Study Capabilities
Analytical & Physical Chemistry
Analytical Chemistry:
Perform dose formulation, stability, and homogeneity analyses to ensure accuracy and consistency using validated HPLC and LC-MS assay.
Guidelines: ICH Q2(R1), OECD GLP Principles, USP <1225>.
Physical chemistry:
These studies characterize the physicochemical properties of drug substances and formulations. It evaluates parameters which are critical for predicting absorption, safety, and shelf life
Basic Physical Properties : Determine key material traits including physical state, color, pH, viscosity, and thermal characteristics.<BR>
Guidelines: OECD Test Guidelines (TG) 102 (Melting Point), TG 103 (Boiling Point), ISO 787 series (Color), ISO 3104 (Viscosity), ASTM E70 (pH measurement).
> Stability and safety related properties :
Assess long-term storage stability and key safety parameters like flash point and flammability.
Guidelines: OECD TG 101 (Flash Point), OECD TG 117 (Partition Coefficient), ISO 10456 (Stability), ASTM D93 (Flash Point).
> Solubility and
partitioning:
Evaluate solubility profiles and partition behavior in water and organic solvents (Log P, miscibility)
Guidelines: OECD TG 105 (Water Solubility), OECD TG 107 and 117 (Partition Coefficient), ISO 2811 (Density)
> Formulation characterization :
Measure formulation performance attributes including emulsion stability, suspensibility, and dustiness.
Guidelines: OECD TG 318 (Suspensibility), ISO 12103 (Dustiness), ASTM D4740 (Emulsion Stability).
> Chemical reactivity :
Analyze surface tension, corrosion potential, dissociation constants, and moisture-related reactivity.
Guidelines: OECD TG 112 (Dissociation), ISO 9227 (Corrosion Testing), ASTM D1293 (pH), ISO 787-4 (Acidity).
Pharmacology Studies
These studies investigate the therapeutic effects and mechanisms of action of drug candidates through in vitro and in vivo models. It is essential for demonstrating pharmacodynamic activity, dose-response relationships, and target engagement, forming the scientific basis for efficacy before clinical trials
Drug Metabolism & Pharmacokinetics (DMPK)
Conduct bioanalysis of blood and tissue samples to evaluate drug absorption, distribution, metabolism, and excretion.
Efficacy Studies Using Bioanalytical Assays
Measure pharmacodynamic responses and potency through validated biological assays.
- FSH & LH Bioassays (Urofollitropin, Menotropin)
Determine effect on follicle-stimulating and luteinizing hormone activity in compliance with IP, BP, and USP standards.
- HCG Bioassay
Assess the potency and biological activity of Human Chorionic Gonadotropin using pharmacopeial methods.
- Erythropoietin Bioassay (EP)
Quantify the bioactivity of erythropoietin to support efficacy testing.
- Insulin Biopotency Test (USP)
Evaluate insulin’s pharmacological strength in accordance with USP guidelines.
- Insulin Bioidentity Test (USP)
Confirm the identity and consistency of insulin formulations through USP-compliant assays.
- Heparin & Enoxaparin Anti-Xa/IIa Activity
Measure anticoagulant potency via chromogenic substrate assays targeting Factor Xa and IIa.
Specific bioassays for hormones and biologics (e.g., FSH, LH, HCG, Erythropoietin, Insulin, Heparin) are guided by respective pharmacopeial standards (USP, EP, BP, IP) rather than OECD or ICH guidelines.
Animal studies: Rat, Mice, Nude Mice, Rabbits, Guinea Pigs:
Route of administration: Oral, Intravenous, Intradermal, Intraperitoneal, Intramuscular, Topical, Ocular, Intraocular, Intravitreal, Intracorneal, Intratracheal, Sublingual in rabbits.
Disease models:
Ulcer Models, Xenograft Models, Colitis Models, Diabetes Models, Infection Models, Chemically Induced Disease Models Utilize various animal models to study disease mechanisms and evaluate therapeutic interventions.
Guidelines: Based on verified scientific literature.
Toxicology Studies
Toxicology studies are conducted to assess the potential harmful effects of pharmaceutical, chemical, or biological substances on living systems. These studies are crucial for determining safe dosage ranges and identifying any adverse effects before clinical trials.
In Vitro Toxicology Studies
| No. | Study | Description | Guidelines |
|---|---|---|---|
| 01 | Eye Irritation Tests | Assess ocular irritation potential using reconstructed human cornea-like epithelium models. | OECD 439, 492 |
| 02 | Skin Irritation and Corrosion Tests | Assess dermal irritation and corrosion using reconstructed human skin-like epithelium models. | OECD 439, 492 |
| 03 | Cytotoxicity Assays | Evaluate cell viability and membrane integrity to determine cytotoxic potential. | ISO 10993-5 |
| 04 | Phototoxicity Assays | Evaluate phototoxic potential of photoreactive compounds using monolayer and reconstructed epithelium models. | OECD 432, 498 |
In Vivo Toxicology Studies
| No. | Study | Description | Guidelines |
|---|---|---|---|
| 01 | Dose Range Finding & Maximum Tolerated Dose (MTD) Studies | Determine appropriate dosing levels for subsequent toxicity studies. | OECD TG 407, 408 |
| 02 | Single and Repeated Dose Toxicity Studies | Assess systemic toxicity following single or multiple exposures through oral, dermal, and inhalation routes, supported by histopathological assessment. | OECD TG 407, 408, 410, 411 |
| 03 | Chronic Toxicity Studies | Evaluate long-term toxic effects of substances on health and well-being over an extended period. | OECD TG 452 |
| 04 | Acute Dermal Toxicity | Assess systemic toxicity following a single dermal application to determine safety classification and dose thresholds. | OECD 402 |
| 05 | Inhalation Toxicity | Evaluate acute effects following inhalation exposure to assess respiratory toxicity and hazard classification. | OECD 403 |
| 06 | Acute Dermal Irritation | Determine the potential to cause skin irritation or corrosion following short-term dermal contact. | OECD 404 |
| 07 | Acute Eye Irritation | Assess the potential of chemicals or formulations to cause eye irritation or serious damage. | OECD 405 |
| 08 | Skin Sensitisation | Evaluate the potential to induce skin sensitization after repeated dermal exposure. | OECD 406 |
| 09 | Repeated Dose 28-Day Oral Toxicity | Determine toxic effects of daily oral exposure over 28 days, identify target-organ toxicity, and establish NOAEL. | OECD 407 |
| 10 | Repeated Dose 90-Day Oral Toxicity | Assess sub-chronic toxicity following daily oral administration for 90 days to support regulatory safety evaluations. | OECD 408 |
| 11 | Acute Oral Toxicity (Fixed Dose Method) | Evaluate acute oral toxicity using a fixed-dose approach to estimate lethal-dose thresholds. | OECD 420 |
| 12 | Acute Oral Toxicity (Acute Toxic Class Method) | Determine acute oral toxicity using stepwise dosing to classify hazard potential. | OECD 423 |
| 13 | Carcinogenicity Studies | Investigate the potential of substances to induce cancer. | OECD TG 451, 453 |
| 14 | Reproductive and Developmental Toxicity Studies | Examine effects on reproduction and development, including two-generation studies. | OECD TG 421, 414, 443 |
| 15 | Irritation and Sensitization Studies | Assess the potential to cause skin, mucous membrane, or eye irritation and sensitization. | OECD TG 405, 429, 442B |
| 16 | Immunotoxicity Studies | Evaluate immune responses, including cytokine profiling and antibody production. | ISO 10993-20 |
| 17 | Pyrogen Testing | Detect endotoxins and pyrogenic substances that may cause fever. | USP <151>, USP <85> |
| 18 | Biocompatibility Studies | Assess compatibility of materials with biological systems through intramuscular, subcutaneous, bone, and ocular implantations. | ISO 10993 series |
Genotoxicity & Mutagencity
Mutagenicity studies are designed to detect genetic mutations that may be induced by a substance. These studies form a key part of genotoxicity testing and help assess the potential for DNA damage.
In Vitro Studies
Assess cellular toxicity to screen compound safety in early development stages.
| Study | Guidelines |
|---|---|
| Cell Viability Assays (Qualitative & Quantitative) | ISO 10993 series |
Mutation Tests
Detect gene-level mutations to assess potential mutagenic risks using various in vitro assays.
| Study | Guidelines |
|---|---|
| Bacterial Reverse Mutation Test (Ames Test) | OECD TG 471 |
| Mouse Lymphoma Assay (TK6 Assay) | OECD TG 490 |
| HPRT Assay (Cell Gene Mutation) | OECD TG 476 |
| Mammalian Cell Micronucleus Test | OECD TG 487 |
| Cell Gene Mutation Test | OECD TG 476 |
| Chromosomal Aberration Test | OECD TG 473 |
| Comet Assay | OECD TG 489 |
| Mouse Lymphoma Assay | OECD TG 490 |
| Micronucleus Test | OECD TG 487 |
In Vivo Studies
| No. | Study | Description | Guidelines |
|---|---|---|---|
| 01 | Mammalian Erythrocyte Micronucleus Test | Detects chromosomal damage in bone marrow or peripheral blood erythrocytes of rodents. | OECD TG 474 |
| 02 | Mammalian Bone Marrow Chromosome Aberration Test | Assesses structural chromosomal aberrations in bone marrow cells following in vivo exposure. | OECD TG 475 |
Biocompatibility Studies
Evaluate the safety of medical devices by assessing their potential to cause irritation, sensitization, cytotoxicity, or systemic toxicity.
| No. | Study | Description | Guidelines |
|---|---|---|---|
| 01 | Guinea Pig Maximization Test | Evaluates a material’s potential to cause delayed hypersensitivity reactions using an enhanced sensitization protocol in guinea pigs. | ISO 10993-10:2021 |
| 02 | Intracutaneous Reactivity Test in New Zealand White Rabbits | Assesses localized tissue irritation responses following intracutaneous injection of extracts in rabbits. | ISO 10993-23:2021 |
| 03 | Skin Irritation Test in New Zealand White Rabbits | Determines the potential of a material or extract to cause dermal irritation upon direct skin exposure. | ISO 10993-23:2021 |
| 04 | Pyrogen Studies | Evaluates febrile responses to detect pyrogenic contaminants in medical device extracts or injectable products. | ISO 10993-11:2017 & USP <151> |
| 05 | Skin Sensitization – Buehler Test | Assesses the potential of materials to cause contact sensitization following repeated dermal exposure in guinea pigs. | ISO 10993-10:2021 |
| 06 | Oral Mucosa Irritation Test | Determines the irritation potential of materials when in contact with the oral mucosal tissue. | ISO 10993-23:2021 |
| 07 | Hemolysis by Direct Method | Evaluates direct contact-induced red blood cell lysis to assess blood compatibility. | ISO 10993-4:2017 & ASTM F756 |
| 08 | Hemolysis by Indirect Method | Assesses hemolytic effects caused by extractable substances from medical devices when incubated with blood. | ISO 10993-4:2017 & ASTM F756 |
| 09 | Acute Systemic Toxicity | Determines systemic toxic effects following a single-dose administration of extracts via applicable routes. | ISO 10993-11:2017 |
| 10 | Implantation Muscle | Evaluates local tissue responses to materials implanted intramuscularly to assess biocompatibility. | ISO 10993-6:2016 |
| 11 | Implantation Bone | Assesses the biological response of bone tissue to implanted materials for orthopedic device evaluations. | ISO 10993-6:2016 |
| 12 | Subacute Intravenous/Intraperitoneal | Determines systemic toxicity effects after repeated intravenous or intraperitoneal administration over a subacute duration. | ISO 10993-11:2017 |
| 13 | Subchronic Intravenous/Intraperitoneal | Evaluates systemic toxicity effects following repeated intravenous or intraperitoneal dosing over a subchronic period. | ISO 10993-11:2017 |
| 14 | Ocular Irritation Test | Assesses the potential of materials or extracts to cause irritation to the eye’s mucous membranes. | ISO 10993-23:2021 |
| 15 | Subacute Subcutaneous | Determines systemic toxicity effects after repeated subcutaneous administration over a subacute study period. | ISO 10993-11:2017 |
| 16 | Subchronic Subcutaneous | Evaluates systemic toxicological effects following subchronic subcutaneous exposure to test materials. | ISO 10993-11:2017 |
| 17 | Penile Irritation Test | Assesses irritation potential when materials come in contact with penile mucosa or tissue. | ISO 10993-23:2021 |
| 18 | Vaginal Irritation Test | Determines the irritation response of vaginal mucosa to medical devices or product extracts. | ISO 10993-23:2021 |
| 19 | Rectal Irritation Test | Evaluates irritation potential when materials or products are in contact with rectal mucosa. | ISO 10993-23:2021 |
| 20 | Implantation Subcutaneous | Assesses local tissue reactions to materials implanted subcutaneously to evaluate biocompatibility. | ISO 10993-6:2016 |
| 21 | Implantation Intraperitoneal | Determines the biocompatibility and local tissue response to materials implanted in the peritoneal cavity. | ISO 10993-6:2016 |
Clinical Chemistry & Pathology
Clinical chemistry studies are used to evaluate the biochemical and metabolic responses of test subjects to pharmaceutical compounds.
| No. | Study | Description |
|---|---|---|
| 01 | Liver & Renal Function Tests (LFT/RFT) | Comprehensive analysis of liver enzymes and kidney markers to monitor systemic toxicity. |
| 02 | Lipid Profile & Electrolytes | Evaluate cardiovascular and metabolic health through lipid levels and electrolyte balance. |
| 03 | Urine Analysis | Assess kidney function and detect metabolic or toxicological abnormalities via urine biomarkers. |
| 04 | Hematology | Analyze blood components including RBCs, WBCs, hemoglobin, and platelets (distinct from coagulation testing). |
| 05 | Biochemistry Analysis | Measure clinical biomarkers in serum or plasma for systemic toxicity evaluation. |
| 06 | ASTM Hemolysis Test | Evaluate hemolytic potential of substances on red blood cells under standardized conditions. |
| 07 | Coagulation Panel (PT, PTT, TT) | Assess clotting function via prothrombin, thrombin, and partial thromboplastin times. |
| 08 | Complement Assay (C3a, SC5b-9) | Measure immune response activation through complement system biomarkers. |
| 09 | Necropsy & Histopathology | Perform detailed tissue sampling, processing, immunocytochemistry and microscopic evaluation for toxicological assessment. |