cells, Use of stem cells in therapy of neurological, hematopoetic, hepatic, pancreatic disorders. Applications of epidermal stem cell in Tissue engineering. Hematopoietic Stem Cells, Classification and clinical manifestations of hematopoietic stem cell disorders. 06 Hours

UNIT 8:
CLINICAL RESEARCH
General principles and guide to data sources, types of epidemiology study designs, ecological (correlation) studies, case reports, prevalence surveys or cross-sectional studies, case control studies, Clinical trials-informed consent, Placebo Responses, Clinical Registries. Clinical Research Institutes, Data Management, Clinical Research from Pharmaceutical Industry Perspective. 05 Hours

TEXT BOOKS
https://pharmareview.files.wordpress.com/2015/03/biopharmaceuticals-biochemistry-and-biotechnology-walsh-wiley-2e-2003.pdf
Principles and Practice of Clinical Research by J. I. Gallin and F. P. Ognibene, Elsevier Publication.
Hematology by William J. Williams, Ernest Beutler, Allan JU. Erslev, Marshall A. Lichtman, IK Publishers.
Stem Cell Biology by Marshak, Cold Spring Harbour Symposium Pulblications.
Current Trends in Pharmacology by Arunabha Ray & Kavitha Gulati, IK Intl.
An Introduction to Synthetic Drugs by Singh & Rangnekar, Himalaya publishing House.
Biopharmaceuticals, Biochemistry and Biotechnology by Gary Walsh, Wiley Pub.
Principles of Medicinal Chemistry by Foye, Lippincott Williams & Wilkins Publishers.
Industrial Pharmaceutical Biotechnology by Heinrich Klefenz, Wiley-VCH edition.
Biopharmaceutical Drug Design and Development by S Wu-Pong, Y Rojanasakul, and J Robinson.
Pharmaceutical Biotechnology by K Sambamurthy & Ashutosh Kar, New Age.
Pharmaceutical Biotechnology by S P Vyas and V K Dixit, CBS Publishers.

REFERENCE BOOKS
Basic & Clinical Pharmacology by Bartram G. Katzung, Mc Graw Hill.
The Theory & Practice of Industrial Pharmacy by Leon Lachman, Herbert A. Lieberman &
Joseph & Kanig, Vergese Publishing House Bombay.
Enzyme Technologies for pharmaceutical and biotechnological applications by Herbert A Kirst,
Wu-Kuang Yeh, Milton J. Marcel Dekker Publications.
Developmental Biology, by Scott F. Gilbert, Wiley Publications.
Current Trends in Pharmacology by Arunabha Ray & Kavitha Gulati, IK Intl.
Developmental Biology, Scott F. Gilbert, Cambridge University Press.
Molecular Biology of the Cell, by Bruce Alberts, Dennis Bray, Julian Lewis, Martin Raff, Keith Roberts, James D. Watson, Garland Science.
Text book of Medical Biochemistry by R L Nath, New Age Publishers.
Pharmaceutical Biotechnology by K Sambamurthy & Ashutosh Kar, New Age Publishers.
ICH guideline Q6B, Freelance Publishing.
Basic & Clinical Pharmacology by Bartram G. Katzung, Mc Graw Hill.

Official Notes

Notes from other sources

Model question papers

Previous year question papers

Useful links